Comparison of fluorescein tear film breakup time with non invasive tear fim breakup time using Lacridiag in patients with dry eye
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To assess the correlation between Non-Invasive Tear Film Break-Up Time (NITBUT) measured by LacriDiag® and the Fluorescein Tear Film Break-Up Time (FTBUT) in patients diagnosed with dry eye disease.
研究概览
简要总结
Dry Eye Disease (DED) is a common ocular condition characterized by tear film instability, causing discomfort and visual disturbance.
The conventional method, Fluorescein TBUT (FTBUT), though widely used, is invasive and can induce reflex tearing, affecting accuracy.
To address these limitations, Noninvasive TBUT using devices like Lacridiag has been developed.
Principle: A Placido disc projects concentric rings on the cornea.
The stability of the tear film assessed by monitoring distortion or break-up of these rings over time.
Longer NITBUT suggests stable tear film, while a short NITBUT suggests instability.
In this study we are comparing invasive TBUT vs Noninvasive TBUT.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 18 years and above of both sexes 2.Patients with symptoms suggestive of dry eye (burning, grittiness, foreign body sensation, photophobia etc).
- •3.Positive Ocular Surface Disease Index (OSDI) score more than
- •4.Willingness to give informed consent and undergo tests.
排除标准
- •1.History of ocular surgery or trauma in the past 6 months.
- •2.Presence of active ocular infection, inflammation or allergy.
- •3.Patients unable to cooperate with diagnostic procedures.
结局指标
主要结局
To assess the correlation between Non-Invasive Tear Film Break-Up Time (NITBUT) measured by LacriDiag® and the Fluorescein Tear Film Break-Up Time (FTBUT) in patients diagnosed with dry eye disease.
时间窗: BOTH TESTS ARE ASSESSED IN SAME DAY ONE AFTER OTHER
次要结局
- To evaluate the diagnostic accuracy of NITBUT, using FTBUT as the clinical reference standard.
研究者
NIRANJANA P
Sankara Eye Hospital, Coimbatore