Transpalpebral Micro-Current Electrical Stimulation for the Treatment of Dry Age-Related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Measure the increase in ETDRS visual acuity for those treated with Nova Oculus™ device to control subjects who did not receive active treatment.
研究概览
简要总结
Assess the effectiveness of externally applied micro current electrical stimulation on improving the ETDRS visual acuity in subjects with vision loss from dry age-related macular degeneration (AMD)
详细描述
Micro-current electrical stimulation will be used to treat /each eye in a group of subjects with dry AMD. 60 subjects will be randomly divided into two groups. A ratio of 1:3 will be maintained between control and the experimental groups. In the treatment group, subjects will undergo a treatment session to the enrolled eyes daily for three days during week 1, followed by a single treatment session during weeks 2, 14 and 26 with the Nova Oculus device. A second group of subjects will act as the control group. This group will undergo sham treatment at the same treatment intervals with a non-functional Nova Oculus device. ETDRS visual acuity will be performed on all subjects at enrollment prior to each treatment and at four weeks from enrollment. The effect of treatments with the Nova Oculus device compared to sham treatment on the ETDRS visual acuity of subjects with dry AMD will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Fifty years of age or older
- •Male or female
- •Best-corrected vision 20/50 to 20/200 for each enrolled eye
- •Confirmed diagnosis of dry AMD
- •Vision loss attributable to dry AMD
- •Subjects must be highly motivated, alert, oriented, mentally competent and able to understand and comply with the requirements of the study, abide by the restrictions, return for all required visits, and provide voluntary informed consent
排除标准
- •Any visually significant retinal pathology other than dry AMD
- •Previous intravitreal injection
- •Seizure disorders
- •Previous vitreo-retinal surgery. (ERM, PPV, RD etc)
- •Dense cataract
- •Eyelid pathology at the treatment sites
- •Glaucoma patients with a visual field mean defect of greater than 10dB on Humphrey visual field testing
- •Glasses are up to date (prescription <1 year old)
- •Any prior electrical micro-stimulation treatment to the eyes
- •Poor general health
- •Active cancer
- •Life expectancy less than 12 months
- •Non-ambulatory
- •Not considered suitable for participation for any other reason
结局指标
主要结局
Measure the increase in ETDRS visual acuity for those treated with Nova Oculus™ device to control subjects who did not receive active treatment.
时间窗: 26 weeks
次要结局
未报告次要终点