Comparative Study of Indigenous Green Laser With Already Available Green Laser in Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Aurolab
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Pigmentation of burn
研究概览
简要总结
To Demonstrate that indigenous green laser produces similar treatment effect on the retina when compared with already available green laser.
详细描述
Proliferative Diabetic Retinopathy is ocular pathology in poor glycaemic controlled Diabetic patient Characterized by micro-vascular pathology with capillary closure in the retina leading to hypoxia of tissue there by formation of immature vessels to provide better oxygenation of retinal tissue.
In this randomized double blinded study a convenient sample size of 24 eyes assigned to compare indigenously developed green laser with already available green laser.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients more than 18 years of age
- •Eyes with proliferative diabetic retinopathy requiring laser photocoagulation
排除标准
- •Eyes with media opacities not allowing proper fundus photography or adequate laser photocoagulation
- •Patients requiring more than two sessions of laser photocoagulation
- •Patients who had undergone previous laser photocoagulation
- •Patients who had undergone any previous vitreo-retinal surgery
结局指标
主要结局
Pigmentation of burn
时间窗: 2 months, 4 months, 6 months post laser
Lateral spread of burn
时间窗: 2 months, 4 months, 6 months post laser
Regression of new vessels
时间窗: 2 months, 4 months, 6 months post laser
次要结局
- Retinal detachment(2 months, 4 months, 6 months post laser)
- Tractional retinal detachment(2 months, 4 months, 6 months post laser)
- Bruch's membrane rupture(2 months, 4 months, 6 months post laser)
- Choroidal detachment(2 months, 4 months, 6 months post laser)