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

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

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.

Study Overview

• Status: Completed
• Conditions: Contact Lens Discomfort; Questionnaire; Contact Lens

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 Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The subjects are residents of Guangzhou, China.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Actual): November 18, 2022
• Study Completion (Actual): April 22, 2023

Study Registration Dates

• First Submitted: June 8, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Questionnaire; Contact Lens Discomfort; the 8-item Contact Lens Dry Eye Questionnaire; CLDEQ-8; Chinese translation and validation
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: 2022KYPJ100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No