Clinical Investigation of Corneal Incision Size After IOL Implantation With Preloaded Delivery Devices and a Manual Delivery Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 主要终点
- Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)
研究概览
简要总结
The purpose of this study is to compare corneal incision size after IOL implantation with the use of one of four IOL delivery systems (three preloaded IOL delivery systems and one manually loaded IOL delivery system).
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comprehend and sign a statement of informed consent;
- •Willing and able to complete all required postoperative visits;
- •Cataract;
- •Planned cataract removal by phacoemulsification;
- •Calculated lens power from 18.0 through 27.0 D inclusive;
- •Preoperative astigmatism <1.0D;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Systemic disease that affects the cornea;
- •Any inflammation or edema of the cornea;
- •Previous or planned refractive or corneal surgery during the subject's participation in the study;
- •Previous corneal transplant;
- •Previous retinal detachment;
- •Pregnancy or lactation, current or planned, during the course of the study;
- •Current participation in another investigational drug or device study that may confound the results of this investigation;
- •Any condition observed before or during surgery that in the surgeon's medical opinion may affect the success of the cataract surgery;
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)
时间窗: Day 0, operative day
Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.
次要结局
- Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)(Day 0, operative day)