CLinical Evaluation of the FluidVision AIOL for Accommodation Restoration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PowerVision
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of an investigational IOL in providing a range of vision as compared to a commercially available trifocal IOL in subjects undergoing cataract extraction and IOL implantation.
详细描述
Upon obtaining written informed consent and confirmation of subject eligibility via preoperative assessments, subjects were randomized in a 1:1 ratio to receive either the investigational IOL or the commercially available trifocal IOL in both eyes. The second eye for each subject was implanted after completion of the 1-week follow up for the first implanted eye. The expected total duration of participation for each subject was up to 14 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Require cataract extraction by phacoemulsification;
- •Corrected Distance Visual Acuity (CDVA) worse than 20/40 Snellen, or presence of visually significant lens opacity;
- •Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter.
排除标准
- •Use of current medications that may affect accommodation or confound study results;
- •Systemic disease that may increase the operative risk or confound results;
- •Ocular conditions or degenerative disorders that may predispose the subject to future complications;
- •Monocular subjects or significant permanent visual function loss in 1 eye;
- •Previous ocular surgery in either eye that may confound the results or increase the risk to the subject.
结局指标
主要结局
Distance Corrected Near Visual Acuity (DCNVA) at 100% Contrast - First Implanted Eye
时间窗: Month 6 postoperative
Visual acuity was tested at a distance of 40 centimeters with distance correction (plus or minus power) in place.
次要结局
- Distance Corrected Near Visual Acuity (DCNVA) at low contrast - First Implanted Eye(Month 6 postoperative)
- Distance Corrected Intermediate Visual Acuity (DCIVA) at 100% Contrast - First Implanted Eye(Month 6 postoperative)
- Percentage of Eyes with 20/32 or Better Visual Acuity Between 4 meters and 40 centimeters on the Defocus Curve(Month 6 postoperative)