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

NCT ID: NCT05416528

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-18

Study Completion Date

2023-04-22

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.

Conditions

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Contact Lens Questionnaire Contact Lens Discomfort

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Xiao Yang

Professor Xiao Yang, M.D, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2022KYPJ100

Identifier Type: -

Identifier Source: org_study_id