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
- 1
- 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.
研究组 & 干预措施
FluidVision
FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.
干预措施: FluidVision AIOL (Device)
FluidVision
FluidVision AIOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.
干预措施: Cataract surgery (Procedure)
PanOptix
Commercially available trifocal IOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.
干预措施: Cataract surgery (Procedure)
PanOptix
Commercially available trifocal IOL implanted in the capsular bag of the eye during cataract surgery. Both eyes were implanted, with the second eye surgery occurring after the Week 1 follow up for the first eye surgery.
干预措施: AcrySof IQ PanOptix Trifocal IOL (Device)
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)