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临床试验/NCT04637685
NCT04637685Unknown不适用

The Enhanse Study The Effect of Infusion Pressure on the Outcomes of Phacoemulsification Surgery

South Tyneside and Sunderland NHS Foundation Trust0 个研究点目标入组 70 人开始时间: 2021年3月1日最近更新:
适应症

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

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)

研究者

发起方
South Tyneside and Sunderland NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

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