A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 12
- 主要终点
- One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%
研究概览
简要总结
The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Select post operative assessments will be performed on both the experimental and control eye by an examiner who will be masked to the eye assignments.
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 bilateral implantation of an intraocular lens (IOL).
- •Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
- •History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-LASIK, or Epi-LASEK more than 1 year prior in both eyes.
- •Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/40 or worse with or without a glare source in both eyes.
- •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
- •Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange (RLE), or Corneal Inlay in either eye.
- •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
One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%
时间窗: Postop Month 6
Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
时间窗: Postop Month 6
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
时间窗: Postop Month 6
次要结局
- Uncorrected Distance Visual Acuity (UCDVA)(Postop Month 6)
- Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination(Postop Month 6)