CTRI/2025/10/095572招募中不适用
Evaluating Evidence-Based Strategies for the Diagnosis, Subclassification, and Management of Patients with Dry Eye Disease: A Longitudinal Cohort Study.
未提供1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年11月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The primary outcome of the study will be the change in the OSDI-6 score from baseline to 3 months and 6
研究概览
简要总结
Dry Eye Disease (DED) is a highly prevalent ocular morbidity with multifactorial etiology. Despite
available guidelines, diagnosis and management remain inconsistent across clinical settings in India, leading
to suboptimal outcomes. A structured, driver-based approach per TFOS DEWS III is required to bridge the
gap between evidence-based consensus and real-world clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 to 80 years.
- •Presence of dry eye symptoms (OSDI 6 more than or equal to 4) and at least one clinical sign of DED (NIBUT less than10 secs, TMH less than or equals to 0.20 mm, or mucin lissamine green staining and more than 9 punctate spots).
- •Willingness to provide informed consent and comply with follow-up visits.
- •Literate patients can read and complete validated questionnaires (OSDI 6 symptom tools).
排除标准
- •History of ocular surgery (e.g., refractive or cataract surgery) within the past 12 months.
- •Active ocular infection or severe ocular surface disease at baseline.
- •Use of topical ocular medications within 24 hours before baseline evaluation.
- •Corneal scarring or irregularities interfere with tear film assessment.
- •Inability or unwillingness to adhere to the follow-up schedule.
结局指标
主要结局
The primary outcome of the study will be the change in the OSDI-6 score from baseline to 3 months and 6
时间窗: At baseline 3 months and 6 months.
months, providing insight into the improvement or persistence of patient-reported symptoms at baseline 3 months and 6 months.
时间窗: At baseline 3 months and 6 months.
次要结局
- Secondary outcomes will include changes in objective clinical parameters such as non-invasive tear break-(up time (NITBUT), tear meniscus height (TMH), & ocular surface staining patterns, which together reflect)
研究者
Rahul Roy
Nethradhama Super speciality eye hospital
研究点 (1)
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