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

NCT05416528 | Completed

• 1 other identifier: 2022KYPJ100
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Lens; Questionnaire; Contact Lens Discomfort

Keywords

the 8-item Contact Lens Dry Eye Questionnaire; CLDEQ-8; Contact Lens Discomfort; Questionnaire; Chinese translation and validation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The repeatability of the C-CLDEQ-8

  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.

  before the ocular examination

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The subjects are residents of Guangzhou, China.

You may qualify if:

• 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

You may not qualify if:

• 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.
• \) Having congenital or systemic conditions that would limit the capacity to answer the questionnaire

Sponsors & Collaborators

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

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Xiao Yang, M.D, PhD

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 13, 2022
• Study Start: November 18, 2022
• Primary Completion: November 18, 2022
• Study Completion: April 22, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

CN (1)