NCT03895034已完成不适用
A Single Center Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
研究概览
简要总结
The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 unilateral or bilateral implantation of the RxLAL.
- •Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
- •Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
- •Willing and able to comply with the requirements for study specific procedures and visits.
排除标准
- •Study eye with pseudoexfoliation.
- •Study eye with diabetes with any evidence of retinopathy.
- •Study eye with evidence of glaucomatous optic neuropathy.
- •Study eye with history of uveitis.
- •Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless 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.
- •Study eye with history of ocular herpes simplex virus.
- •Study eye with history of a congenital color vision defect
结局指标
主要结局
Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
时间窗: 3 months post op
次要结局
未报告次要终点
研究者
研究点 (1)
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