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

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05416528

Collaborator

(none)

134

Enrollment

Location

Anticipated Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Questionnaire Contact Lens Discomfort

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

134 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 20, 2022

Anticipated Study Completion Date :

Dec 30, 2023

Outcome Measures

Primary Outcome Measures

The reliability of the C-CLDEQ-8 [before the ocular examination]
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.

Secondary Outcome Measures

The repeatability of the C-CLDEQ-8 [before and after the ocular examination on the same day of visit]
a subgroup of 50 participants are asked to complete C-CLDEQ-8 twice. Correlation coefficient between the two scores of the first and second questionnaire evaluation is used to evaluate the repeatability.
Cutoff score for C-CLDEQ-8 to predict "Excellent/Very Good" overall of SCLs. [before the ocular examination]
The Youden-index method is used to determine the cutoff value of the C-CLDEQ-8 score that maximized sensitivity+specificity -1.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.