Comparative Study 27G Vitrectomy vs Larger Gauge Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- changes in post-operative outcome of pain
研究概览
简要总结
Two-arm, mono-center, prospective, interventional comparative case study to compare postoperative recovery between the 27G and larger gauge surgical approach.
详细描述
A prospective randomized comparison of postoperative recovery between 27-gauge and larger gauge surgical approaches to evaluate efficiencies and postoperative outcomes of the surgical gauges. Fifty patients who were scheduled to undergo pars plana vitrectomy (PPV) for floaters or macular surgery were treated with either 27-gauge or 23-gauge techniques and assessed for efficiency of the procedures as well as a variety of postop indicators of pain and inflammation.
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 (for the same eye)
- •No prior inclusion in this trial
- •Scheduled for vitrectomy for floater removal or macular surgery (including macular holes) without endotamponades such as PFCL, Gas, Silicone oil). (Air tamponade is allowed )
排除标准
- •• Patients with serious heart, lung, liver, or kidney dysfunction
- •Patients with proliferative diabetic retinopathy, endophthalmitis, uveitis, eyes with refraction >+5D or exceeding -8D , or other eye disease that impacts the outcome of vitrectomy surgery
- •Patients with HIV
- •Patients with history of drug abuse or alcoholism
- •Patients participating in other drug or medical device clinical trials before screening for this trial
研究组 & 干预措施
27 gauge needle vitrectomy surgery
ultra-small gauge
干预措施: vitrectomy (27G gauge or larger needle) (Device)
larger than 27 gauge (23G or 25G) needle vitrectomy surgery
23-gauge and 25-gauge instruments are a little larger in size
干预措施: vitrectomy (27G gauge or larger needle) (Device)
结局指标
主要结局
changes in post-operative outcome of pain
时间窗: day 1 postoperative
by assessing the amount of pain on a visual analogue scale (score 0-9)
changes in post-operative outcome of redness
时间窗: day 1 postoperative
scoring the amount of redness on a scale 0-4 through eye photos
changes in post-operative outcome in grading of anterior chamber cells
时间窗: day 1 postoperative
clinical assessment by slit lamp examination (Tyndall 0-3 and Cells 0-3)
次要结局
- visual acuity(day 1 postoperative)
- pain-assessment(1 week postoperative)
- intra-ocular pressure(day 1 postoperative)