Fasudil Eye Drop in Retinopathy Of Prematurity, Retinal Vascularization Induction and Disease Progression Inhibition, a Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Stimulation of normal retinal vascularization and disease progression inhibition
研究概览
简要总结
Eligible eyes are randomly assigned into two groups. Group A receive Fasudil eye drops (concentration 0.5 percent) twice daily. Group B, receive artificial tears drop with the same frequency. Retinal specialists who are expert in Retinopathy Of Prematurity field will perform fundus examination regularly. The examiners are blind. The progression of normal retinal vascularization and need to treatment will be documented and compared between the two study groups. The topical eye drops are used until the retinal vascularization are complete (45 week after LMP) or the patient needs to be treated.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 45 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Premature infants who are candidate for retinopathy of prematurity (ROP) screening with ROP Type 2
排除标准
- •Serious systemic problems
- •Other ocular problems Except ROP
研究组 & 干预措施
Fasudil eye drops (concentration 0.5 percent)
twice daily
干预措施: Fasudil eye drops (concentration 0.5 percent) (Drug)
receive artificial tears drop with the same frequency
干预措施: receive artificial tears drop (Drug)
结局指标
主要结局
Stimulation of normal retinal vascularization and disease progression inhibition
时间窗: 3 months
Fundoscopy and examiner judgment which will be documented by retinal camera
次要结局
- Any adverse event(3 months)
研究者
Zahra Rabbani Khah
Head of ophthalmic research center
Shahid Beheshti University of Medical Sciences