Autologous Serum Eye Drops in Dry Eye Syndrome: Clinical Efficacy and Safety Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Visual acuity
研究概览
简要总结
This study aims to evaluate the clinical efficacy and safety of autologous serum eye drops (ASEDs) in patients with moderate-to-severe dry eye syndrome who are refractory to conventional artificial tear therapy.
详细描述
Dry Eye Syndrome (DES) is a highly prevalent ocular condition that significantly affects quality of life, with global prevalence estimated at 5%-50%, depending on population and diagnostic criteria.
Autologous Serum Eye Drops (ASEDs) have emerged as a promising therapy due to their composition, which is rich in vitamin A, epidermal growth factor, fibronectin, and transforming growth factor-β. These components mimic natural tears and promote epithelial healing, reduce inflammation, and enhance tear film stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged less than 18 years.
- •Both sexes.
- •Diagnosed with moderate to severe dry eye syndrome (DES) refractory to artificial tears.
排除标准
- •Active ocular infection.
- •Recent ocular surgery.
- •Systemic immunosuppressive therapy.
- •History of allergy to blood-derived products.
结局指标
主要结局
Visual acuity
时间窗: 12 weeks post-procedure
Visual acuity will be measured.
次要结局
- Improvement in Ocular Surface Disease Index (OSDI)(12 weeks post-procedure)
- Incidence of adverse events(12 weeks post-procedure)
研究者
Hossam Abdelfattah Husein Hassan
Fellow of Ophthalmology, Sohag Teaching Hospital, Egypt.
The General Authority for Teaching Hospitals and Institutes