20- Versus 23- Gauge System for Pars Plana Vitrectomy: A Prospective Randomized Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Conjunctival Injection
研究概览
简要总结
The aim of the present study is to compare the functional and clinical differences and advantages between a standard operating system and a newly developed even smaller system for pars plana vitrectomy.
The present study may work out the possible advantages and disadvantages between the routinely used 20-gauge vitrectomy system and the newly developed 23-gauge device.
详细描述
60 patient randomized into 2 groups of 30 each. All of them operated in general anesthesia, vitrectomized and cataract extracted by phacoemulsification if indicated. Preoperative and postoper5ative controls at days 1,2,3 and week 1, month 1,3 and 12 performed. Parameters of interest are: postoperative conjunctival injection, pain, eye pressure, complications intra- and postoperative as well as the durations of surgery divided into opening time, vitrectomy time, retinal manipulation time, closing time.
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
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
- •Over 18 years of age
- •Written form of consent
- •Vitreous and retinal pathologies requiring surgery
排除标准
- •Previous history of vitreous or retinal surgery
- •Pregnant or breastfeeding women
- •Prohibiting general medical conditions or diseases
- •No informed consent signed
- •Under 18 years of age
结局指标
主要结局
Conjunctival Injection
Subjective postoperative recovery
次要结局
- Surgery time
- Intraocular pressure
- Visual acuity
- Technically successful surgery (from surgeon's view)
- Intra- and postoperative complications