Assessing the Impact of eSight Go At-Home Usage in Individuals With Visual Impairment

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство At Home Use
  Participants will take the device home for 4 weeks to use in daily living, such as the home and community settings. There will be regular follow-up phone calls once per week from a member of the research team (e.g., an occupational therapist, or low vision therapist) who is familiar with the device to assist with possible troubleshooting as well as device use strategies. The follow up calls will also collect information about device use time and activities. The device will be returned at visit 2

Первичные конечные точки

• Change in Visual Acuity [Срок оценки: Pre-intervention and post-intervention at 4 weeks]
• Change in Reading Performance [Срок оценки: Pre-intervention and post-intervention at 4 weeks]

Вторичные конечные точки (1)

• Change in Mobility [Срок оценки: Pre-intervention and post-intervention at 4 weeks]

Критерии участия

Критерии включения

• Aged 18 to 90.
• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brooks Rehabilitation — Jacksonville

Идентификаторы

NCT: NCT07149259 · PRO00085670

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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