CTRI/2023/11/060210尚未招募4 期
Clinical evaluation of retinal perfusion when performing cataract surgery with low vs high preset IOP in eyes with diabetic retinopathy
Alcon Laboratories USA1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年2月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- For Posterior Pole (macula) perfusion: Retinal vessel density & Perfusion density at superficial retinal layers at the posterior pole detected by OCTA at the following time points: within 2 hours of surgery, 1 day & 1 month postoperatively
研究概览
简要总结
To study the effect of Phacoemulsification using different IOP settings, IOP 20mmHg and IOP 55 mmHg on the retinal macular circulation in patients having mild non proliferative diabetic retinopathy undergoing cataract surgery.
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
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Age-related cataract with coexisting diabetic retinopathy (mild, moderate nonproliferative diabetic retinopathy with or without diabetic retinopathy).
排除标准
- •Proliferative diabetic retinopathy with tractional disease or proliferative vitreoretinopathy Prior ocular trauma or surgery.
结局指标
主要结局
For Posterior Pole (macula) perfusion: Retinal vessel density & Perfusion density at superficial retinal layers at the posterior pole detected by OCTA at the following time points: within 2 hours of surgery, 1 day & 1 month postoperatively
时间窗: 1) 1 day postoperatively - To capture OCT angiography, anterior chamber inflammation | 2) 1 week postoperativelyTo document anterior chamber inflammation | 3) 1 month postoperativelyTo document OCT angiography
次要结局
- For Optic nerve head perfusion: Perfusion & Flux index at the RPC layer detected by OCTA at the following time points: within 2 hours of surgery, 1 day & 1 month postoperativelyCumulative Dissipated Energy(Fluid Used)
研究者
研究点 (1)
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