The contact lens dry eyes questionnaire (CLDEQ-8) validation and ocular surface dysfunction among soft contact lens wearers

Ribeiro, Marcelo; Vieira, Matheus Schmitz; Gorgone, Gabriel; Barbosa, Lucas Yunes Cominatto; Martini, Alexandre Ricardo Abdel Fattah; David, Milton Agrizzi; Fornazari, Denise Oliveira; Alves, Monica; Arieta, Carlos Eduardo Leite

doi:10.5935/0004-2749.20220015

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Original Article • Arq. Bras. Oftalmol. 85 (1) • Jan-Feb 2022 • https://doi.org/10.5935/0004-2749.20220015 copy

The contact lens dry eyes questionnaire (CLDEQ-8) validation and ocular surface dysfunction among soft contact lens wearers

Validação do questionário de olho seco em lentes de contato (CLDEQ-8) e a disfunção de superfície ocular em usuários de lente de contato

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Purpose:

To translate and validate the Contact Lens Dry Eyes Questionnaire (CLDEQ-8) to Portuguese language and to describe the impact of soft contact lenses on the ocular surface.

Methods:

We conducted a descriptive transversal study with the aim to: (1) translate and validate the CLDEQ-8 questionnaire to Portuguese language and (2) apply the CLDEQ-8 to a group of contact lens wearers along with a broad evaluation of the impact of soft contact lens on the ocular surface. The evaluation of the impact of soft contact lens was performed for a study population of 81 subjects, categorized in two groups: Group A: 61 contact lens wearers and Group B (control): 20 noncontact lens wearers. The study exclusion criteria were rigid contact lens wear, systemic or ocular diseases, the use of medications predisposing to ocular surface damage, and previous ocular surgeries.

Results:

For the CLDEQ-8 questionnaire translation and validation, Kappa agreement values were ³0.7 in all questions, implying a good agreement between the Portuguese and English language versions. Considering the ocular surface evaluation of the subjects, all parameters differed in Soft contact lens wearers when compared with the controls (p<0.05), except in those related to tear volume, such as the tear meniscus height and Schirmer test.

Conclusions:

This study provided a translated and validated Portuguese version of CLDEQ-8 questionnaire, which represents an important tool for the evolution of contact lens wearers. The broad evaluation of the ocular surface revealed an association between soft contact lens wearing and ocular surface disturbances.

Keywords:
Contact lens; Dry eye syndrome; Ocular surface; Survey and questionnaire; Reproducibility of results

Question	Kappa value	p-value
1a	0.70	<0.001
1b	0.70	<0.001
2a	0.74	<0.001
2b	0.71	<0.001
3a	0.72	<0.001
3b	0.72	<0.001
4	0.71	<0.001
5	0.70	<0.001

	Group A (n=61)	Group B (n=20)	p-value
Age (years-old)	34 (19-60)	32 (24-38)	0.53^d
Sex male/female (%)	26/74	40/60	0.05^l
Air conditioner hours/day	5.1 (0-10)	4.7 (1-8)	0.34^d
Computer display use hours/day	4.7 (0-10)	3.1 (1-8)	0.06^d
Duration of SCL wear (years)	13.1 (1-43)	-
SCL wear days/week	5.9 (2-7)	-
SCL wear hours/day	12.4 (2-24)	-

	Group A	Group B	p-value
TMH	0.29 ± 0.16	0.25 ± 0.07	0.3833^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 0.2-0.3)	(95% CI 0.2-0.3)
CH	1.29 ± 0.4	0.65 ± 0.36	0.0001^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 1.1-1.4)	(95% CI 0.4-0.8)
Bulbar temporal CH	1.49 ± 0.53	0.62 ± 0.39	0.0001^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 1.3-1.8)	(95% CI 0.4-0.8)
Bulbar nasal CH	1.44 ± 0.55	0.62 ± 0.32	0.0001^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 1.3-1.5)	(95% CI 0.4-0.7)
Limbal temporal CH	0.91 ± 0.43	0.47 ± 0.24	0.0001^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 0.7-1.0)	(95% CI 0.3-0.5)
Limbal nasal CH	0.93 ± 0.39	0.43 ± 0.18	0.0001^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 0.8-1.0)	(95% CI 0.3-0.5)
NITBUT	7.24 ± 4.02	8.44 ± 3.27	0.0032^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 6.2-8.2)	(95% CI 6.9-9.9)
Meiboscore inferior			<0.0001^l
0	10 (16.39%)	8 (40%)
1	34 (55.73%)	11 (55%)
2	12 (19.67%)	1 (5%)
3	3 (4.91%)	0 (0%)
4	2 (3.27%)	0 (0%)
Meiboscore superior			<0.0001^l
0	0 (0%)	3 (15%)
1	37 (60.65%)	16 (80%)
2	17 (27.86%)	1 (5%)
3	6 (9.83%)	0 (0%)
4	1 (1.63%)	0 (0%)
TBUT	7.70 ± 4.63	10.55 ± 3.88	0.0023^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 6.5-8.8)	(95% CI 8.7-12.3)
FCS	2.0 ± 1.77	0.40 ± 0.50	0.0001^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 1.5-2.4)	(95% CI 0.1-0.6)
Schirmer test	20.72 ± 10.9	20.05 ± 9.82	0.8086^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 17.9-23.5)	(95% CI 15.4-24.6)
LOGSS	1.80 ± 0.89	0.30 ± 0.47	0.0001^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 1.0- 2.6)	(95% CI 0.1-0.6)
OSDI	13.58 ± 12.52	1.18 ± 1.63	0.0001^d d = Mann-Whitney U-test; l= Fischer's Exact test; OSDI= Ocular Surface Disease Index; TMH= tear meniscus height; CH= conjunctival hyperemia; NITBUT= non-invasive tear break-up time; TBUT= tear break-up time; FCS= fluorescein corneal staining; LGOSS= lissamine green ocular surface staining.
	(95% CI 10.38-16.8)	(95% CI 0.4-1.9

Contact Lens Questionnaire-8 (CLDEQ-8)
Questions about EYE DISCOMFORT:
a. During a typical day in the past 2 weeks, how often did your eyes feel discomfort when wearing your contact lenses?
0 Never
1 Rarely
2 Sometimes
3 Frequently
4 Constantly
When your eyes felt discomfort with your contact lenses, how intense was this feeling of discomfort?
b. At the end of your wearing time?
	Never	Not at all	Very
	Have it	Intense	Intense
	0 1	2 3	4 5
Questions about EYE DRYNESS:
a. During a typical day in the past 2 weeks, how often did your eyes feel dry?
0 Never
1 Rarely
2 Sometimes
3 Frequently
4 Constantly
When your eyes felt dry, how intense was this feeling of dryness?
b. At the end of your wearing time?
	Never	Not at all	Very
	Have it	Intense	Intense
	0 1	2 3	4 5
Questions about CHANGEABLE, BLURRY VISION:
a. During a typical day in the past 2 weeks, how often did your vision change between clear and blurry or foggy when wearing your contact lenses?
0 Never
1 Rarely
2 Sometimes
3 Frequently
4 Constantly
When your vision was blurry, how noticeable was the changeable, blurry, or foggy vision?
b. At the end of your wearing time?
	Never	Not at all	Very
	Have it	Intense	Intense
	0 1	2 3	4 5
Contact Lens Questionnaire-8 (CLDEQ-8)
Question about CLOSING YOUR EYES:
During a typical day in the past 2 weeks, how often did your eyes bother you so much that you wanted to close them?
0 Never
1 Rarely
2 Sometimes
3 Frequently
4 Constantly
Question about REMOVING YOUR LENSES:
How often during the past 2 weeks, did your eyes bother you so much while wearing your contact lenses that you felt as if you needed to stop whatever you were doing and take out your contact lenses?
1 Never
2 Less than once a week
3 Weekly
4 Several times a week
5 Daily
6 Several times a day

Questionário de Olho Seco em Usuário de Lente de Contato
1. Questões sobre desconforto ocular
c. Durante um dia comum, nas ultimas 2 semanas, com que frequência você sentiu desconforto ocular relacionado ao uso de suas lentes de contato?
0 Nunca
1 Raramente
2 Às vezes
3 Frequentemente
4 Constantemente
d. Na ocasião em que você sentiu desconforto com suas lentes de contato, qual intensidade ao final do período de uso?
	Nunca senti	Pouco Intenso	Muito Intenso
	0 1	2 3	4 5
2. Questões sobre olho seco
c. Durante um dia comum, nas ultimas 2 semanas, com que frequência você teve sensação de olho seco?
0 Nunca
1 Raramente
2 Às vezes
3 Frequentemente
4 Constantemente
d. Na ocasião em que você teve sensação de olho seco, qual intensidade ao final do período de uso das lentes de contato?
	Nunca senti	Pouco Intenso	Muito Intenso
	0 1	2 3	4 5
3. Questões sobre embaçamento visual
c. Durante um dia comum, nas ultimas 2 semanas, com que frequência você sentiu embaçamento visual durante o uso de suas lentes de contato?
0 Nunca
1 Raramente
2 Às vezes
3 Frequentemente
4 Constantemente
d. Na ocasião em que você sentiu embaçamento visual com suas lentes de contato, qual a intensidade deste sintoma ao final do período de uso?
	Nunca senti	Pouco Intenso	Muito Intenso
	0 1	2 3	4 5
Questionário de Olho Seco em Usuário de Lente de Contato
4. Questão sobre fechamento ocular
Durante um dia comum, nas últimas 2 semanas, com que frequência você sentiu tamanho desconforto ocular ao ponto de necessitar fechar os olhos?
0 Nunca
1 Raramente
2 Às vezes
3 Frequentemente
4 Constantemente
5. Questão sobre remoção das lentes de contato
Com que frequência nas últimas 2 semanas você sentiu tamanho desconforto ocular ao ponto de interromper alguma atividade e retirar as lentes de contato?
1 Nunca
2 Menos de uma vez por semana
3 Toda semana
4 Várias vezes durante a semana
5 Diariamente
6 Várias vezes ao dia

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[1] Corresponding author: Monica Alves. E-mail: monicalves@me.com