Assessing the Impact of eSight Go At-Home Usage in Individuals With Visual Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in Visual Acuity
研究概览
简要总结
This research aims to test the updated version of Gentex's device, eSight Go, an image enhancing wearable device to assist those with vision impairments limiting activities of daily living.
详细描述
Subjects will receive introductory training on the controls of the study device at the initial study visit and regular follow-up phone calls once per week from a member of the research staff (e.g., an occupational therapist, or low vision therapist) who is familiar with the study device, to assist with possible troubleshooting as well as device use strategies. You will take the study device home for four weeks to use at school, work, and various daily activities.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to
- •Best-corrected visual acuity between 20/50 to 20/400 in the better eye.
- •Subjects who have been diagnosed with an ocular condition causing visual impairment
- •Have a functional binocular field of view of at least 20 degrees.
- •Visual status stable for at least six months.
- •Demonstrate visual benefit from magnification.
- •Agree to wear the eSight Go in a variety of situations in the home and community.
- •Score ≥ 20 on the Short Orientation-Memory-Concentration Test of Cognitive Impairment (OMCT).
- •Subject must be able to provide an informed consent
- •Subject must agree to use eSight Eyewear only under conditions that will not jeopardize the safety of either the user or the device.
排除标准
- •Participant must not be currently undergoing any medical or surgical procedures resulting in unstable vision.
- •Participants who have undergone cataract, refractive, or other surgical procedures related to vision in the six-month period prior to study enrollment.
- •Severe (>20/400) visual impairment in the better seeing eye.
- •Cognitive limitations (< 20 on OMCT).
- •Participants who have undergone any vision-related injections (e.g. anti-VEGF) in the two-month period prior to the study because of active bleeding in the retina. Ongoing anti-VEGF treatments are permitted if the participant is in a "Treat and Extend" or pro re nata ("PRN") disease management, and macula is dry.
- •Participants are unable or unwilling to adhere to the examination schedules as they are described in the study protocol. This may also include participants already enrolled, who for whatever reason, have become unable or unwilling to continue the study. This may also include participants for whom the travel time to/from the study site is unacceptable.
- •Participants who self-report a history of alcoholism, drug abuse, or psychosis.
- •Participants who exhibit clinical evidence of depression, poor motivation, emotional or intellectual problems, or any other conditions which would likely limit validity of consent or appropriate responses to participate in the study or who are deemed unsuitable psychologically or physiologically for study participation by the investigator.
- •Participants who may have a conflict of interest with eSight Corp, which could reasonably influence their participation in the study.
- •Refractive error outside the range correctable by lens inserts in the device (> +/-8.00 D sph or -4.00 cyl)
结局指标
主要结局
Change in Visual Acuity
时间窗: Pre-intervention and post-intervention at 4 weeks
Early Treatment Diabetic Retinopathy Study Chart (ETDRS) assessing visual acuity. A lower logMAR value indicates an improved score.
Change in Reading Performance
时间窗: Pre-intervention and post-intervention at 4 weeks
Minnesota Low Vision Reading Test assessing reading performance. A lower logMAR value indicates an improved score.
次要结局
- Change in Mobility(Pre-intervention and post-intervention at 4 weeks)
研究者
Katelyn Jordan
Director of Vision Rehab Services
Brooks Rehabilitation