VisiOn Restoration With the FluidVisION AIOL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PowerVision
- 入组人数
- 85
- 主要终点
- Distance Corrected Visual Acuity
研究概览
简要总结
The objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients undergoing cataract extraction and IOL implantation.
详细描述
This study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational IOL in subjects undergoing cataract extraction and IOL implantation. The study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational IOL to a commercially available monofocal IOL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- Single (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
- •Corrected distance visual acuity (CDVA) worse than 20/40, or presence of visually significant lens opacity;
- •Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter (D);
- •Calculated IOL power within range.
排除标准
- •Current medication that may affect accommodation;
- •Systemic disease or concomitant medication that may increase operative risk or confound results;
- •Ocular conditions that may predispose the subject for future complications;
- •Monocular subjects or subjects with significant permanent visual function loss in fellow eye;
- •Previous intraocular or corneal surgery in either eye that may confound the results or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye;
- •Grade 4 cataract of any type.
结局指标
主要结局
Distance Corrected Visual Acuity
时间窗: Month 6 postoperative
Visual acuity was measured with distance correction (plus or minus power) in place.
International Organization for Standardization (ISO)-defined Cumulative and Persistent Adverse Events for Posterior Chamber IOL
时间窗: Up to Month 6 postoperative
Adverse events were categorized per ISO 11979-7: Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations.
Accommodative Amplitude (AA)
时间窗: Month 6 postoperative
Accommodative amplitude is the ability of the eye to change its focus from distant to near objects.
次要结局
- Uncorrected Visual Acuity(Up to Month 6 postoperative)
- Minimum Add Power Required to Achieve Best Corrected Near Visual Acuity(Up to Month 6 postoperative)
- Accommodative Amplitude(Month 3 postoperative)