Diagnostic Performance of Novel OSDx Device, OSA Plus System, and Clinical Expert in the Evaluation of Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Definition: Diagnostic accuracy of OSDx compared to Clinical expert and predicate device (OSA plus)
研究概览
简要总结
This study aims to evaluate the diagnostic accuracy and reliability of a novel device called OSDx in the assessment of Dry Eye Disease. The performance of OSDx will be compared with a predicate device, OSA Plus, and with the clinical diagnosis made by an expert ophthalmologist. Parameters such as tear meniscus height, meibomian gland loss percentage, blink rate, and lipid layer thickness will be analyzed. Sensitivity, specificity, predictive values, and agreement among diagnostic methods will be assessed. Repeat testing in a subset of participants will be performed to evaluate intra and inter observer repeatability. All assessments will be conducted during a single clinic visit, with follow-up testing for reliability in a small subset within seven days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Normals and dry eye subjects (based on OSDI score).
排除标准
- •Subjects who are pregnant and nursing Subjects with recent eye surgery or trauma Individuals with uncontrolled systemic diseases such as diabetes autoimmune disorders or Sjogrens syndrome which can contribute to dry eye Subject with ocular diseases such as Glaucoma Diabetic Retinopathy Cataract ARMD Uveitis infections and inflammation Subjects undertaking medication like Antihistamines Beta-blockers Antidepressants or other Glaucoma medications for example prostaglandin analogs which may affect tear film structure or quality.
结局指标
主要结局
Definition: Diagnostic accuracy of OSDx compared to Clinical expert and predicate device (OSA plus)
时间窗: At the time of a single clinical visit (Day 0); repeat testing in 20% of participants within 1–7 days to assess test–retest reliability
Measurement: Sensitivity, specificity, positive and negative predictive values
时间窗: At the time of a single clinical visit (Day 0); repeat testing in 20% of participants within 1–7 days to assess test–retest reliability
次要结局
- Correlation of OSDx & predicate device parameters (TMH, MG loss %, blink rate analysis, & Lipid Layer Thickness).(Differences in diagnostic parameters between OSDx & predicate device (e.g., mean TM ROC, MGD, etc.).)
研究者
Dr Virender Singh Sangwan
Dr Shroffs Charity Eye Hospital