Comparative Study 23G Versus 27G Vitrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in post-operative outcome of redness
研究概览
简要总结
Investigator-initiated, comparative double-arm, mono-center, prospective, interventional case study to determine whether ultra-small gauge surgery (27G gauge needle) improves postoperative outcome and patient morbidity.
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 (Participant)
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 aged over 18
- •No prior vitrectomy surgery in the study eye
- •No prior inclusion in this trial
- •Scheduled for vitrectomy for floater removal or macular surgery
排除标准
- •Patients with serious heart, lung, liver, or kidney dysfunction
- •Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis and other eye disease that impacts the outcome of vitrectomy surgery Patients with HIV (Human Immune-deficiency Virus)
- •Patients with history of drug abuse or alcoholism
- •Patients participating in other drug or medical device clinical trials before screening for this trial
- •Pregnancy, preparation for pregnancy during clinical trial, or breastfeeding
- •Belief by the investigator that a patient's condition would hinder the clinical trial, such as a patient prone to mental stress, loss of control of mood, or depression
结局指标
主要结局
Changes in post-operative outcome of redness
时间窗: 1 week
Scoring the amount of redness on a scale 0-4 through eye photos
Changes in post-operative outcome of pain
时间窗: 1 week
By assessing the amount of pain on a visual analogue scale (score 0 - 9)
Changes in post-operative outcome of measured inflammation
时间窗: 1 week
Measuring the amount of inflammation by measurement of Flare (photon/ms)
Changes in post-operative outcome in grading of anterior chamber cells
时间窗: 1 week
Clinical assesment by slit lamp (Tyndall 0 - 3 and Cells 0 - 3)
次要结局
- Post-operative parameter: Visual acuity(1 week)
- Post-operative parameter: Pain assessment(1 week)
- Post-operative parameter: Intraocular pressure(1 week)
研究者
Prof. Dr. Peter Stalmans
Prof. Dr. Peter Stalmans
Universitaire Ziekenhuizen KU Leuven