NCT02843594Unknown4 期
A Study to Assess the Clinical Outcomes of Surgical Phaco Segmentation Techniques in Patients Undergoing Cataract Surgery
Iantech, Inc1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2016年8月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Cumulative Dispersed Phaco energy
研究概览
简要总结
The purpose of this research study is to evaluate the clinical outcomes of different cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits as confirmed by provision of written informed consent.
- •Subjects with a visually significant cataract scheduled to undergo cataract surgery
- •Subjects > 18 years of age
- •BCVA at baseline not better than 20/40
- •Grade 1+ cataracts
排除标准
- •Subjects not able to complete the informed consent form
- •Subjects < 18 years of age
- •Polar cataracts
- •Zonular instability
结局指标
主要结局
Cumulative Dispersed Phaco energy
时间窗: Intraoperative
Total phaco power and energy used as recorded by the phaco machine
次要结局
- Endothelial cell loss(1 month)
研究者
研究点 (1)
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