NCT01716507已完成不适用
A Prospective, Randomized Study Comparing 23-gauge and 20-gauge Pars Plana Vitrectomy for Repair of Pseudophakic Rhegmatogenous Retinal Detachments
Wills Eye2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Assess the initial retinal reattachment rates by comparing the percentages/amount.
研究概览
简要总结
This study is a comparison (23 gauge vs 20 gauge instrumentation) of surgical instrumentation for retinal detachment repair.
详细描述
The majority of studies on PPV for PRD up to this time have used 20-gauge instrumentation. Currently, both 23-gauge and 20-gauge instrumentation are commercially available for PPV. No studies have reported the efficacy of 23-gauge PPV compared to 20-gauge PPV for primary pseudophakic RRD. As a result, many retinal surgeons choose the modality based on personal preference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Ability to provide written consent and comply with study assessments for the full duration of the study.
- •Presence of retinal detachment with history of cataract surgery.
- •Vision of hand motion or better.
排除标准
- •Presence of a very large tear or type of retinal detachment usually a result of trauma.
- •Prior eye surgery except for cataract surgery.
- •Presence of significant scar tissue.
- •Presence of retinal detachment due to hole in the macula.
结局指标
主要结局
Assess the initial retinal reattachment rates by comparing the percentages/amount.
时间窗: 1 Year
次要结局
- Change in best-corrected visual acuity by comparing letters read.(6 months)
- Reattachment rates with 23 gauge and 20 gauge PPV by comparing the amount.(1 year)
- Operating time for 23 gauge versus 20 gauge PPV (time measurement)(1 day- Day of surgery)
研究者
研究点 (2)
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