Psychometric Properties of the Croatian Version of the Ocular Surface Disease Index Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- OSDI translation to the Croatian language and Cro-OSDI score measurement
研究概览
简要总结
Ocular Surface Disease Index (OSDI) Questionnaire is an important tool for the diagnosis of dry eye disease. Croatian version is yet not available. With a permission of AbbVie company investigators want to make a Croatian version of the Ocular Surface Disease Index Questionnaire (Cro-OSDI).
详细描述
Aim is to translate, adapt and validate the Croatian version of the Ocular Surface Disease Index (OSDI) Questionnaire. Validation process of the Croatian version of the OSDI questionnaire will be accomplished in two phases: the translation and assessment of psychometric properties.
The translation process will involve the following steps based on the previously established guidelines. First is forward translation, the second is backward translation and the third is pilot study. The final version (the Cro-OSDI) will be used to test psychometric properties of the Croatian version of the questionnaire.
Eligible participants will complete the Cro-OSDI and and the previously validated Croatian version of the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25). After completing the respective questionnaires, the participants will undergo a complete ophthalmic examination for both eyes and dry eye tests (corneal fluorescein staining, lissamine green staining, Schirmer test type I and II, tear break-up time (TBUT), noninvasive tear breakup time (NIBUT)).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •native Croatian-speaking participants with normal cognitive ability
- •DED diagnosis complied with those defined by the DEWS II
- •DED for at least 3 months
- •BCVA logMAR< 0.6 or better
排除标准
- •symptoms of conjunctivitis
- •a history of contact lens use
- •previous intraocular or ocular surface surgeries within the previous 6 months
- •allergies
- •eyelid malpositions
- •Parkinson disease
- •hereditary corneal disease
- •any other disease that could affect blinking
结局指标
主要结局
OSDI translation to the Croatian language and Cro-OSDI score measurement
时间窗: 2 weeks
Ocular Surface Disease Index will be first translated into Croatian language in forward and backward manner. Further on, translated (Cro-OSDI) will be conducted on population of selected participants, and the Cro-OSDI score will be determined. OSDI score is in a range from normal (0-12 points) till severe dry eye (33-100 points).
次要结局
- Cro-OSDI score comparison with the NEI VFQ-25 score(2 months)
- Cro-OSDI score comparison with the Oxford scale, SICCA scale, scaled filter paper strips.(2 months)
研究者
Karla Randelovic
Study Coordinator, Ophthalmology Consultant
University Hospital "Sestre Milosrdnice"