NCT05202808已完成不适用
RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 27
- 主要终点
- Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
研究概览
简要总结
The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL.
- •Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
- •Willing and able to comply with the requirements for study specific procedures and visits.
- •Able to complete a written questionnaire in English.
排除标准
- •Pre-existing macular disease in either eye.
- •Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
- •History of uveitis in either eye.
- •Evidence of ectasia in either eye.
- •Previous intraocular surgery in either eye. Eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
- •Subjects taking systemic medication that may increase sensitivity to UV light.
- •Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
- •History of ocular herpes simplex virus in either eye.
结局指标
主要结局
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
时间窗: Postop Month 6
Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
时间窗: Postop Month 6
次要结局
- Rate of Endothelial Cell Density Loss(Postop Month 6)
- Rate of Retinal Findings(Postop Month 6)
研究者
研究点 (27)
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