NCT03771352已完成不适用
A Prospective Multi-Center Clinical 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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 3
- 主要终点
- Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
研究概览
简要总结
For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and quality of vision will be assessed 6 months postoperatively.
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 —（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 the RxLAL.
- •Greater than the age of 40 on the day the cataract surgery is performed.
- •Preoperative keratometric cylinder of >=0.50 D and <=4.00 D in both eyes.
- •Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without glare source in both eyes.
- •Willing and able to comply with the requirements for study specific procedures and visits.
排除标准
- •Zonular laxity or dehiscence.
- •Age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
- •Retinal degenerative disorder or macular disorder (other than mild macular degeneration) that is expected to cause future vision loss.
- •History of uveitis
- •Keratoconus or suspected of having keratoconus.
- •Previous corneal or intraocular surgery, except eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
- •Serious co-morbid conditions that in the judgement of the investigator makes inclusion in the study not in the best interest of the subject.
- •Subjects taking systemic medications 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
- •History of congenital color vision defect
结局指标
主要结局
Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
时间窗: at 6 months postop
Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better
次要结局
未报告次要终点
研究者
研究点 (3)
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