Contact Lens, Contact Lens Discomfort, Questionnaire
Conditions
Keywords
the 8-item Contact Lens Dry Eye Questionnaire, CLDEQ-8, Contact Lens Discomfort, Questionnaire, Chinese translation and validation
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.
Detailed 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.
Interventions
None listed
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The reliability of the C-CLDEQ-8 | 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
| Measure | Time frame | Description |
|---|---|---|
| The repeatability of the C-CLDEQ-8 | 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. |
| Cutoff score for C-CLDEQ-8 to predict Excellent/Very Good overall of SCLs. | 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. |
Countries
China
Outcome results
None listed