Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): A Multicenter, Randomized, Sham-controlled, Feasibility Device Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 20
- 主要终点
- Adverse Device Effects
研究概览
简要总结
Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).
详细描述
The i-Lumen(TM) AMD device is for in-office therapy use to deliver microcurrent electrical stimulation transpalpebrally (via the eyelid) for use by an ophthalmologist. The i-Lumen AMD device contains proprietary software with preset treatment algorithms and is calibrated at each session to the individual participant.
Up to 30 enrolled participants will be randomized (2:1 active to sham ratio) and complete the initial 5-day loading treatment sessions. Participants completing the initial loading sessions will receive two (2) days of maintenance treatments and be following and be followed through the one (1) year time point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, 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
- •Age ≥50 years.
- •Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD and/or geographic atrophy
- •Best-corrected distance visual acuity 20/40 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye
排除标准
- •History and/or evidence of exudative age-related macular degeneration in either eye
- •History and/or evidence of diabetic retinopathy in either eye
- •Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day)
- •Central chorioretinal atrophy in the study eye
- •Glaucoma in the study eye
结局指标
主要结局
Adverse Device Effects
时间窗: Through study completion, Month 12 timepoint
Incidence of device- and/or treatment-related serious adverse events (SAEs) and/or serious adverse device effects (SADE) at any point during the study
次要结局
未报告次要终点