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Completed

NCT Number: NCT05416528

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. The reliability of the C-CLDEQ-8

    Time frame: before the ocular examination

    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.

Secondary outcomes

  1. The repeatability of the C-CLDEQ-8

    Time frame: before and after the ocular examination on the same day of visit

    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.

  2. Cutoff score for C-CLDEQ-8 to predict "Excellent/Very Good" overall of SCLs.

    Time frame: before the ocular examination

    The Youden-index method is used to determine the cutoff value of the C-CLDEQ-8 score that maximized sensitivity+specificity -1.

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: CLDEQ-8

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 13, 2022
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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