NCT06198452尚未招募不适用
Vision Improvement for Patients With Age-Related Macular Degeneration
VIS, Inc.0 个研究点目标入组 200 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Visual Acuity
研究概览
简要总结
This study is being conducted to assess the safety and efficacy of the VIS, LLC (VIS) Opti-K Low Vision Aid Device and treatment to provide vision improvement to patients with age-related macular degeneration.
详细描述
This study is being conducted to assess the safety and efficacy of the VIS, LLC (VIS) Opti-K Low Vision Aid Device and treatment to provide vision improvement to patients with age-related macular degeneration.
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
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who meet all of the following criteria are candidates for this study:
- •Male or Female
- •Patient is at least 50 years old.
- •Patient has diagnosed end stage dry or wet age-related macular degeneration in one or both eyes, as verified by a complete ocular examination.
- •Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
- •Patient has manifest refraction, spherical equivalent (MRSE) between -1.50 D to 1.50 D in eye(s) to be treated.
- •Patient has moderate to severe vision impairment due to age-related macular degeneration with best spectacle-corrected distance visual acuity (CDVA) of 20/80 or worse (decimal less than or equal to 0.25; logMAR ≥ 0.60).in the better eye.
- •Patient has CDVA of 20/400 or better (decimal greater than or equal to 0.05; logMAR ≤ 1.30) in the worse eye.
- •Patient is not a contact lens (CL) wearer.
- •Patient is willing and able to comply with all examinations.
- •Patient must be competent to sign an informed consent form before study entry.
排除标准
- •Subjects who meet any of the following criteria are to be excluded from this study:
- •Corneal disease or corneal disorder in either eye.
- •Pathological retinal morphology in either eye that completely affects the entire 10° (3 mm diameter) of the retina centered on the foveola.
- •Gonzalez-Markowitz chart Potential Visual Acuity (PVA) in the eye to be treated that is not improved by at least four lines compared to CDVA;
- •Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma;
- •Previous corneal surgery in the eye to be treated; and
- •Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.
结局指标
主要结局
Visual Acuity
时间窗: 1 year
Standard measurements of visual acuity before and after treatment
次要结局
未报告次要终点
研究者
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