Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) Among Chinese Soft Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- The reliability of the C-CLDEQ-8
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The reliability of the C-CLDEQ-8
时间窗: 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.
次要结局
- The repeatability of the C-CLDEQ-8(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.(before the ocular examination)
研究者
Xiao Yang
Professor Xiao Yang, M.D, PhD
Zhongshan Ophthalmic Center, Sun Yat-sen University