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Glaucoma drainage devices

Dispositivos de drenagem para glaucoma

ABSTRACT

Glaucoma drainage devices are important therapeutic options for cases of refractory glaucoma, in which trabeculectomy with antimetabolites has shown high risk of failure. There are devices with different sizes, designs and materials, and several studies have been conducted to test their safety and effectiveness. Despite known complications, their use has progressively increased in recent years, and they are the primary surgical option, in some situations. The aim of this review is to discuss the importance, mechanisms, biomaterials, results and complications of glaucoma drainage devices.

Keywords:
Glaucoma drainage implants; Glaucoma/surgery; Intraocular pressure

RESUMO

Os dispositivos de drenagem para glaucoma são importante opção terapêutica em casos de glaucomas refratários, nos quais a trabeculectomia com antimetabólitos tem alta chance de falência. Há dispositivos com diferentes tamanhos, desenhos e materiais, e muitos estudos foram realizados para testar sua segurança e eficácia. Apesar de suas conhecidas complicações, seu uso tem aumentado progressivamente nos últimos anos, inclusive como primeira opção cirúrgica, em algumas situações. O objetivo desta revisão foi discutir a importância, os mecanismos, os biomateriais, os resultados e as complicações dos dispositivos de drenagem para glaucoma.

Descritores:
Implantes para drenagem de glaucoma; Glaucoma/cirurgia; Pressão intraocular

INTRODUCTION

Glaucoma is the main cause of irreversible blindness in the world, despite the growing innovation in its diagnosis and treatment.(11 Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90(3):262-7.) Clinical treatment is the first approach in glaucoma; however, it might not reduce intraocular pressure (IOP) to appropriate levels in some patients; thus, surgery is required.(22 Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of Various Glaucoma Surgeries and Procedures in Medicare Beneficiaries from 1994 to 2012. Ophthalmology. 2015;122(8):1615-24.)

Incisional glaucoma surgery basically consists of developing a complementary route of aqueous humor (AH) drainage, leading to the reduction of IOP. Trabeculectomy (TRAB) is the most common surgery.(22 Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of Various Glaucoma Surgeries and Procedures in Medicare Beneficiaries from 1994 to 2012. Ophthalmology. 2015;122(8):1615-24.

3 Joshi AB, Parrish RK, 2nd, Feuer WF. 2002 survey of the American Glaucoma Society: practice preferences for glaucoma surgery and antifibrotic use. J Glaucoma. 2005;14(2):172-4.
-44 Nguyen QH. Primary surgical management refractory glaucoma: tubes as initial surgery. Curr Opin Ophthalmol. 2009;20(2):122-5.) Trabeculectomy failure generally occurs by a scaring mechanism, with fibrosis of the conjunctiva and episclera, with filtering bleb (FB) ceasing to exist.(55 Broadway DC, Chang LP. Trabeculectomy, risk factors for failure and the preoperative state of the conjunctiva. J Glaucoma. 2001;10(3):237-49., 66 Skuta GL, Parrish RK, 2nd. Wound healing in glaucoma filtering surgery. Surv Ophthalmol. 1987;32(3):149-70.)

Historically, glaucoma drainage devices (GDD) have been reserved for patients at high risk of TRAB failure, such as eyes with scars in the conjunctiva due to incisional surgeries (previous TRAB, retinal surgeries with the use of explants for scleral buckling and pars plana vitrectomy – PPV); eyes with diseases causing conjunctival fibrosis; neovascular glaucoma (NVG), uveitic glaucoma, and post-penetrating keratoplasty (PK).(22 Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of Various Glaucoma Surgeries and Procedures in Medicare Beneficiaries from 1994 to 2012. Ophthalmology. 2015;122(8):1615-24.

3 Joshi AB, Parrish RK, 2nd, Feuer WF. 2002 survey of the American Glaucoma Society: practice preferences for glaucoma surgery and antifibrotic use. J Glaucoma. 2005;14(2):172-4.
-44 Nguyen QH. Primary surgical management refractory glaucoma: tubes as initial surgery. Curr Opin Ophthalmol. 2009;20(2):122-5., 77 Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC, et al. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012;153(5):804-14 e1., 88 Aref AA, Gedde SJ, Budenz DL. Glaucoma Drainage Implant Surgery. Dev Ophthalmol. 2017;59:43-52.)

In 2002, the American Glaucoma Society (AGS) prepared a questionnaire for several of its members, to collect data on their preferences in glaucoma surgeries. A significant increase was observed in the use of GDD in cases of failed TRAB, uveitic glaucoma, NVG, and some secondary glaucomas (post-cataract surgery, post-PK, post-retinal surgery with scleral introflexion, and post-PPV).(33 Joshi AB, Parrish RK, 2nd, Feuer WF. 2002 survey of the American Glaucoma Society: practice preferences for glaucoma surgery and antifibrotic use. J Glaucoma. 2005;14(2):172-4.)

Data collected from Medicare (United States health insurance) fee-for-service paid claims, from 1994 to 2012, have shown the profile of glaucoma surgeries has been changing rapidly, with a sharp drop (77%) in the number of TRAB (as first surgeries in eyes without conjunctival scaring), and with a significant increase (410%) in GDD surgeries (in different types of glaucoma). In 1994, the ratio between the number of TRAB and the number of GDD surgeries was 27:1, and then it dropped to 3:2, in 2012. With an increasing number of studies on GDD, better knowledge about their indications, more well-trained surgeons, as well as fear of TRAB failure or its FB complications, associated with the use of antimetabolites (leakage, endophthalmitis, dysesthesia), surgeries with GDD are more likely to be performed as early as possible.(22 Arora KS, Robin AL, Corcoran KJ, Corcoran SL, Ramulu PY. Use of Various Glaucoma Surgeries and Procedures in Medicare Beneficiaries from 1994 to 2012. Ophthalmology. 2015;122(8):1615-24., 44 Nguyen QH. Primary surgical management refractory glaucoma: tubes as initial surgery. Curr Opin Ophthalmol. 2009;20(2):122-5., 99 Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL. Treatment outcomes in the tube versus trabeculectomy study after one year of follow-up. Am J Ophthalmol. 2007;143(1):9-22.)

The use of GDD as a primary surgery has been discussed based on the fact that TRAB with antimetabolites might have higher risks of long-term intercurrent events, due to FB complications. The use of GDD as a primary glaucoma surgery is under study and might have better outcomes than their use after multiple surgeries, perhaps more advantageous than TRAB, since they present lower rates of complications than FB.(44 Nguyen QH. Primary surgical management refractory glaucoma: tubes as initial surgery. Curr Opin Ophthalmol. 2009;20(2):122-5.) Some studies have shown similar outcomes between TRAB and GDD, when evaluating control of IOP and complications.(77 Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC, et al. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012;153(5):804-14 e1., 1010 Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL, et al. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012;153(5):789-803 e2.

11 Wilson MR, Mendis U, Paliwal A, Haynatzka V. Long-term follow-up of primary glaucoma surgery with Ahmed glaucoma valve implant versus trabeculectomy. Am J Ophthalmol. 2003;136(3):464-70.

12 Minckler DS, Francis BA, Hodapp EA, Jampel HD, Lin SC, Samples JR, et al. Aqueous shunts in glaucoma: a report by the American Academy of Ophthalmology. Ophthalmology. 2008;115(6):1089-98.

13 Nguyen QH, Budenz DL, Parrish RK, 2nd. Complications of Baerveldt glaucoma drainage implants. Arch Ophthalmol. 1998;116(5):571-5.

14 Panarelli JF, Banitt MR, Gedde SJ, Shi W, Schiffman JC, Feuer WJ. A Retrospective Comparison of Primary Baerveldt Implantation versus Trabeculectomy with Mitomycin C. Ophthalmology. 2016;123(4):789-95.
-1515 Molteno AC, Bevin TH, Herbison P, Husni MA. Long-term results of primary trabeculectomies and Molteno implants for primary open-angle glaucoma. Arch Ophthalmol. 2011;129(11):1444-50.) The Primary Tube Versus Trabeculectomy Study (PTVT) is an ongoing study comparing safety and efficacy of tube shunt implantation versus TRAB with mitomycin C (MMC) in eyes with uncomplicated open-angle glaucoma, with no previous incisional surgery. The three-year results showed that the TRAB group had lower IOP requiring fewer glaucoma medication.(1616 Gedde SJ, Feuer WJ, Shi W, Lim KS, Barton K, Goyal S, et al. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up. Ophthalmology. 2018;125(5):650-63.) Another study, Tube Versus Trabeculectomy (TVT), showed that, for eyes with previous cataract and/or glaucoma surgery, GDD showed slightly better results regarding reduction in IOP and number of hypotensive medications.(1010 Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL, et al. Treatment outcomes in the Tube Versus Trabeculectomy (TVT) study after five years of follow-up. Am J Ophthalmol. 2012;153(5):789-803 e2.)

The four most often used GDD are (Figure 1):(1717 Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011;118(3):443-52.,1818 Schwartz KS, Lee RK, Gedde SJ. Glaucoma drainage implants: a critical comparison of types. Curr Opin Ophthalmol. 2006;17(2):181-9.) Ahmed glaucoma valves (AGV), New World Medical®, Rancho Cucamonga, CA; Baerveldt® glaucoma implant (BGI), Abbott Medical Optics®, Santa Barbara, CA; Molteno implant (MI) (Molteno Ophthalmic Limited®, Dunedin, New Zealand); and Implante de Susanna UF (Adapt, Brazil).

Figure 1
Glaucoma drainage devices. (A) Ahmed glaucoma valve; (B) Baerveldt® glaucoma implant; (C) double-plate and single-plate Molteno implant; (D) Susanna implant.

Each device has different models and plate materials, according to Table 1.(1919 Discover Molteno3® for glaucoma. [cited 2022 Mar 3]. Available from: https://glaucoma-molteno.com/
https://glaucoma-molteno.com/...

20 Molteno AC. New implant for drainage in glaucoma. Clinical trial. Br J Ophthalmol. 1969;53(9):606-15.

21 BAERVELDT® glaucoma implants. [cited 2022 Mar 9]. Available from: https://www.jnjvisionpro.com/products/baerveldt%C2%AE-glaucoma-implants
https://www.jnjvisionpro.com/products/ba...

22 Lloyd MA, Baerveldt G, Fellenbaum PS, Sidoti PA, Minckler DS, Martone JF, et al. Intermediate-term results of a randomized clinical trial of the 350- versus the 500-mm2 Baerveldt implant. Ophthalmology. 1994;101(8):1456-63; discussion 63-4.

23 Siegner SW, Netland PA, Urban RC, Jr., Williams AS, Richards DW, Latina MA, et al. Clinical experience with the Baerveldt glaucoma drainage implant. Ophthalmology. 1995;102(9):1298-307.

24 Smith SL, Starita RJ, Fellman RL, Lynn JR. Early clinical experience with the Baerveldt 350-mm2 glaucoma implant and associated extraocular muscle imbalance. Ophthalmology. 1993;100(6):914-8.

25 Alhmed® glaucoma valve. [cited 2022 Mar 09]. Available from: https://www.newworldmedical.com/ahmed-glaucoma-valve/
https://www.newworldmedical.com/ahmed-gl...

26 Coleman AL, Hill R, Wilson MR, Choplin N, Kotas-Neumann R, Tam M, et al. Initial clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1995;120(1):23-31.
-2727 Biteli LG, Prata TS, Gracitelli CP, Kanadani FN, Villas Boas F, Hatanaka M, et al. Evaluation of the Efficacy and Safety of the New Susanna Glaucoma Drainage Device in Refractory Glaucomas: Short-term Results. J Glaucoma. 2017;26(4):356-60.)

Table 1
Characteristics of the most commonly used glaucoma drainage devices

In 2016, Susanna implant was launched in Brazil, with a design similar to that of traditional GDD, also having a silicone tube and an episcleral plate, both thinner than the other three devices mentioned (Figure 1).(2727 Biteli LG, Prata TS, Gracitelli CP, Kanadani FN, Villas Boas F, Hatanaka M, et al. Evaluation of the Efficacy and Safety of the New Susanna Glaucoma Drainage Device in Refractory Glaucomas: Short-term Results. J Glaucoma. 2017;26(4):356-60.)

THE OPERATING MECHANISM OF GLAUCOMA DRAINAGE DEVICES MOST COMMONLY USED: MOLTENO®, BAERVELDT®, AND AHMED®

The reasoning behind the operating mechanism of GDD is to drive the AH from the anterior chamber through a silicone tube to a reservoir formed around the GDD plate, located posteriorly in the subconjunctival space and externally confined by a fibrous capsule. Aqueous humor crosses this capsule by passive diffusion, between the collagenous fibers, and is absorbed by capillaries and lymphatic vessels from the Tenon's capsule and conjunctiva. The capsule involving the plate is the most resistant site to AH flow.(88 Aref AA, Gedde SJ, Budenz DL. Glaucoma Drainage Implant Surgery. Dev Ophthalmol. 2017;59:43-52., 1818 Schwartz KS, Lee RK, Gedde SJ. Glaucoma drainage implants: a critical comparison of types. Curr Opin Ophthalmol. 2006;17(2):181-9., 2828 Philipp W, Klima G, Miller K. Clinicopathological findings 11 months after implantation of a functioning aqueous-drainage silicone implant. Graefes Arch Clin Exp Ophthalmol. 1990;228(5):481-6.

29 Wilcox MJ, Minckler DS, Ogden TE. Pathophysiology of artificial aqueous drainage in primate eyes with molteno implants. J Glaucoma. 1994;3(2):140-51.

30 Prata JAJ. Aspectos Funcionais dos implantes para Glaucoma. Livre Docência. 2001. Universidade Federal de São Paulo - Escola Paulista de Medicina. APUD: Prata JA, Jr., Omi CA. Implantes para Glaucoma. In: Dias JP, Almeida HG, Prata JAJ, editors. Glaucoma: Cultura Médica: Guanabara Koogan; 2010. p. 643-59. 2001.

31 Minckler DS. Pathophysiology of artificial drainage devices. In: Minckler, D.S, van-Burskirk EM. Color Atlas of ophthalmic surgery: glaucoma. Philadelphia: Lippincott; 1992.

32 Molteno AC, Van Biljon G, Ancker E. Two stage insertion of glaucoma drainage implants. Trans Ophthalmol Soc NZ. 1979;31:17-26.
-3333 Cameron JD, White TC. Clinico-histopathologic correlation of a successful glaucoma pump-shunt implant. Ophthalmology. 1988;95(9):1189-94.) The plate prevents the conjunctival adhesion to the sclera and its presence maintains the AH reservoir.(88 Aref AA, Gedde SJ, Budenz DL. Glaucoma Drainage Implant Surgery. Dev Ophthalmol. 2017;59:43-52.) With adequate surgical technique, patients will have the aspect shown in Figure 2.

Figure 2
Anterior segment biomicroscopy of implanted glaucoma drainage devices: (A) Aspect of the silicone tube in the periphery of the anterior chamber; (B) same eye with patch graft; G: sutured to underlying sclera (arrows) and B: bleb, overlying the glaucoma drainage device plate.

Molteno described three IOP oscillation phases, which occur after non-valved GDD implantation, when no tube ligature is used: hypotonic, hypertensive, and controlled IOP phase (balance).(2020 Molteno AC. New implant for drainage in glaucoma. Clinical trial. Br J Ophthalmol. 1969;53(9):606-15.) The first phase may last up to 30 days after implantation, and occurs because there is not enough time for the fibrous capsule to be formed around the plate, which is able to restrict the AH flow. Next, there is the hypertensive phase lasting from six to 12 weeks, when the capsule becomes thick, swollen and inflamed, with a low permeability to AH, reducing its reabsorption and causing increased IOP. In this phase, IOP rises and the pressure of AH on the capsule, together with proinflammatory substances present in it, contribute to fibrosis, thickening, and greater inflammation of the fibrovascular tissue. The third phase (balance) is characterized by a FB with no inflammatory reaction, with the implant capsule already remodeled and thinner, with more permeability to AH, establishing a stable control of IOP.(2020 Molteno AC. New implant for drainage in glaucoma. Clinical trial. Br J Ophthalmol. 1969;53(9):606-15., 3030 Prata JAJ. Aspectos Funcionais dos implantes para Glaucoma. Livre Docência. 2001. Universidade Federal de São Paulo - Escola Paulista de Medicina. APUD: Prata JA, Jr., Omi CA. Implantes para Glaucoma. In: Dias JP, Almeida HG, Prata JAJ, editors. Glaucoma: Cultura Médica: Guanabara Koogan; 2010. p. 643-59. 2001., 3434 Freedman J. What is new after 40 years of glaucoma implants. J Glaucoma. 2010;19(8):504-8.

35 Yuen D, Buys Y, Jin YP, Alasbali T, Smith M, Trope GE. Corticosteroids versus NSAIDs on intraocular pressure and the hypertensive phase after Ahmed glaucoma valve surgery. J Glaucoma. 2011;20(7):439-44.

36 Nouri-Mahdavi K, Caprioli J. Evaluation of the hypertensive phase after insertion of the Ahmed Glaucoma Valve. Am J Ophthalmol. 2003;136(6):1001-8.

37 Hong CH, Arosemena A, Zurakowski D, Ayyala RS. Glaucoma drainage devices: a systematic literature review and current controversies. Surv Ophthalmol. 2005;50(1):48-60.

38 Chaudhry M, Grover S, Baisakhiya S, Bajaj A, Bhatia MS. Artificial drainage devices for glaucoma surgery: an overview. Nepal J Ophthalmol. 2012;4(2):295-302.

39 Pakravan M, Rad SS, Yazdani S, Ghahari E, Yaseri M. Effect of early treatment with aqueous suppressants on Ahmed glaucoma valve implantation outcomes. Ophthalmology. 2014;121(9):1693-8.

40 Jacob JT, Burgoyne CF, McKinnon SJ, Tanji TM, LaFleur PK, Duzman E. Biocompatibility response to modified Baerveldt glaucoma drains. J Biomed Mater Res. 1998;43(2):99-107.

41 Boswell CA, Noecker RJ, Mac M, Snyder RW, Williams SK. Evaluation of an aqueous drainage glaucoma device constructed of ePTFE. J Biomed Mater Res. 1999;48(5):591-5.
-4242 Sarkisian SR, Jr. Tube shunt complications and their prevention. Curr Opin Ophthalmol. 2009;20(2):126-30.)

Area of the glaucoma drainage device and a successful control of intraocular pressure

Several studies have shown the IOP-lowering effect increases, but not proportionally, with the increase in plate size with areas over 170 mm2 to 250 mm2. Thus, single-plate GDD have pressure effects that are little different from those of double-plate implants, as well as those with larger plates when compared to smaller plates.(1818 Schwartz KS, Lee RK, Gedde SJ. Glaucoma drainage implants: a critical comparison of types. Curr Opin Ophthalmol. 2006;17(2):181-9., 2222 Lloyd MA, Baerveldt G, Fellenbaum PS, Sidoti PA, Minckler DS, Martone JF, et al. Intermediate-term results of a randomized clinical trial of the 350- versus the 500-mm2 Baerveldt implant. Ophthalmology. 1994;101(8):1456-63; discussion 63-4., 3434 Freedman J. What is new after 40 years of glaucoma implants. J Glaucoma. 2010;19(8):504-8., 4343 Heuer DK, Lloyd MA, Abrams DA, Baerveldt G, Minckler DS, Lee MB, et al. Which is better? One or two? A randomized clinical trial of single-plate versus double-plate Molteno implantation for glaucomas in aphakia and pseudophakia. Ophthalmology. 1992;99(10):1512-9.

44 Britt MT, LaBree LD, Lloyd MA, Minckler DS, Heuer DK, Baerveldt G, et al. Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? Ophthalmology. 1999;106(12):2312-8.

45 Mills RP, Reynolds A, Emond MJ, Barlow WE, Leen MM. Long-term survival of Molteno glaucoma drainage devices. Ophthalmology. 1996;103(2):299-305.
-4646 Allan EJ, Khaimi MA, Jones JM, Ding K, Skuta GL. Long-term efficacy of the Baerveldt 250 mm2 compared with the Baerveldt 350 mm2 implant. Ophthalmology. 2015;122(3):486-93.) Possibly, larger implants might form a more fibrous capsule, by creating very large FB, since tension on the capsule's inner wall would be exponentially proportional to the diameter of FB, according to the Laplace law. Moreover, capsules with larger diameters experienced greater tension than those with smaller diameters, when submitted to the same pressure, as per the same law. Thus, thicker capsules would be more likely to nullify the benefit from a larger area of AH drainage.(4444 Britt MT, LaBree LD, Lloyd MA, Minckler DS, Heuer DK, Baerveldt G, et al. Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? Ophthalmology. 1999;106(12):2312-8., 4747 Lim KS, Allan BD, Lloyd AW, Muir A, Khaw PT. Glaucoma drainage devices; past, present, and future. Br J Ophthalmol. 1998;82(9):1083-9.) In cases in which implantation is difficult, such as in small eye sockets or in eyes submitted to previous conjunctival procedures, GDD with smaller plates seem to be a better option.(4646 Allan EJ, Khaimi MA, Jones JM, Ding K, Skuta GL. Long-term efficacy of the Baerveldt 250 mm2 compared with the Baerveldt 350 mm2 implant. Ophthalmology. 2015;122(3):486-93.)

Valved and non-valved drainage devices

The purpose of the valve is to avoid postoperative hypotony and its complications. This idea was first introduced by Krupin et al., in 1976, with a device that was a tube with a unidirectional valve mechanism. This device had a tip in the anterior chamber and was fixed under a scleral flap, without a plate in contact with the conjunctiva, and the AH was drained to subconjunctival space, as in a TRAB.(4848 Krupin T, Podos SM, Becker B, Newkirk JB. Valve implants in filtering surgery. Am J Ophthalmol. 1976;81(2):232-5.) Modern GDD may be valved, such as the AGV (Figure 1A), or non-valved, such as BGI, MI, and Susanna (Figures 1B, 1C and 1D). In case of a non-valved implant, a temporary restriction of the AH flow is required, which may be placed by the tube ligation with an absorbable suture or by placing a suture thread in the tube lumen, and this suture thread may be removed some weeks after surgery, as required. Thus, a temporary restriction on AH flow occurs in the initial phase after the implantation, until a capsule is formed around the plate, restricting flow and preventing hypotony.(4949 Molteno AC, Polkinghorne PJ, Bowbyes JA. The vicryl tie technique for inserting a draining implant in the treatment of secondary glaucoma. Aust N Z J Ophthalmol. 1986;14(4):343-54., 5050 Sherwood MB, Smith MF. Prevention of early hypotony associated with Molteno implants by a new occluding stent technique. Ophthalmology. 1993;100(1):85-90.) As to the valved implant, there is already a flow restriction mechanism, with the advantage of having an immediate reduction in IOP in the postoperative period.(1717 Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011;118(3):443-52., 5151 Gedde SJ, Panarelli JF, Banitt MR, Lee RK. Evidenced-based comparison of aqueous shunts. Curr Opin Ophthalmol. 2013;24(2):87-95.

52 Tsai JC, Johnson CC, Kammer JA, Dietrich MS. The Ahmed shunt versus the Baerveldt shunt for refractory glaucoma II: longer-term outcomes from a single surgeon. Ophthalmology. 2006;113(6):913-7.
-5353 Christakis PG, Kalenak JW, Zurakowski D, Tsai JC, Kammer JA, Harasymowycz PJ, et al. The Ahmed Versus Baerveldt study: one-year treatment outcomes. Ophthalmology. 2011;118(11):2180-9.) In theory, the AGV is programmed to close the valve in cases of IOP of approximately 8 mmHg.(2626 Coleman AL, Hill R, Wilson MR, Choplin N, Kotas-Neumann R, Tam M, et al. Initial clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1995;120(1):23-31.) Nevertheless, the presence of a valve or the presence of tube ligation does not guarantee protection against hypotony, since these mechanisms may not work perfectly, in addition to a possible peritubular leakage in the scleral foramen.(2626 Coleman AL, Hill R, Wilson MR, Choplin N, Kotas-Neumann R, Tam M, et al. Initial clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1995;120(1):23-31., 4747 Lim KS, Allan BD, Lloyd AW, Muir A, Khaw PT. Glaucoma drainage devices; past, present, and future. Br J Ophthalmol. 1998;82(9):1083-9., 5454 Huddleston SM, Feldman RM, Budenz DL, Bell NP, Lee DA, Chuang AZ, et al. Aqueous shunt exposure: a retrospective review of repair outcome. J Glaucoma. 2013;22(6):433-8.

55 Porter JM, Krawczyk CH, Carey RF. In vitro flow testing of glaucoma drainage devices. Ophthalmology. 1997;104(10):1701-7.

56 Prata JA, Jr., Mermoud A, LaBree L, Minckler DS. In vitro and in vivo flow characteristics of glaucoma drainage implants. Ophthalmology. 1995;102(6):894-904.

57 Trible JR, Brown DB. Occlusive ligature and standardized fenestration of a Baerveldt tube with and without antimetabolites for early postoperative intraocular pressure control. Ophthalmology. 1998;105(12):2243-50.

58 Goulet RJ, 3rd, Phan AD, Cantor LB, WuDunn D. Efficacy of the Ahmed S2 glaucoma valve compared with the Baerveldt 250-mm2 glaucoma implant. Ophthalmology. 2008;115(7):1141-7.
-5959 Moss EB, Trope GE. Assessment of closing pressure in silicone Ahmed FP7 glaucoma valves. J Glaucoma. 2008;17(6):489-93.)

In the case of AGV, the AH reaches the tissues covering the device immediately after the surgery, stimulating the formation of a fibrous capsule due to proinflammatory substances in AH. This partially explains a more pronounced hypertensive phase of this GDD.(6060 Epstein E. Fibrosing response to aqueous. Its relation to glaucoma. Br J Ophthalmol. 1959;43(11):641-7.

61 Molteno AC, Thompson AM, Bevin TH, Dempster AG. Otago glaucoma surgery outcome study: tissue matrix breakdown by apoptotic cells in capsules surrounding molteno implants. Invest Ophthalmol Vis Sci. 2009;50(3):1187-97.

62 Molteno AC, Fucik M, Dempster AG, Bevin TH. Otago Glaucoma Surgery Outcome Study: factors controlling capsule fibrosis around Molteno implants with histopathological correlation. Ophthalmology. 2003;110(11):2198-206.

63 Jampel HD, Roche N, Stark WJ, Roberts AB. Transforming growth factor-beta in human aqueous humor. Curr Eye Res. 1990;9(10):963-9.
-6464 Tripathi RC, Borisuth NS, Li J, Tripathi BJ. Growth factors in the aqueous humor and their clinical significance. J Glaucoma. 1994;3(3):248-58.)

Studies comparing valved devices (AGV) to non-valved devices (BGI) have not shown significant differences in IOP control nor in rate of complications, although the BGI group has required a smaller number of hypotensive drugs and has had a larger number of hypotony-related complications.(5252 Tsai JC, Johnson CC, Kammer JA, Dietrich MS. The Ahmed shunt versus the Baerveldt shunt for refractory glaucoma II: longer-term outcomes from a single surgeon. Ophthalmology. 2006;113(6):913-7., 5858 Goulet RJ, 3rd, Phan AD, Cantor LB, WuDunn D. Efficacy of the Ahmed S2 glaucoma valve compared with the Baerveldt 250-mm2 glaucoma implant. Ophthalmology. 2008;115(7):1141-7., 6565 Syed HM, Law SK, Nam SH, Li G, Caprioli J, Coleman A. Baerveldt-350 implant versus Ahmed valve for refractory glaucoma: a case-controlled comparison. J Glaucoma. 2004;13(1):38-45.) It is important to highlight that AGV S2 has a polypropylene plate, whereas BGI has a silicone one. Another important factor is that AGV is valved and is more likely to have encapsulation, with a longer hypertensive phase. Thus, more than one variable may have influenced the outcomes.(5858 Goulet RJ, 3rd, Phan AD, Cantor LB, WuDunn D. Efficacy of the Ahmed S2 glaucoma valve compared with the Baerveldt 250-mm2 glaucoma implant. Ophthalmology. 2008;115(7):1141-7.) Compared to AGV, BGI has shown a slightly better IOP reduction, but it has higher incidence of complications, such as hypotony and evolution to no light perception.(6666 Budenz DL, Barton K, Gedde SJ, Feuer WJ, Schiffman J, Costa VP, et al. Five-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology. 2015;122(2):308-16.

67 Christakis PG, Kalenak JW, Tsai JC, Zurakowski D, Kammer JA, Harasymowycz PJ, et al. The Ahmed Versus Baerveldt Study: Five-Year Treatment Outcomes. Ophthalmology. 2016;123(10):2093-102.
-6868 Christakis PG, Zhang D, Budenz DL, Barton K, Tsai JC, Ahmed IIK; ABC-AVB Study Groups. Five-Year Pooled Data Analysis of the Ahmed Baerveldt Comparison Study and the Ahmed Versus Baerveldt Study. Am J Ophthalmol. 2017 Apr;176:118-126.)

Hong et al. surveyed several studies with GDD and reported the incidence of encapsulation in patients who received AGV ranged from 40% to 80%, whereas in those who received BGI or MI with a double plate, it ranged from 20% to 30%.(3737 Hong CH, Arosemena A, Zurakowski D, Ayyala RS. Glaucoma drainage devices: a systematic literature review and current controversies. Surv Ophthalmol. 2005;50(1):48-60.) Schwartz et al. reported a preference for using BGI, since a long-term IOP control was observed, always employing the technique of ligature and fenestration of the silicone tube. Nevertheless, these authors informed preferring AGV in cases of uveitis and in those previously submitted to a cyclodestructive procedure, since the AH production may be reduced leading to hypotony.(1818 Schwartz KS, Lee RK, Gedde SJ. Glaucoma drainage implants: a critical comparison of types. Curr Opin Ophthalmol. 2006;17(2):181-9.)

Biomaterials

All synthetic materials cause an inflammatory response of the receptor tissue. The inflammatory reaction generally leads to material encapsulation by a fibrous layer rich in collagen.(6969 Orefice RL. Materiais poliméricos - Ciência e aplicação como biomateriais. In: Orefice RL, Pereira MM, Mansur HS, editors. Biomateriais: fundamentos e aplicações. Rio de Janeiro: Cultura Médica: Guanabara Koogan; 2012. p. 87-155.) An aggravated inflammatory process around the GDD plate results in a very thick fibrous capsule, being the main cause of failure of this therapeutic modality.(7070 Molteno ACB, Dempster AG. Methods of controlling bleb fibrosis around draining implats. In: Mills KB, ed. Glaucoma: Proceedings of Fourth International Symposium of the Northern Eye Institute, Manchester UK. Oxford, England: Pergammon Press; 1988. APUD: Ayyala RS, Michelini-Norris B, Flores A, Haller E, Margo CE. Comparison of Different Biomaterials for Glaucoma Drainage Devices. Part 2. Arch Ophthalmol. 2000; 118(8):1081-4.) The inflammation around the plate is influenced by other characteristics in addition to the biomaterial it is made of, such as its size, shape and flexibility.(7171 Ayyala RS, Michelini-Norris B, Flores A, Haller E, Margo CE. Comparison of different biomaterials for glaucoma drainage devices: part 2. Arch Ophthalmol. 2000;118(8):1081-4.) Thus, the ideal GDD should be made of a completely inert material or of relative biological inactivity.(7171 Ayyala RS, Michelini-Norris B, Flores A, Haller E, Margo CE. Comparison of different biomaterials for glaucoma drainage devices: part 2. Arch Ophthalmol. 2000;118(8):1081-4., 7272 Prata JA, Jr., Almeida HG, Dias JFP. Introdução ao glaucoma. . In: Dias JFP, Almeida HG, Prata JAJ, editors. Glaucoma. 4a ed. Rio de Janeiro: Cultura Médica: Guanabara Koogan; 2010. p. 3-9.)

Polypropylene is used in MI and in AGV. Silicone is used in Krupin, Schocket, Susanna, and Baerveldt® implants and in some models of AGV.(7373 Werner L, Werner LP. Biomateriais utilizados na fabricação de lentes intraoculares. In: Orefice RL, Pereira MM, Mansur HS, editors. Biomateriais: fundamentos e aplicações. Rio de Janeiro: Cultura Médica : Guanabara Koogan; 2012. p. 407-21., 7474 Kim J, Allingham RR, Hall J, Klitzman B, Stinnett S, Asrani S. Clinical experience with a novel glaucoma drainage implant. J Glaucoma. 2014;23(2):e91-7.) Studies conducted using rabbits, with the implantation of biomaterials in the subconjunctival space, have shown that silicone induces less inflammatory reaction than polypropylene and PMMA.(7171 Ayyala RS, Michelini-Norris B, Flores A, Haller E, Margo CE. Comparison of different biomaterials for glaucoma drainage devices: part 2. Arch Ophthalmol. 2000;118(8):1081-4., 7575 Ayyala RS, Harman LE, Michelini-Norris B, Ondrovic LE, Haller E, Margo CE, et al. Comparison of different biomaterials for glaucoma drainage devices. Arch Ophthalmol. 1999;117(2):233-6.) Most studies comparing polypropylene and silicone AGV have shown a better control of IOP with those using silicone.(7676 Ishida K, Netland PA, Costa VP, Shiroma L, Khan B, Ahmed, II. Comparison of polypropylene and silicone Ahmed Glaucoma Valves. Ophthalmology. 2006;113(8):1320-6.

77 El Sayed Y, Awadein A. Polypropylene vs silicone Ahmed valve with adjunctive mitomycin C in paediatric age group: a prospective controlled study. Eye (Lond). 2013;27(6):728-34.

78 Mackenzie PJ, Schertzer RM, Isbister CM. Comparison of silicone and polypropylene Ahmed glaucoma valves: two-year follow-up. Can J Ophthalmol. 2007;42(2):227-32.
-7979 Law SK, Nguyen A, Coleman AL, Caprioli J. Comparison of safety and efficacy between silicone and polypropylene Ahmed glaucoma valves in refractory glaucoma. Ophthalmology. 2005;112(9):1514-20.)

Micromovement of the device and its influence on the thickness of the capsule

It is difficult for a GDD with a very smooth surface to be incorporated by the organism, since there are no holes for tissue growth in it, which prevents a perfect attachment to the implantation site. Thus, micromovements occur, which maintain an ongoing trauma, leading to a more intense inflammatory reaction, and to the formation of thicker capsules. Thus, some GDD surface roughness is desirable since it increases the adhesion of the device to its implantation site, reducing micromovements, with a subsequent formation of thinner capsules.(4747 Lim KS, Allan BD, Lloyd AW, Muir A, Khaw PT. Glaucoma drainage devices; past, present, and future. Br J Ophthalmol. 1998;82(9):1083-9., 7373 Werner L, Werner LP. Biomateriais utilizados na fabricação de lentes intraoculares. In: Orefice RL, Pereira MM, Mansur HS, editors. Biomateriais: fundamentos e aplicações. Rio de Janeiro: Cultura Médica : Guanabara Koogan; 2012. p. 407-21.) Since the eyes move under extraocular muscles and under Tenon's connective tissue, GDD on the scleral surface may have micromovements that may maintain the low-grade chronic inflammatory reaction activated, which may cause an excessive scarring that forms a very thick collagenous capsule.(4040 Jacob JT, Burgoyne CF, McKinnon SJ, Tanji TM, LaFleur PK, Duzman E. Biocompatibility response to modified Baerveldt glaucoma drains. J Biomed Mater Res. 1998;43(2):99-107., 4747 Lim KS, Allan BD, Lloyd AW, Muir A, Khaw PT. Glaucoma drainage devices; past, present, and future. Br J Ophthalmol. 1998;82(9):1083-9.)

GDD have holes through which they may be attached to the sclera. BGI has fenestrations in its plate that allow for the formation of vertical fibrous bands connecting the sclera to the roof of FB, avoiding a dramatic rise of the capsule of the implant.(1818 Schwartz KS, Lee RK, Gedde SJ. Glaucoma drainage implants: a critical comparison of types. Curr Opin Ophthalmol. 2006;17(2):181-9., 8080 Baerveldt G, Blake LW, Wright GM. GLAUCOMA IMPLANT. US Pat. 5,397,300, Mar.14, 1995. 11p.) The MI has four fenestrations in its plate: two anterior ones and two posterior ones. The four holes may be used to attach GDD to the sclera, although only two anterior holes are usually used to attach the plate to the sclera.(8181 Molteno AC. Ophthalmic implant for treating glaucoma. US Pat. 7,776,002 B2, Aug. 17, 2010. 10p.)

POSTOPERATIVE COMPLICATIONS

Glaucoma drainage devices are some of the few therapeutic options in patients with glaucoma refractory to clinical and surgical treatment with TRAB. Although they have been effective to reduce IOP, their use is not free from complications. Applying the appropriate surgical technique with the proper patient selection are important factors that reduce the incidence of complications.(4242 Sarkisian SR, Jr. Tube shunt complications and their prevention. Curr Opin Ophthalmol. 2009;20(2):126-30.) Early complications occur within the first postoperative month and late complications after the first month. Early complications include shallow or flat anterior chamber, choroidal detachment (CD), conjunctival leakage of AH, hyphema, wound dehiscence, endophthalmitis, and strabismus. Late complications include shallow or flat anterior chamber, CD, strabismus, endothelial cell loss and corneal decompensation, exposure of drainage device, endophthalmitis, retinal detachment, phthisis bulbi, and reduction of visual acuity (VA).(1616 Gedde SJ, Feuer WJ, Shi W, Lim KS, Barton K, Goyal S, et al. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up. Ophthalmology. 2018;125(5):650-63.)

Hypotony, shallow anterior chamber and choroidal detachment

The presence of valve or ligature of the silicone tube with a nonabsorbable suture does not ensure protection against hypotony, which is generally caused by the excessive flow of AH through the fistula.(8282 Spaeth GL. Glaucoma surgery. In: Saunders W, ed. Ophthalmic Surgery: Principles and Practice. 2nd ed. Philadelphia; 1990.

83 Schrieber C, Liu Y. Choroidal effusions after glaucoma surgery. Curr Opin Ophthalmol. 2015;26(2):134-42.
-8484 Panarelli JF, Nayak NV, Sidoti PA. Postoperative management of trabeculectomy and glaucoma drainage implant surgery. Curr Opin Ophthalmol. 2016;27(2):170-6.) Another possible mechanism of hypotony is decreased AH production by an intense intraocular inflammation.(8484 Panarelli JF, Nayak NV, Sidoti PA. Postoperative management of trabeculectomy and glaucoma drainage implant surgery. Curr Opin Ophthalmol. 2016;27(2):170-6.) Some possible complications include shallow anterior chamber, serous or hemorrhagic CD, hypotony maculopathy, and worsening or development of cataract.(4747 Lim KS, Allan BD, Lloyd AW, Muir A, Khaw PT. Glaucoma drainage devices; past, present, and future. Br J Ophthalmol. 1998;82(9):1083-9., 8282 Spaeth GL. Glaucoma surgery. In: Saunders W, ed. Ophthalmic Surgery: Principles and Practice. 2nd ed. Philadelphia; 1990.

83 Schrieber C, Liu Y. Choroidal effusions after glaucoma surgery. Curr Opin Ophthalmol. 2015;26(2):134-42.
-8484 Panarelli JF, Nayak NV, Sidoti PA. Postoperative management of trabeculectomy and glaucoma drainage implant surgery. Curr Opin Ophthalmol. 2016;27(2):170-6.)

Extra care should be taken to perform sclerostomy, through which the silicone tube will pass into the inner eye. This foramen should be opened with a 22G or a 23G needle, so it is not too wide, predisposing peritubular leakage with a subsequent hypotony.(4242 Sarkisian SR, Jr. Tube shunt complications and their prevention. Curr Opin Ophthalmol. 2009;20(2):126-30., 8585 Bailey AK, Sarkisian SR, Jr. Complications of tube implants and their management. Curr Opin Ophthalmol. 2014;25(2):148-53., 8686 Garcia-Feijoo J, Cuina-Sardina R, Mendez-Fernandez C, Castillo-Gomez A, Garcia-Sanchez J. Peritubular filtration as cause of severe hypotony after Ahmed valve implantation for glaucoma. Am J Ophthalmol. 2001;132(4):571-2.) Regarding AGV, Sarkisian and Bailey et al. recommended to be careful, not vigorously performing priming of the valve, to avoid damaging it.(4242 Sarkisian SR, Jr. Tube shunt complications and their prevention. Curr Opin Ophthalmol. 2009;20(2):126-30., 8585 Bailey AK, Sarkisian SR, Jr. Complications of tube implants and their management. Curr Opin Ophthalmol. 2014;25(2):148-53.)

Glaucoma drainage devices with a larger drainage area have a greater success in controlling the IOP, with a major risk of hypotony. This applies both to comparisons among single-plate devices with different areas, and as well as the same GDD with a single plate versus a double plate.

Postoperative shallow anterior chamber may result from hypotony or, less frequently, from CD.(8282 Spaeth GL. Glaucoma surgery. In: Saunders W, ed. Ophthalmic Surgery: Principles and Practice. 2nd ed. Philadelphia; 1990.) As a complication from shallow anterior chamber, an endothelial injury may occur resulting from the touch of the tube to the corneal endothelium, as well as from the touch of the iris or the iris with the crystalline lens.(4747 Lim KS, Allan BD, Lloyd AW, Muir A, Khaw PT. Glaucoma drainage devices; past, present, and future. Br J Ophthalmol. 1998;82(9):1083-9., 8282 Spaeth GL. Glaucoma surgery. In: Saunders W, ed. Ophthalmic Surgery: Principles and Practice. 2nd ed. Philadelphia; 1990.) The formation of peripheral anterior synechiae may also result from iridocorneal touch. In cases of shallow anterior chamber with peripheral iridocorneal touch (grade 1 shallow AC), the clinical treatment is effective. In cases of flat AC (grade 3 shallow AC), with crystalline lens-corneal touch, an urgent surgery is required, with the purpose of reducing the flow of AH through the fistula. In cases of shallow anterior chamber with a total iridocorneal touch, with no crystalline lens-cornea touch (grade 2 shallow AC), it is recommended to reform the anterior chamber with a viscoelastic substance, although there is the option of clinical treatment or surgical drainage of CD.(8282 Spaeth GL. Glaucoma surgery. In: Saunders W, ed. Ophthalmic Surgery: Principles and Practice. 2nd ed. Philadelphia; 1990.)

Serous CD, also called uveal effusion, is likely to occur because of the fluid transudation from the suprachoroidal capillaries, due to the change in the pressure gradient resulting from hypotony. In the hemorrhagic CD, also called suprachoroidal hemorrhage, a possible cause would be by rupture of posterior ciliary vessels, caused by a sudden drop in IOP and/or vessel stretching by a previously present small serous CD. Both types of CD may occur in the transoperative or postoperative period. Serous CD is usually benign and clinically treated, without causing VA loss. Hemorrhagic CD has the worst visual prognosis, particularly when it occurs during surgery, with expulsive hemorrhage. In CD, there may be an involvement of the ciliary body, with a decrease in AH production, which maintains and aggravates the hypotonic condition, creating a vicious cycle that perpetuates this condition and may lead to fistula failure, by a drastic reduction in the flow.(8383 Schrieber C, Liu Y. Choroidal effusions after glaucoma surgery. Curr Opin Ophthalmol. 2015;26(2):134-42.) In the literature, the incidence of serous CD after GDD surgeries ranged from 0% to 22%. In few cases, serous CD was more severe, requiring drainage.(77 Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC, et al. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012;153(5):804-14 e1., 1414 Panarelli JF, Banitt MR, Gedde SJ, Shi W, Schiffman JC, Feuer WJ. A Retrospective Comparison of Primary Baerveldt Implantation versus Trabeculectomy with Mitomycin C. Ophthalmology. 2016;123(4):789-95., 1515 Molteno AC, Bevin TH, Herbison P, Husni MA. Long-term results of primary trabeculectomies and Molteno implants for primary open-angle glaucoma. Arch Ophthalmol. 2011;129(11):1444-50., 1717 Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011;118(3):443-52., 2222 Lloyd MA, Baerveldt G, Fellenbaum PS, Sidoti PA, Minckler DS, Martone JF, et al. Intermediate-term results of a randomized clinical trial of the 350- versus the 500-mm2 Baerveldt implant. Ophthalmology. 1994;101(8):1456-63; discussion 63-4., 2626 Coleman AL, Hill R, Wilson MR, Choplin N, Kotas-Neumann R, Tam M, et al. Initial clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1995;120(1):23-31., 4343 Heuer DK, Lloyd MA, Abrams DA, Baerveldt G, Minckler DS, Lee MB, et al. Which is better? One or two? A randomized clinical trial of single-plate versus double-plate Molteno implantation for glaucomas in aphakia and pseudophakia. Ophthalmology. 1992;99(10):1512-9., 4545 Mills RP, Reynolds A, Emond MJ, Barlow WE, Leen MM. Long-term survival of Molteno glaucoma drainage devices. Ophthalmology. 1996;103(2):299-305., 8787 Ayyala RS, Zurakowski D, Smith JA, Monshizadeh R, Netland PA, Richards DW, et al. A clinical study of the Ahmed glaucoma valve implant in advanced glaucoma. Ophthalmology. 1998;105(10):1968-76.

88 Huang MC, Netland PA, Coleman AL, Siegner SW, Moster MR, Hill RA. Intermediate-term clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1999;127(1):27-33.

89 Minckler DS, Heuer DK, Hasty B, Baerveldt G, Cutting RC, Barlow WE. Clinical experience with the single-plate Molteno implant in complicated glaucomas. Ophthalmology. 1988;95(9):1181-8.
-9090 Valimaki J. Surgical management of glaucoma with Molteno3 implant. J Glaucoma. 2012;21(1):7-11.) The occurrence of hemorrhagic CD after these surgeries ranged from 0% to 8%, with a larger number of cases requiring surgery for fluid drainage from the suprachoroidal space.(77 Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC, et al. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012;153(5):804-14 e1., 1717 Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011;118(3):443-52., 2222 Lloyd MA, Baerveldt G, Fellenbaum PS, Sidoti PA, Minckler DS, Martone JF, et al. Intermediate-term results of a randomized clinical trial of the 350- versus the 500-mm2 Baerveldt implant. Ophthalmology. 1994;101(8):1456-63; discussion 63-4., 2626 Coleman AL, Hill R, Wilson MR, Choplin N, Kotas-Neumann R, Tam M, et al. Initial clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1995;120(1):23-31., 4343 Heuer DK, Lloyd MA, Abrams DA, Baerveldt G, Minckler DS, Lee MB, et al. Which is better? One or two? A randomized clinical trial of single-plate versus double-plate Molteno implantation for glaucomas in aphakia and pseudophakia. Ophthalmology. 1992;99(10):1512-9., 6565 Syed HM, Law SK, Nam SH, Li G, Caprioli J, Coleman A. Baerveldt-350 implant versus Ahmed valve for refractory glaucoma: a case-controlled comparison. J Glaucoma. 2004;13(1):38-45., 8787 Ayyala RS, Zurakowski D, Smith JA, Monshizadeh R, Netland PA, Richards DW, et al. A clinical study of the Ahmed glaucoma valve implant in advanced glaucoma. Ophthalmology. 1998;105(10):1968-76.

88 Huang MC, Netland PA, Coleman AL, Siegner SW, Moster MR, Hill RA. Intermediate-term clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1999;127(1):27-33.

89 Minckler DS, Heuer DK, Hasty B, Baerveldt G, Cutting RC, Barlow WE. Clinical experience with the single-plate Molteno implant in complicated glaucomas. Ophthalmology. 1988;95(9):1181-8.

90 Valimaki J. Surgical management of glaucoma with Molteno3 implant. J Glaucoma. 2012;21(1):7-11.

91 Paysse E, Lee PP, Lloyd MA, Sidoti PA, Fellenbaum PS, Baerveldt G, et al. Suprachoroidal hemorrhage after Molteno implantation. J Glaucoma. 1996;5(3):170-5.
-9292 Yalvac IS, Eksioglu U, Satana B, Duman S. Long-term results of Ahmed glaucoma valve and Molteno implant in neovascular glaucoma. Eye (Lond). 2007;21(1):65-70.)

Paysse et al. retrospectively studied hemorrhagic CD in 197 patients from two clinical studies with MI and observed this complication in 6% of cases. Most cases (67%) occurred up to one day after surgery, and virtually all cases (92%) occurred up to 5 days after surgery. No case occurred during surgery. Risk factors for this complication comprised the magnitude of IOP reduction after surgery; hypotony in the postoperative period; longer time with hypotony in the postoperative period; closed-angle glaucoma; and having been submitted to more than two previous surgeries.(9191 Paysse E, Lee PP, Lloyd MA, Sidoti PA, Fellenbaum PS, Baerveldt G, et al. Suprachoroidal hemorrhage after Molteno implantation. J Glaucoma. 1996;5(3):170-5.)

Conjunctival leakage of aqueous humor

Conjunctival leakage has the potential to cause hypotony, with its consequent complications.(8585 Bailey AK, Sarkisian SR, Jr. Complications of tube implants and their management. Curr Opin Ophthalmol. 2014;25(2):148-53., 9393 Joos KM, Lavina AM, Tawansy KA, Agarwal A. Posterior repositioning of glaucoma implants for anterior segment complications. Ophthalmology. 2001;108(2):279-84.) Conjunctival leakage may be caused by erosion of the conjunctiva, which covers the GDD, and may be associated with endophthalmitis.(9494 Al-Torbak AA, Al-Shahwan S, Al-Jadaan I, Al-Hommadi A, Edward DP. Endophthalmitis associated with the Ahmed glaucoma valve implant. Br J Ophthalmol. 2005;89(4):454-8.)

Hyphema

Hyphema in the postoperative period of TRAB or GDD seems to be due to iridectomy, ocular bulb decompression or bleeding from neovascularization, and it generally has a spontaneous resolution with conservative treatment (Figure 3).(9595 Schocket SS, Lakhanpal V, Richards RD. Anterior chamber tube shunt to an encircling band in the treatment of neovascular glaucoma. Ophthalmology. 1982;89(10):1188-94., 9696 Rand AR, Dam JI KF, Freedman SF, Moroi SE, Rhee DJ. Filtering surgery. In: Rand AR, Dam JI KF, Freedman SF, Moroi SE, Rhee DJ, editors. Shields Textbook of glaucoma. 6th ed. Philadelphia: Lippincott Williams & Wilkins, Wolters Kluwer; 2011. p. 487-513.) The incidence of this complication ranges from 2% to 25.9%.(77 Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC, et al. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012;153(5):804-14 e1., 1111 Wilson MR, Mendis U, Paliwal A, Haynatzka V. Long-term follow-up of primary glaucoma surgery with Ahmed glaucoma valve implant versus trabeculectomy. Am J Ophthalmol. 2003;136(3):464-70., 1515 Molteno AC, Bevin TH, Herbison P, Husni MA. Long-term results of primary trabeculectomies and Molteno implants for primary open-angle glaucoma. Arch Ophthalmol. 2011;129(11):1444-50., 1717 Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011;118(3):443-52., 2323 Siegner SW, Netland PA, Urban RC, Jr., Williams AS, Richards DW, Latina MA, et al. Clinical experience with the Baerveldt glaucoma drainage implant. Ophthalmology. 1995;102(9):1298-307., 5353 Christakis PG, Kalenak JW, Zurakowski D, Tsai JC, Kammer JA, Harasymowycz PJ, et al. The Ahmed Versus Baerveldt study: one-year treatment outcomes. Ophthalmology. 2011;118(11):2180-9., 8787 Ayyala RS, Zurakowski D, Smith JA, Monshizadeh R, Netland PA, Richards DW, et al. A clinical study of the Ahmed glaucoma valve implant in advanced glaucoma. Ophthalmology. 1998;105(10):1968-76., 8888 Huang MC, Netland PA, Coleman AL, Siegner SW, Moster MR, Hill RA. Intermediate-term clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1999;127(1):27-33., 9090 Valimaki J. Surgical management of glaucoma with Molteno3 implant. J Glaucoma. 2012;21(1):7-11., 9292 Yalvac IS, Eksioglu U, Satana B, Duman S. Long-term results of Ahmed glaucoma valve and Molteno implant in neovascular glaucoma. Eye (Lond). 2007;21(1):65-70., 9797 Mermoud A, Salmon JF, Alexander P, Straker C, Murray AD. Molteno tube implantation for neovascular glaucoma. Long-term results and factors influencing the outcome. Ophthalmology. 1993;100(6):897-902.

98 Thompson AM, Molteno AC, Bevin TH, Herbison P. Otago glaucoma surgery outcome study: comparative results for the 175-mm2 Molteno3 and double-plate molteno implants. JAMA Ophthalmol. 2013;131(2):155-9.

99 Topouzis F, Coleman AL, Choplin N, Bethlem MM, Hill R, Yu F, et al. Follow-up of the original cohort with the Ahmed glaucoma valve implant. Am J Ophthalmol. 1999;128(2):198-204.

100 Sidoti PA, Dunphy TR, Baerveldt G, LaBree L, Minckler DS, Lee PP, et al. Experience with the Baerveldt glaucoma implant in treating neovascular glaucoma. Ophthalmology. 1995;102(7):1107-18.
-101101 Krishna R, Godfrey DG, Budenz DL, Escalona-Camaano E, Gedde SJ, Greenfield DS, et al. Intermediate-term outcomes of 350-mm(2) Baerveldt glaucoma implants. Ophthalmology. 2001;108(3):621-6.) Patients with NVG seem to face a higher risk of developing hyphema in the postoperative period.(2323 Siegner SW, Netland PA, Urban RC, Jr., Williams AS, Richards DW, Latina MA, et al. Clinical experience with the Baerveldt glaucoma drainage implant. Ophthalmology. 1995;102(9):1298-307., 8787 Ayyala RS, Zurakowski D, Smith JA, Monshizadeh R, Netland PA, Richards DW, et al. A clinical study of the Ahmed glaucoma valve implant in advanced glaucoma. Ophthalmology. 1998;105(10):1968-76., 9292 Yalvac IS, Eksioglu U, Satana B, Duman S. Long-term results of Ahmed glaucoma valve and Molteno implant in neovascular glaucoma. Eye (Lond). 2007;21(1):65-70., 9797 Mermoud A, Salmon JF, Alexander P, Straker C, Murray AD. Molteno tube implantation for neovascular glaucoma. Long-term results and factors influencing the outcome. Ophthalmology. 1993;100(6):897-902., 100100 Sidoti PA, Dunphy TR, Baerveldt G, LaBree L, Minckler DS, Lee PP, et al. Experience with the Baerveldt glaucoma implant in treating neovascular glaucoma. Ophthalmology. 1995;102(7):1107-18.)

Figure 3
Anterior segment biomicroscopy, showing hyphema.

Endothelial loss and corneal decompensation

Hypotheses to explain endothelial injuries in patients with GDD include postoperative inflammation, the presence of an intraocular foreign body, endothelial trauma associated with surgery and the tube-endothelial touch during surgery and in the postoperative period (Figure 4). In the postoperative period, the tube-endothelial touch might be intermittent, occurring during eye movements, such as eye blinking and scratching.(3838 Chaudhry M, Grover S, Baisakhiya S, Bajaj A, Bhatia MS. Artificial drainage devices for glaucoma surgery: an overview. Nepal J Ophthalmol. 2012;4(2):295-302., 102102 Arroyave CP, Scott IU, Fantes FE, Feuer WJ, Murray TG. Corneal graft survival and intraocular pressure control after penetrating keratoplasty and glaucoma drainage device implantation. Ophthalmology. 2001;108(11):1978-85.

103 Lim KS. Corneal endothelial cell damage from glaucoma drainage device materials. Cornea. 2003;22(4):352-4.
-104104 Mendrinos E, Dosso A, Sommerhalder J, Shaarawy T. Coupling of HRT II and AS-OCT to evaluate corneal endothelial cell loss and in vivo visualization of the Ahmed glaucoma valve implant. Eye (Lond). 2009;23(9):1836-44.)

Figure 4
Tube-endothelial touch. Tube (arrow) in contact with cornea. (A) Ultrasound biomicroscopy, radial cut. (B) Ultrasound biomicroscopy, transversal cut through arrowheads in A. (C) Anterior segment biomicroscopy of another eye, also showing tube-endothelial touch (arrow).

A new surgery is recommended for tube repositioning, in case a tube-endothelial touch is detected, at risk of corneal decompensation.(3838 Chaudhry M, Grover S, Baisakhiya S, Bajaj A, Bhatia MS. Artificial drainage devices for glaucoma surgery: an overview. Nepal J Ophthalmol. 2012;4(2):295-302., 102102 Arroyave CP, Scott IU, Fantes FE, Feuer WJ, Murray TG. Corneal graft survival and intraocular pressure control after penetrating keratoplasty and glaucoma drainage device implantation. Ophthalmology. 2001;108(11):1978-85.) In children, the tip of the tube may change its position over time, therefore, a tube-endothelial touch may occur. This is likely to occur because of eye growth. According to Budenz et al., less experienced surgeons (less than 20 surgeries with GDD) were more likely to have tube-endothelial touch as complication.(1717 Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011;118(3):443-52.) Pars plana tube insertion into the vitreous cavity, after a complete PPV, has the advantage of preventing the tube-endothelial touch and of reducing endothelial trauma at the moment of the GDD surgery.(105105 Sidoti PA, Mosny AY, Ritterband DC, Seedor JA. Pars plana tube insertion of glaucoma drainage implants and penetrating keratoplasty in patients with coexisting glaucoma and corneal disease. Ophthalmology. 2001;108(6):1050-8.)

McDonnell et al. suggested the presence of GDD may rupture the blood-aqueous barrier, which would lead to intraocular inflammation and corneal graft rejection.(106106 McDonnell PJ, Robin JB, Schanzlin DJ, Minckler D, Baerveldt G, Smith RE, et al. Molteno implant for control of glaucoma in eyes after penetrating keratoplasty. Ophthalmology. 1988;95(3):364-9.) Other situations that occurred prior to GDD implantation may have caused endothelial damage, with subsequent corneal decompensation in the postoperative period, such as: previous surgeries, inflammatory processes, acute or intermittent episodes of very elevated IOP. Thus, the state of the endothelium itself prior to surgery with GDD might explain the occurrence of corneal decompensation, which would be a mere reflection of the natural course of the disease, reducing the implant influence as the factor causing the problem.(3737 Hong CH, Arosemena A, Zurakowski D, Ayyala RS. Glaucoma drainage devices: a systematic literature review and current controversies. Surv Ophthalmol. 2005;50(1):48-60., 104104 Mendrinos E, Dosso A, Sommerhalder J, Shaarawy T. Coupling of HRT II and AS-OCT to evaluate corneal endothelial cell loss and in vivo visualization of the Ahmed glaucoma valve implant. Eye (Lond). 2009;23(9):1836-44., 107107 Svedbergh B. Effects of artificial intraocular pressure elevation on the corneal endothelium in the vervet monkey (Cercopithecus ethiops). Acta Ophthalmol (Copenh). 1975;53(6):839-55.

108 Mortensen AC, Sperling S. Human corneal endothelial cell density after an in vitro imitation of elevated intraocular pressure. Acta Ophthalmol (Copenh). 1982;60(3):475-9.
-109109 Olsen T. The endothelial cell damage in acute glaucoma. On the corneal thickness response to intraocular pressure. Acta Ophthalmol (Copenh). 1980;58(2):257-66.) Some studies evaluated the endothelium of patients submitted to surgery with GDD, in which endothelial cell loss was found to be more rapid in these patients, particularly in the site surrounding the silicone tube.(110110 Kim CS, Yim JH, Lee EK, Lee NH. Changes in corneal endothelial cell density and morphology after Ahmed glaucoma valve implantation during the first year of follow up. Clin Experiment Ophthalmol. 2008;36(2):142-7.

111 Lee EK, Yun YJ, Lee JE, Yim JH, Kim CS. Changes in corneal endothelial cells after Ahmed glaucoma valve implantation: 2-year follow-up. Am J Ophthalmol. 2009;148(3):361-7.
-112112 Kim KN, Lee SB, Lee YH, Lee JJ, Lim HB, Kim CS. Changes in corneal endothelial cell density and the cumulative risk of corneal decompensation after Ahmed glaucoma valve implantation. Br J Ophthalmol. 2015.)

Exposure of drainage device

Glaucoma drainage device implantation involves risks to the patients, as it is a foreign body attached to the surface of the eye.(113113 Levinson JD, Giangiacomo AL, Beck AD, Pruett PB, Superak HM, Lynn MJ, et al. Glaucoma drainage devices: risk of exposure and infection. Am J Ophthalmol. 2015;160(3):516-21 e2.) Exposure of tube or plate is a serious complication, which may require the GDD removal, because of its high risk of causing endophthalmitis.(5454 Huddleston SM, Feldman RM, Budenz DL, Bell NP, Lee DA, Chuang AZ, et al. Aqueous shunt exposure: a retrospective review of repair outcome. J Glaucoma. 2013;22(6):433-8., 113113 Levinson JD, Giangiacomo AL, Beck AD, Pruett PB, Superak HM, Lynn MJ, et al. Glaucoma drainage devices: risk of exposure and infection. Am J Ophthalmol. 2015;160(3):516-21 e2.

114 Geffen N, Buys YM, Smith M, Anraku A, Alasbali T, Rachmiel R, et al. Conjunctival complications related to Ahmed glaucoma valve insertion. J Glaucoma. 2014;23(2):109-14.

115 Gedde SJ, Scott IU, Tabandeh H, Luu KK, Budenz DL, Greenfield DS, et al. Late endophthalmitis associated with glaucoma drainage implants. Ophthalmology. 2001;108(7):1323-7.
-116116 Heuer DK, Budenz D, Coleman A. Aqueous shunt tube erosion. J Glaucoma. 2001;10(6):493-6.). It is also important to consider leakage, which cause hypotony and shallow anterior chamber, with consequent tube-endothelial touch.(9393 Joos KM, Lavina AM, Tawansy KA, Agarwal A. Posterior repositioning of glaucoma implants for anterior segment complications. Ophthalmology. 2001;108(2):279-84.) The silicone tube, which lies on the sclera, is covered with a graft (sclera, cornea, dura mater, fascia lata or pericardium) to prevent conjunctival erosion.(5454 Huddleston SM, Feldman RM, Budenz DL, Bell NP, Lee DA, Chuang AZ, et al. Aqueous shunt exposure: a retrospective review of repair outcome. J Glaucoma. 2013;22(6):433-8., 8585 Bailey AK, Sarkisian SR, Jr. Complications of tube implants and their management. Curr Opin Ophthalmol. 2014;25(2):148-53., 113113 Levinson JD, Giangiacomo AL, Beck AD, Pruett PB, Superak HM, Lynn MJ, et al. Glaucoma drainage devices: risk of exposure and infection. Am J Ophthalmol. 2015;160(3):516-21 e2.

114 Geffen N, Buys YM, Smith M, Anraku A, Alasbali T, Rachmiel R, et al. Conjunctival complications related to Ahmed glaucoma valve insertion. J Glaucoma. 2014;23(2):109-14.

115 Gedde SJ, Scott IU, Tabandeh H, Luu KK, Budenz DL, Greenfield DS, et al. Late endophthalmitis associated with glaucoma drainage implants. Ophthalmology. 2001;108(7):1323-7.
-116116 Heuer DK, Budenz D, Coleman A. Aqueous shunt tube erosion. J Glaucoma. 2001;10(6):493-6.) The exposure may be of the silicone tube, which is more frequent, or of the plate, located in the equator of the eye (Figure 5).(5454 Huddleston SM, Feldman RM, Budenz DL, Bell NP, Lee DA, Chuang AZ, et al. Aqueous shunt exposure: a retrospective review of repair outcome. J Glaucoma. 2013;22(6):433-8., 113113 Levinson JD, Giangiacomo AL, Beck AD, Pruett PB, Superak HM, Lynn MJ, et al. Glaucoma drainage devices: risk of exposure and infection. Am J Ophthalmol. 2015;160(3):516-21 e2.) Possible causes for erosion would be immune-mediated inflammation, poor tissue perfusion with conjunctival ischemia, excessive tissue tension, and mechanical eyelid trauma on the conjunctiva that covers the implant.(5454 Huddleston SM, Feldman RM, Budenz DL, Bell NP, Lee DA, Chuang AZ, et al. Aqueous shunt exposure: a retrospective review of repair outcome. J Glaucoma. 2013;22(6):433-8., 116116 Heuer DK, Budenz D, Coleman A. Aqueous shunt tube erosion. J Glaucoma. 2001;10(6):493-6.

117 Pakravan M, Yazdani S, Shahabi C, Yaseri M. Superior versus inferior Ahmed glaucoma valve implantation. Ophthalmology. 2009;116(2):208-13.
-118118 Trubnik V, Zangalli C, Moster MR, Chia T, Ali M, Martinez P, et al. Evaluation of Risk Factors for Glaucoma Drainage Device-related Erosions: A Retrospective Case-Control Study. J Glaucoma. 2015;24(7):498-502.)

Figure 5
Conjunctival erosion, exposing: (A) patch graft: G; (B) silicone tube (arrow); (C) plate: P.

Two studies identified different risk factors, such as black race, number of topical ocular hypotensive medications before surgery with GDD; previous glaucoma laser surgery; and GDD surgery combined with another procedure at the same surgical time.

A meta-analysis analyzed 38 studies (total of 3,255 patients) and showed an incidence of exposure ranging from 0% to 12% (mean of 2.0±2.6%), and a mean follow-up of 26.1±3.3 months. Follow-up time was the main risk factor, suggesting patients should be examined periodically.(119119 Stewart WC, Kristoffersen CJ, Demos CM, Fsadni MG, Stewart JA. Incidence of conjunctival exposure following drainage device implantation in patients with glaucoma. Eur J Ophthalmol. 2010;20(1):124-30.)

As for the site of GDD plate attachment, studies focused on the upper quadrants, particularly the upper temporal.(117117 Pakravan M, Yazdani S, Shahabi C, Yaseri M. Superior versus inferior Ahmed glaucoma valve implantation. Ophthalmology. 2009;116(2):208-13., 120120 Rachmiel R, Trope GE, Buys YM, Flanagan JG, Chipman ML. Intermediate-term outcome and success of superior versus inferior Ahmed Glaucoma Valve implantation. J Glaucoma. 2008;17(7):584-90.

121 Sidoti PA. Inferonasal placement of aqueous shunts. J Glaucoma. 2004;13(6):520-3.
-122122 Martino AZ, Iverson S, Feuer WJ, Greenfield DS. Surgical outcomes of superior versus inferior glaucoma drainage device implantation. J Glaucoma. 2015;24(1):32-6.) Pakravan et al. reported that the group of patients with devices placed inferiorly had a greater incidence of extrusion, endophthalmitis and worse esthetic outcome, since the implant is more visible.(117117 Pakravan M, Yazdani S, Shahabi C, Yaseri M. Superior versus inferior Ahmed glaucoma valve implantation. Ophthalmology. 2009;116(2):208-13.) Levinson et al. have shown that patients submitted to lower tube implantation were more likely to have exposure than those whose implant was placed superiorly (12.8% versus 5.8%; p=0.056). They compared the incidence of endophthalmitis in cases of exposure of devices implanted inferiorly (41.7%) to those implanted superiorly (8.1%) with a statistically significant difference, probably due to the larger contact area between these exposed lower implants and the lacrimal fluid, rich in bacteria.(113113 Levinson JD, Giangiacomo AL, Beck AD, Pruett PB, Superak HM, Lynn MJ, et al. Glaucoma drainage devices: risk of exposure and infection. Am J Ophthalmol. 2015;160(3):516-21 e2.)

Endophthalmitis

Endophthalmitis is a serious complication that may cause a reduction of VA, which may lead to a complete loss of vision and atrophy of the eyeball. The exposure of the implant is the greatest risk factor for endophthalmitis, since the exposed GDD is a site of bacterial infection that may penetrate into the eye. Early endophthalmitis (before 1 month) may be caused by perioperative inoculation of conjunctival bacterial flora, whereas late endophthalmitis (after the first month) is virtually always caused by the exposure of the device. Gedde et al. suggested a surgical review should always be carried out in all cases of GDD exposure. The implant should be removed in virtually all cases, since the foreign body would serve as a means for bacteria to lodge and reinfect the eye after treatment with antibiotics.(115115 Gedde SJ, Scott IU, Tabandeh H, Luu KK, Budenz DL, Greenfield DS, et al. Late endophthalmitis associated with glaucoma drainage implants. Ophthalmology. 2001;108(7):1323-7.)

Studying the incidence of endophthalmitis and blebitis, Gedde et al. prospectively compared BGI versus TRAB for five years and found these complications in one case (1%) of BGI and in five cases (5%) of TRAB. Although this difference has not been statistically different, it still raises concern.(77 Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC, et al. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012;153(5):804-14 e1.)

Budenz et al. conducted a prospective study with patients submitted to surgery with AGV and with BGI, with a 1-year follow-up. Only one case of endophthalmitis was reported in the BGI group, which occurred in the first 3 months.(1717 Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011;118(3):443-52.) In this cohort, there was no case of endophthalmitis in a 5-year postoperative period; hence it raised the hypothesis late endophthalmitis should not be of concern in cases of GDD, in contrast with those of TRAB.(123123 Budenz DL, Feuer WJ, Barton K, Schiffman J, Costa VP, Godfrey DG, et al. Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up. Am J Ophthalmol. 2016;163:75-82 e3.)

Retinal detachment

Retinal detachment (RD) is an important cause of visual loss, and if not treated, it virtually always progresses to blindness.(124124 Wilkinson CP. Rhegmatogenous Retinal Detachment. In: Yanoff M, Duker JS, editors. Ophthalmology. 1. 3rd ed: Mosby Elsevier; 2009. p. 720-6.) In addition to blindness, RD may cause phthisis bulbi.(125125 Schmack I, Völcker HE, Grossniklaus HE. Phthisis bulbi. In: Levin LA, Albert DM, editors. Ocular Disease: Mechanisms and Management. 1st ed. United States of America: Sauders Elsevier; 2010. p. 415-23.)

Waterhouse et al. carried out a survey on 350 patients submitted to antiglaucoma surgeries with MI. Sixteen patients (5%) were identified with RD. Out of these 16 patients, six (38%) developed phthisis bulbi, and one patient had to undergo enucleation. There is not just one mechanism explaining the origin of RD in these patients, since some of them had been submitted to other previous ocular surgeries, including PPV, ocular trauma repair, TRAB, PK, and lensectomy. They demonstrated the most frequent cause of retinal tears (origin of retinal detachment) is through the posterior vitreous detachment. Some patients had conditions in which the vitreous was abnormally adhered to the retina, which might cause tears (one case of lattice degeneration and one case with chorioretinal scar by a chronic uveitis condition). Only one patient was phakic (the others were aphakic or pseudophakic). The possibility that the GDD surgery has caused the retinal tears has not been excluded. In one of the cases, there was a vitreous obstruction of the tip of the tube situated in the pars plana. In this patient, peripheral retinal tears were in the same quadrant of the retina in which the tube was located.(126126 Waterhouse WJ, Lloyd MA, Dugel PU, Heuer DK, Baerveldt G, Minckler DS, et al. Rhegmatogenous retinal detachment after Molteno glaucoma implant surgery. Ophthalmology. 1994;101(4):665-71.) Patients submitted to previous PPV may progress to RD, even after months, since iatrogenic retinal tears may occur in this procedure by vitreoretinal traction exerted by instruments in the sclera entry sites.(127127 Carter JB, Michels RG, Glaser BM, De Bustros S. Iatrogenic retinal breaks complicating pars plana vitrectomy. Ophthalmology. 1990;97(7):848-53; discussion 54.) Patients submitted to cataract surgery also face a high risk of posterior vitreous detachment, with consequent formation of retinal tears, which may cause RD.(128128 Lois N, Wong D. Pseudophakic retinal detachment. Surv Ophthalmol. 2003;48(5):467-87.) In other studies, the incidence of RD ranged from 0% to 10%.(77 Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC, et al. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012;153(5):804-14 e1., 2222 Lloyd MA, Baerveldt G, Fellenbaum PS, Sidoti PA, Minckler DS, Martone JF, et al. Intermediate-term results of a randomized clinical trial of the 350- versus the 500-mm2 Baerveldt implant. Ophthalmology. 1994;101(8):1456-63; discussion 63-4., 4444 Britt MT, LaBree LD, Lloyd MA, Minckler DS, Heuer DK, Baerveldt G, et al. Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? Ophthalmology. 1999;106(12):2312-8., 8888 Huang MC, Netland PA, Coleman AL, Siegner SW, Moster MR, Hill RA. Intermediate-term clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1999;127(1):27-33., 9090 Valimaki J. Surgical management of glaucoma with Molteno3 implant. J Glaucoma. 2012;21(1):7-11.) These studies had different designs, follow-up periods, and populations.

Phthisis bulbi

It occurs as the final stage of the severe eye disease and is characterized by soft eye (hypotony) with a limited size, containing atrophic and disorganized internal structures.(129129 Tan LT, Isa H, Lightman S, Taylor SR. Prevalence and causes of phthisis bulbi in a uveitis clinic. Acta Ophthalmol. 2012;90(5):e417-8., 130130 Hogan MJ, Zimmerman LE. Diffuse Ocular Desease and Its Sequelae. In: Hogan MJ, Zimmerman LE, editors. Ophthalmic Pathology: An Atlas and Textbook. 2nd ed. United States of America: W. B. Saunders Company; 1971. p. 132-5.)

Studies have reported the incidence of phthisis bulbi ranging from 0% to 18% in patients submitted to surgery with GDD, with RD and NVG being the most common causes, and patients with NVG having the highest incidence of this complication.(2323 Siegner SW, Netland PA, Urban RC, Jr., Williams AS, Richards DW, Latina MA, et al. Clinical experience with the Baerveldt glaucoma drainage implant. Ophthalmology. 1995;102(9):1298-307., 4343 Heuer DK, Lloyd MA, Abrams DA, Baerveldt G, Minckler DS, Lee MB, et al. Which is better? One or two? A randomized clinical trial of single-plate versus double-plate Molteno implantation for glaucomas in aphakia and pseudophakia. Ophthalmology. 1992;99(10):1512-9., 4545 Mills RP, Reynolds A, Emond MJ, Barlow WE, Leen MM. Long-term survival of Molteno glaucoma drainage devices. Ophthalmology. 1996;103(2):299-305., 4646 Allan EJ, Khaimi MA, Jones JM, Ding K, Skuta GL. Long-term efficacy of the Baerveldt 250 mm2 compared with the Baerveldt 350 mm2 implant. Ophthalmology. 2015;122(3):486-93., 8888 Huang MC, Netland PA, Coleman AL, Siegner SW, Moster MR, Hill RA. Intermediate-term clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1999;127(1):27-33.

89 Minckler DS, Heuer DK, Hasty B, Baerveldt G, Cutting RC, Barlow WE. Clinical experience with the single-plate Molteno implant in complicated glaucomas. Ophthalmology. 1988;95(9):1181-8.
-9090 Valimaki J. Surgical management of glaucoma with Molteno3 implant. J Glaucoma. 2012;21(1):7-11., 9797 Mermoud A, Salmon JF, Alexander P, Straker C, Murray AD. Molteno tube implantation for neovascular glaucoma. Long-term results and factors influencing the outcome. Ophthalmology. 1993;100(6):897-902., 9999 Topouzis F, Coleman AL, Choplin N, Bethlem MM, Hill R, Yu F, et al. Follow-up of the original cohort with the Ahmed glaucoma valve implant. Am J Ophthalmol. 1999;128(2):198-204.

100 Sidoti PA, Dunphy TR, Baerveldt G, LaBree L, Minckler DS, Lee PP, et al. Experience with the Baerveldt glaucoma implant in treating neovascular glaucoma. Ophthalmology. 1995;102(7):1107-18.
-101101 Krishna R, Godfrey DG, Budenz DL, Escalona-Camaano E, Gedde SJ, Greenfield DS, et al. Intermediate-term outcomes of 350-mm(2) Baerveldt glaucoma implants. Ophthalmology. 2001;108(3):621-6., 131131 Barton K, Feuer WJ, Budenz DL, Schiffman J, Costa VP, Godfrey DG, et al. Three-year treatment outcomes in the Ahmed Baerveldt comparison study. Ophthalmology. 2014;121(8):1547-57 e1., 132132 Lloyd MA, Sedlak T, Heuer DK, Minckler DS, Baerveldt G, Lee MB, et al. Clinical experience with the single-plate Molteno implant in complicated glaucomas. Update of a pilot study. Ophthalmology. 1992;99(5):679-87.)

Strabismus

Shwartz et al. reported that transient strabismus is not rare after GDD surgery and it usually improves with reduction of the edema of periocular tissues. These authors also informed BGI is more likely to cause strabismus and, for this reason, its manufacturer interrupted the production of the largest model, whose plate had an area of 500 mm2. Another change was the addition of plate fenestrations, allowing for the growth of fibrous bands, which reduced the height of FB, and that might have reduced the incidence of this complication.(1818 Schwartz KS, Lee RK, Gedde SJ. Glaucoma drainage implants: a critical comparison of types. Curr Opin Ophthalmol. 2006;17(2):181-9.) Rauscher et al. reported that in patients submitted to BGI surgery, the incidences of persistent strabismus ranged from 2.1% to 77%, and of diplopia, from 1.4% to 37%.(133133 Rauscher FM, Gedde SJ, Schiffman JC, Feuer WJ, Barton K, Lee RK, et al. Motility disturbances in the tube versus trabeculectomy study during the first year of follow-up. Am J Ophthalmol. 2009;147(3):458-66.) Hong et al. found a higher incidence of diplopia in the group of BGI (9%), when compared to AGV (3%) and MI (2%) (p<0.01). These authors suggested this higher incidence of ocular motility disorders in BGI would have occurred by the fact that its sides were implanted below two rectus muscles, causing local fibrosis and imbalance of extraocular muscles. There is a hypothesis that higher FB may cause strabismus in all models of GDD and that the higher the FB, the higher the chance of this complication to occur. Since BGI is the largest among all models, it would be more likely to have a very high FB, which would also explain a greater occurrence of disorders of extrinsic ocular motility. They have found the incidence of diplopia between 6% and 18%, excluding only one work in which the incidence was 77%.(3737 Hong CH, Arosemena A, Zurakowski D, Ayyala RS. Glaucoma drainage devices: a systematic literature review and current controversies. Surv Ophthalmol. 2005;50(1):48-60.) In other studies, the incidence of strabismus ranged from 0% to 27%.(77 Gedde SJ, Herndon LW, Brandt JD, Budenz DL, Feuer WJ, Schiffman JC, et al. Postoperative complications in the Tube Versus Trabeculectomy (TVT) study during five years of follow-up. Am J Ophthalmol. 2012;153(5):804-14 e1., 1414 Panarelli JF, Banitt MR, Gedde SJ, Shi W, Schiffman JC, Feuer WJ. A Retrospective Comparison of Primary Baerveldt Implantation versus Trabeculectomy with Mitomycin C. Ophthalmology. 2016;123(4):789-95., 2323 Siegner SW, Netland PA, Urban RC, Jr., Williams AS, Richards DW, Latina MA, et al. Clinical experience with the Baerveldt glaucoma drainage implant. Ophthalmology. 1995;102(9):1298-307., 2626 Coleman AL, Hill R, Wilson MR, Choplin N, Kotas-Neumann R, Tam M, et al. Initial clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1995;120(1):23-31., 5353 Christakis PG, Kalenak JW, Zurakowski D, Tsai JC, Kammer JA, Harasymowycz PJ, et al. The Ahmed Versus Baerveldt study: one-year treatment outcomes. Ophthalmology. 2011;118(11):2180-9., 8787 Ayyala RS, Zurakowski D, Smith JA, Monshizadeh R, Netland PA, Richards DW, et al. A clinical study of the Ahmed glaucoma valve implant in advanced glaucoma. Ophthalmology. 1998;105(10):1968-76., 9292 Yalvac IS, Eksioglu U, Satana B, Duman S. Long-term results of Ahmed glaucoma valve and Molteno implant in neovascular glaucoma. Eye (Lond). 2007;21(1):65-70., 101101 Krishna R, Godfrey DG, Budenz DL, Escalona-Camaano E, Gedde SJ, Greenfield DS, et al. Intermediate-term outcomes of 350-mm(2) Baerveldt glaucoma implants. Ophthalmology. 2001;108(3):621-6., 117117 Pakravan M, Yazdani S, Shahabi C, Yaseri M. Superior versus inferior Ahmed glaucoma valve implantation. Ophthalmology. 2009;116(2):208-13., 133133 Rauscher FM, Gedde SJ, Schiffman JC, Feuer WJ, Barton K, Lee RK, et al. Motility disturbances in the tube versus trabeculectomy study during the first year of follow-up. Am J Ophthalmol. 2009;147(3):458-66., 134134 Nassiri N, Kamali G, Rahnavardi M, Mohammadi B, Nassiri S, Rahmani L, et al. Ahmed glaucoma valve and single-plate Molteno implants in treatment of refractory glaucoma: a comparative study. Am J Ophthalmol. 2010;149(6):893-902.)

Some studies have evaluated particularly strabismus after GDD, and the following disorders were described: paresis of the superior oblique muscle, acquired Brown syndrome (pseudo-Brown syndrome), exotropia, general restriction of the upward gaze, or another movement limitation of the quadrant where the device is implanted.(2424 Smith SL, Starita RJ, Fellman RL, Lynn JR. Early clinical experience with the Baerveldt 350-mm2 glaucoma implant and associated extraocular muscle imbalance. Ophthalmology. 1993;100(6):914-8., 135135 Dobler-Dixon AA, Cantor LB, Sondhi N, Ku WS, Hoop J. Prospective evaluation of extraocular motility following double-plate molteno implantation. Arch Ophthalmol. 1999;117(9):1155-60.)

Reduction of visual acuity

The review work conducted by Hong et al. did not find any difference in the reduction of VA, of at least two lines, among different GDD (p=0.90). Mean number of patients who had loss of VA was 33% for single-plate MI, 28% for double-plate MI, 27% for BGI, and 24% for AGV.(3737 Hong CH, Arosemena A, Zurakowski D, Ayyala RS. Glaucoma drainage devices: a systematic literature review and current controversies. Surv Ophthalmol. 2005;50(1):48-60.)

Some studies have reported VA similar to (the same or with a difference of one line) or better than that of the preoperative period in 46% to 82% of patients. The worsening of VA, of two or more lines, was reported in 18% to 54% of patients.(1717 Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011;118(3):443-52., 4343 Heuer DK, Lloyd MA, Abrams DA, Baerveldt G, Minckler DS, Lee MB, et al. Which is better? One or two? A randomized clinical trial of single-plate versus double-plate Molteno implantation for glaucomas in aphakia and pseudophakia. Ophthalmology. 1992;99(10):1512-9., 4444 Britt MT, LaBree LD, Lloyd MA, Minckler DS, Heuer DK, Baerveldt G, et al. Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? Ophthalmology. 1999;106(12):2312-8., 8888 Huang MC, Netland PA, Coleman AL, Siegner SW, Moster MR, Hill RA. Intermediate-term clinical experience with the Ahmed Glaucoma Valve implant. Am J Ophthalmol. 1999;127(1):27-33., 9292 Yalvac IS, Eksioglu U, Satana B, Duman S. Long-term results of Ahmed glaucoma valve and Molteno implant in neovascular glaucoma. Eye (Lond). 2007;21(1):65-70., 136136 Gedde SJ, Schiffman JC, Feuer WJ, Herndon LW, Brandt JD, Budenz DL, et al. Three-year follow-up of the tube versus trabeculectomy study. Am J Ophthalmol. 2009;148(5):670-84.) The worsening of VA may occur by progression of glaucoma and/or of other associated diseases, or by complications of GDD.(1717 Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011;118(3):443-52., 4444 Britt MT, LaBree LD, Lloyd MA, Minckler DS, Heuer DK, Baerveldt G, et al. Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? Ophthalmology. 1999;106(12):2312-8., 101101 Krishna R, Godfrey DG, Budenz DL, Escalona-Camaano E, Gedde SJ, Greenfield DS, et al. Intermediate-term outcomes of 350-mm(2) Baerveldt glaucoma implants. Ophthalmology. 2001;108(3):621-6.) It is emphasized these studies had differences in follow-up period, design and populations. Patients with NVG had higher rates of loss of VA and of light perception, probably due to glaucoma progression and the ischemic retinal disease that caused glaucoma.(1717 Budenz DL, Barton K, Feuer WJ, Schiffman J, Costa VP, Godfrey DG, et al. Treatment outcomes in the Ahmed Baerveldt Comparison Study after 1 year of follow-up. Ophthalmology. 2011;118(3):443-52., 101101 Krishna R, Godfrey DG, Budenz DL, Escalona-Camaano E, Gedde SJ, Greenfield DS, et al. Intermediate-term outcomes of 350-mm(2) Baerveldt glaucoma implants. Ophthalmology. 2001;108(3):621-6.)

DISCUSSION AND CONCLUSIONS

Glaucoma drainage implants are helpful in managing refractory glaucoma. They have been used more frequently and the results of scientific studies have proved its efficacy and safety are comparable with those of TRAB, being the preferred choice in cases of high risk of failure of standard surgery. These afore-mentioned trends toward increasing use of GDD, as well as toward choosing GDD as the first surgical option, reflect data mainly from the United States, and may not be the same in other countries, especially in developing countries, because of cost issues. Perhaps, economic reimbursement factors may also influence this trend. It is important to highlight that TRAB is a very important and established first option surgery and, in case of its failure, GDD could be performed. But, the inversion of this surgical sequence raises concern, because, after a GDD implantation, it would not make sense to “go back” to a TRAB. In addition, TRAB is no more possible in the same quadrant of the implanted GDD. The PTVT study supports TRAB as the first surgical option for uncomplicated open-angle glaucoma patients who had not undergone previous incisional ocular surgery, providing a better IOP control.

New designs of the traditional GDD should be tested to improve long-term IOP control and reduce complications, mainly those related to corneal endothelial cell loss, hypotony and exposure of device. The recent Molteno3® and Susanna implants have much thinner plates, when compared to traditional AGV and BGI. These thinner plates may reduce conjunctival complications and make the surgery easier. In the future, new biomaterials and better wound healing modulation may improve IOP results.

There is a trend toward non-bleb-formation procedures, probably trying to avoid bleb complications and making the surgery less invasive, with easier technique (minimally invasive glaucoma surgeries). So far, minimally invasive glaucoma surgeries have been indicated only in initial or moderate glaucoma, since their IOP reduction is limited. Therefore, for undetermined period, GDD will have their role in challenging cases and should not be compared with minimally invasive glaucoma surgery devices.

  • Institution: Hospital São Geraldo – Universidade Federal de Minas Gerais.
  • Financial support: the authors received no financial support for this work.

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Publication Dates

  • Publication in this collection
    06 June 2022
  • Date of issue
    2022

History

  • Received
    29 Apr 2021
  • Accepted
    07 July 2021
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