To investigate the role of Autologous Platelet rich Plasma eyedrops in the management of symptomatic Dry Eye Disease
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Saba Firdos Khan
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Improvement in visual acuity, Schirmer score, OSDI, Tear break up time and Corneal staining
概览
简要总结
This prospective interventional study evaluates the efficacy and safety of autologous platelet-rich plasma (PRP) eye drops in patients with moderate to severe symptomatic dry eye disease unresponsive to conventional therapy. PRP, rich in growth factors and anti-inflammatory mediators, is prepared from the patient’s own blood and applied topically for 12 weeks. Outcome measures include improvement in visual acuity, OSDI score, Schirmer’s test, TBUT, and corneal staining at baseline and follow-up visits. The study aims to assess PRP as a potential biological therapy for ocular surface healing in dry eye disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All patients with symptomatic dry eye with an OSDI score of >40, 2.A TBUT score of <10s , 3.Positive CFS score 4.Schirmer test score <10mm in 5 mins, 5.Able to give informed consent were included in the study.
排除标准
- •1.Patients who were unwilling or unable to give consent, 2.Refused follow up plans, 3.Uncooperative patients, 4.Under 18 years of age and over 75 years, 5.Contact lens user, 6.Patients with active ocular infection, 7.Patients with history of refractive surgeries.
结局指标
主要结局
Improvement in visual acuity, Schirmer score, OSDI, Tear break up time and Corneal staining
时间窗: baseline, 1 month, 2 months, 3 months
次要结局
未报告次要终点
研究者
Saba Firdos Khan
NSCB Medical college and hospital, jabalpur