NCT04062084Unknown不适用
Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Surgical success rate
研究概览
简要总结
To compare the safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of lens subluxation.
- •Patients need to undergo lens subluxation surgery
排除标准
- •Active intraocular inflammation
- •The intraocular pressure (IOP) was higher than 25 mmHg
- •The endothelial cell count (ECC) was less than 1,200 cells/mm2
- •Combined with other eye diseases
- •Combined with other serious systemic diseases
结局指标
主要结局
Surgical success rate
时间窗: through study completion, an average of 1 year
Surgical success rate of operation with different retractor
次要结局
- intraocular pressure(1 day, 1 week, 1 month, and 3 month postoperation)
- Successful implantation rate of intraocular lens(through study completion, an average of 1 year)
- Visual function(1day postoperation，1 week，1 month， 3month postoperation)
- endothelial cell count(1 week, 1 month, and 3 month postoperation)
研究者
研究点 (1)
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