An observational study in Contact Lens, Questionnaire and Contact Lens Discomfort, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Observational
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.
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.
Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
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The subjects are residents of Guangzhou, China.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
8) Having congenital or systemic conditions that would limit the capacity to answer the questionnaire
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.
Time frame: before the ocular examination
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.
Time frame: 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.
Time frame: before the ocular examination
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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