The Surgical Outcomes of Long-shaft Vitrectomy Probe for Vitreoretinal Diseases in Highly Myopic Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- operation time
研究概览
简要总结
This study aimed to compare the safety and efficacy of vitrectomy probe with different shaft lengths in vitreoretinal surgery of highly myopic patients. In this randomized controlled study, highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery will be enrolled. The enrolled patients will be randomized into "30 mm shaft length group"(trial group) and "27mm shaft length group"(controlled group). We will compare the rate of wound leakage, hypotony, subconjunctival hemorrhage, probe bending, trocar removal, and endophthalmitis between the two groups. We would like to evaluate the efficacy and safety of the 30 mm shaft length vitrectomy probe.
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
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Highly myopic patients (axial length > 26mm) with vitreoretinal diseases or maculopathy requiring pars plana vitrectomy
排除标准
- •Previous history of pars plana vitrectomy
- •Surgical plan combining encircling buckle
- •Silicone oil or perfluorocarbon liquid use intraoperatively
- •Previous history of pterygium surgery, trabeculectomy, glaucoma surgery
- •Previous history of corneal, conjunctival, or scleral laceration
- •History of connective tissue disease
结局指标
主要结局
operation time
时间窗: intra-operative
record the operation time and time of core vitrectomy
trocar removal rate
时间窗: intra-operative
trocar removal would be performed if the length of vitrectomy probe was not adequate
次要结局
- instrument bending(intraoperative)
