Chinese Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8)

Study Overview
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Brief Summary
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This is a cross-cultural adaptation, evaluation and validation study of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) among soft contact lens wearers in China.

Detailed Description
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The aim of this study is to translate the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) into Chinese and evaluate its validity, and reliability among soft contact lens wearers in China. One hundred and thirty-four Chinese soft contact lens wearers will be included in the study. Subjects are required to complete the Chinese version of the 8-item Contact Lens Dry Eye Questionnaire (C-CLDEQ-8) on paper before eye examinations. A subgroup of 50 participants will be asked to complete C-CLDEQ-8 twice to evaluate the repeatability.

Official Title
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Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) Among Chinese Soft Contact Lens Wearers

Conditions
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Contact Lens, Questionnaire, Contact Lens Discomfort

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-60 Native Chinese citizens with Chinese as first language Wearing history with spherical disposable SCL (daily disposable, 2 weeks, or monthly disposable) for a least 1 months; Willing to sign informed consent Exclusion Criteria: Any extended wear of SCLs, including wearing toric or multi-focal SCLs Use SCL for monovision correction Having clinically significant anterior segment abnormalities (including iritis and infection of the eye, lids, or ocular adnexa) Having ocular or systemic disease that would preclude SCL wearing Best corrected visual acuity of less than 0.8 in either eye History of refractive or other types of corneal surgeries Having eyelid abnormalities or functional ocular disorders that would induce relevant discomfort. 8) Having congenital or systemic conditions that would limit the capacity to answer the questionnaire

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The reliability of the C-CLDEQ-8 | Subjects are asked to complete C-CLDEQ-8. Internal consistency (reliability) of the C-CLDEQ-8 is evaluated using the Cronbach's Alpha analysis and the corrected index of homogeneity. For Cronbach´s Alpha results: < 0.5 is considered unacceptable; 0.5-0.6 poor; 0.6-0.7 questionable; 0.7-0.8 acceptable; 0.8-0.9 good; and > 0.9 excellent. | before the ocular examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The repeatability of the C-CLDEQ-8 | a subgroup of 50 participants are asked to complete C-CLDEQ-8 twice. Intraclasss correlation coefficient between the two scores of the first and second questionnaire evaluation is used to evaluate the repeatability. >0.7 is considered reliable. | before and after the ocular examination on the same day of visit | 
| Cutoff score for C-CLDEQ-8 to predict Excellent/Very Good overall of SCLs. | The Youden-index method is used to determine the cutoff value of the C-CLDEQ-8 score that maximized sensitivity+specificity -1. | before the ocular examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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the 8-item Contact Lens Dry Eye Questionnaire, CLDEQ-8, Contact Lens Discomfort, Questionnaire, Chinese translation and validation