NCT03729024已完成不适用
A Single Center Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Percent of Eyes With UCDVA of 20/20 or Better
研究概览
简要总结
The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.
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 preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D.
- •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 zonular laxity or dehiscence.
- •Study eye with pseudoexfoliation.
- •Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
- •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
研究组 & 干预措施
Light adjustable lens (LAL) and Light Delivery Device (LDD)
Experimental
干预措施: Light Adjustable lens (LAL) and Light Delivery Device (LDD) (Device)
结局指标
主要结局
Percent of Eyes With UCDVA of 20/20 or Better
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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