Comparison of Air and Expansile Gas in Pneumatic Retinopexy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- The retinal reattachment rate (calculated from the number of patients who had post-operative attached retinas divided by the total number of patients treated)
研究概览
简要总结
The objective of the study is to evaluate the results of using air versus expansile gas (perfluoropropane) in the treatment of rhegmatogenous retinal detachment by pneumatic retinopexy, comparing the retinal reattachment rate and post-operative visual recovery.
详细描述
To the best of the investigators' knowledge there have been no clinical trials to compare air and expansile gas in pneumatic retinopexy. The investigators hypothesize that both air and expansile gas have the same properties of gas and remain in the eye for 5-6 days which is long enough to have moderate chorioretinal adhesion to seal the retinal break. If the investigators can prove that air is equivalent to expansile gas in this procedure, it can save a lot of money for the country. Therefore, the investigators are conducting a randomised controlled double-blind study to compare the results of using air and perfluoropropane in pneumatic retinopexy for treatment of rhegmatogenous retinal detachment.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Superior retinal break from 8 o'clock to 4 o'clock
- •Single retinal break not greater than 2.5 clock hours in size
- •Multiple breaks not greater than 3 clock hours away
- •No (or minimal) proliferative vitreoretinopathy
- •Physically and mentally co-operated in post-operative head positioning
- •Signed informed consent form for the study
排除标准
- •Ocular media opacities
- •Advanced glaucoma
- •Aphakia or pseudophakia
- •Previous ocular surgeries
- •One-eyed patients
- •Subject did not sign informed consent form
结局指标
主要结局
The retinal reattachment rate (calculated from the number of patients who had post-operative attached retinas divided by the total number of patients treated)
时间窗: 1 week
次要结局
- The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)(6 weeks)
研究者
Yosanan Yospaiboon
Professor
Khon Kaen University