Clinical Effects of "Gas Bubble Technique" on Corneal Endothelial Recovery After Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Endothelial cell loss (ECL)
研究概览
简要总结
To investigate the efficiency and safety of using "Gas Bubble Technique" to reduce corneal endothelial damage in hard nucleus cataract patients.
详细描述
The study is designed to: test the hypothesis that the "Gas Bubble Technique" is an effective method for reducing corneal endothelial damage. Describe and evaluate the effects of "Gas Bubble Technique" on a well-defined group of patients over a 1-month period following treatment.
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 (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
- •Sign the informed consent approved by the Ethics Committee
- •18-80 years of age
- •Catract patients with hard nucleus (LOSIII N Score ≥4) who are scheduled for phacoemulsification
- •Feasible for all visits and willing to follow instructions from the study investigator
排除标准
- •Any ocular surgery history
- •Currently diagnosis of severe ocular disease and under medication
- •Uncontrolled systemic diseases
研究组 & 干预措施
Gas bubble group
Inject the sterile air into the anterior chamber after the conventional cataract surgery to reduce the corneal endothelial damage
干预措施: Gas bubble technique (Procedure)
The control group
Conventional cataract surgery
结局指标
主要结局
Endothelial cell loss (ECL)
时间窗: 1 week and 1 month
The endothelial cell loss (ECL) was calculated as the percentage change in ECD from preoperative to postoperative values relative to the preoperative ECD.
次要结局
- Central corneal thickness (CCT) increase rates(1 week and 1 month)
- Coefficient of variation (CV)(1 week and 1 month)
- hexagonality (HEX)(1 week and 1 month)
研究者
Rui Feng, PhD
Principal Investigator
Sichuan Provincial People's Hospital