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

Questionnaire Clinical Trial

— CLDEQ-8  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05416528
• Other study ID #: 2022KYPJ100
• Status: Completed
• Start date: November 18, 2022
• Est. completion date: April 22, 2023

Study information

• Verified date: November 2023
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 22, 2023
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age between 18-60

2. Native Chinese citizens with Chinese as first language

3. Wearing history with spherical disposable SCL (daily disposable, 2 weeks, or monthly disposable) for a least 1 months;

4. Willing to sign informed consent

Exclusion Criteria:

1. Any extended wear of SCLs, including wearing toric or multi-focal SCLs

2. Use SCL for monovision correction

3. Having clinically significant anterior segment abnormalities (including iritis and infection of the eye, lids, or ocular adnexa)

4. Having ocular or systemic disease that would preclude SCL wearing

5. Best corrected visual acuity of less than 0.8 in either eye

6. History of refractive or other types of corneal surgeries

7. 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

Related Conditions & MeSH terms

• Contact Lens
• Contact Lens Discomfort
• Dry Eye Syndromes
• Questionnaire

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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