CTRI/2023/08/056275尚未招募2 期
Evaluating The Efficacy of Subthreshold Micropulse focal Laser in Non Centre involving Clinicallysignificant Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1.Change in Macular Volume
研究概览
简要总结
This is a Prosective Randomised Control trial to evaluate the efficacy of Subthreshold Micropulsefocal yellow (577nm) laser on non centre involving CSME by comparison of change in macularthickness and volume. It also compares its effect as compared to the Conventional laser . We willcarry out investigations like OCT, OCT-A ,FFA,FAF, Pseudocolor fundusphoto ,Before interventionand at 1 month , 3 month and 6 month and compare the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with non centre involving Clinically significant Diabetic macular Edema 2.Central Macular Thickness on OCT<350microns 3.Patient willing to give Informed Consent 4.Patient willing to come for follow ups.
排除标准
- •1.Central Macular thickness >350microns 2.Retinal disorder other than Diabetic Retinopathy 3.Associated Glaucoma 4.Unwilling to give consent.
结局指标
主要结局
1.Change in Macular Volume
时间窗: 1month, 3month & 6month
2.Change in Macular thickness of 3mm & 6mm zones of ETDRS grid
时间窗: 1month, 3month & 6month
次要结局
- 1.Change in density of Hard exudates assessed(using Image J.)
研究者
研究点 (1)
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