Topical Application of Latanoprost in Diabetic Retinopathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- The diameter of retinal arterioles
研究概览
简要总结
Randomized double-blinded two-year intervention study with topical application of latanoprost or placebo eye drops in patients with diabetic retinopathy.
详细描述
The primary objective is to study if a sustained contraction of pathologically dilated retinal arterioles can be obtained. Retinal arteriolar diameter and the diameter response to increased blood pressure is studied using the Dynamic Vessel Analyzer (Imedos, Germany.
The secondary objective is to study whether the intervention can halt the development of diabetic retinopathy, which is assessed by optical coherence tomography (OCT) scanning and fundus photography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 36 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-36 years old
- •Diabetes mellitus with retinopathy
排除标准
- •Pregnancy
- •Previous ocular disease other than diabetic retinopathy
- •General disease with possible influence on the eye
研究组 & 干预措施
Latanoprost
Topical treatment with latanoprost
干预措施: Latanoprost (Drug)
Placebo
Placebo arm
干预措施: Latanoprost (Drug)
结局指标
主要结局
The diameter of retinal arterioles
时间窗: 24 months
The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer
次要结局
- The severity of diabetic retinopathy(24 months)