Tilt and Tumble vs Divide and Conquer - a Unique Comparison of the Two Cataract Surgery Methods
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Differences in time used during phacoemulsification during surgery between the methods investigated
研究概览
简要总结
The purpose of this study is to compare two different methods used during cataract surgery to remove the lens in the eye.
详细描述
After being informed about the study and potential risks, all participants who have signed the written informed consent will be randomized to undergo cataract surgery with either the method called "Divide and Conquer" or "Tilt and Tumble". Pre- per- and postoperative measurements from the surgery will be filed and compared later on by the investigator.
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 (Investigator)
入排标准
- 年龄范围
- 56 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Very narrow anterior chamber
- •Born after 1965
结局指标
主要结局
Differences in time used during phacoemulsification during surgery between the methods investigated
时间窗: Immediately after the intervention/procedure/surgery
Time, measured in seconds (s), will be measured from the start til the end of phacoemulsification
Measurement of clinical och subclinical macular oedema before and after surgery. Change is being assessed.
时间窗: Pre-intervention surgery and 14 days after surgery.
Clinical or subclinical macular oedema is a known complication to cataract surgery. Macula will be measured with an Ocular Coherence Tomography (OCT) before and after surgery. Retinal thickness in macula will be measured in micrometer. Data is collected after each surgery from the phaco apparatus throughout the study.
Difference in corneal endothelial cell density after cataract surgery between the study groups investigated. Before and after surgery. Change is being assessed.
时间窗: Pre-intervention surgery and 14 days after surgery.
During cataract surgery the participants loose some of the endothelial cells. The investigator can measure endothelial cell density (CD) with an endothelial cell camera. This will be done before and after surgery in both study groups.
Differences in energy during phacoemulsification between the methods investigated.
时间窗: Immediately after the surgery
Energy used during phacoemulsification is measured during each surgery. It is measured with the unit Cumulative Dissipated Energy (CDE).
次要结局
未报告次要终点
研究者
Johan Ursberg
Chief Medical Officer
Aleris Eye