The Enhanse Study The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 主要终点
- Recruitment rate
研究概览
简要总结
The effect of infusion pressure on the outcomes of phacoemulsification surgery.
详细描述
The Centurion phacoemulsification system with active sentry allows efficient cataract surgery with safe use of high vacuums, whilst allowing low and physiological infusion pressures, significantly lower than other surgical systems. There are reasons to expect that this will lead to patient benefit but it is uncertain if low infusion pressure during phacoemulsification will lead to improved outcomes. This is of particular interest in patients with vascular retinopathies such as diabetic retinopathy where the retinal vasculature is compromised, as well as glaucoma and other optic neuropathies where there is established nerve fibre layer loss.
The investigator will carry out a feasibility study with a two surgeon RCT of 70 patients with diabetic retinopathy and/or glaucoma undergoing phacoemulsification with randomisation of two different infusion pressures (low (30mmHg) versus the higher pressure (~70mmHg) as currently used) using the active sentry system with assessment of a range of exploratory endpoints.
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
- Single (Outcomes Assessor)
盲法说明
All outcome assessors will be masked to treatment group allocation. The surgeon will not be masked.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with cataract undergoing routine phacoemulsification with either diabetic retinopathy or glaucoma of any degree
排除标准
- •Dense cataract precluding adequate retinal imaging
- •posterior polar cataract
- •subluxated cataract,
- •other vision affecting pathology,
- •severe glaucoma
结局指标
主要结局
Recruitment rate
时间窗: From the start to the end of the 10 month planned recruitment period
The study has been designed as a feasibility study to assess recruitment rate. We will measure rate of recruitment to study (persons per month)
次要结局
- Retinal thickness on SD OCT(Between baseline and day 40)
- Foveal avascular zone size on optical coherence tomography angiography between baseline and day 40(Between baseline and day 40)
