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

Sun Yat-sen University logo

Sun Yat-sen University

Status

Completed

Conditions

Questionnaire
Contact Lens Discomfort
Contact Lens

Study type

Observational

Funder types

Other

Identifiers

NCT05416528
2022KYPJ100

Details and patient eligibility

About

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.

Full 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.

Enrollment

134 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.
  1. Having congenital or systemic conditions that would limit the capacity to answer the questionnaire

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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