Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT02616900
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects between the ages of 13-75.
2. Subjects have been diagnosed with one of the following low vision conditions: Diabetic Retinopathy, Stargardt's Disease, Age Related Macular Degeneration, Leber's Disease, Retinopathy of Prematurity, Cone Rod Dystrophy, or Ocular Albinism .
3. Subject must have distance Best Corrected Visual Acuity (BCVA) measured with Early Treatment Diabetic Retinopathy Study (ETDRS) chart of between 20:60 and 20:400 in the better eye.
4. Subject must have a functional field of view of at least 20 degrees (bilateral or monocular). Field need not be centrally located.
5. If the subject is employed, they must be prepared to use eSight Eyewear in their workplace environment, have informed their employer of their involvement in the study, and received permission from their employer to bring eSight Eyewear into the workplace. If the subject is self-employed, they must be prepared to use eSight Eyewear in their workplace environment. Similarly if the subject is a student, they must be prepared to use eSight Eyewear in their educational environment.
6. Subject must be, in the opinion of the examiner, highly motivated, alert, articulate, mentally competent and able to understand and comply with the requirements of the study (defined herein).
7. Subject must provide informed consent. Subjects under the age of majority must have a legal guardian present during the informed consent process, who must sign the Informed Consent form on their behalf.
8. Subject must agree to use eSight Eyewear only under conditions that will not jeopardize the safety of either the user or the device.
Exclusion Criteria:
1. Subject must not be currently undergoing any medical or surgical procedures resulting in unstable vision.
2. Subjects for whom their vision, for whatever reason, can be considered unstable.
3. Subjects who have undergone cataract, refractive, or other surgical procedures related to vision in the six month period prior to the study.
4. Subjects who have undergone any eyesight-related injections (e.g. anti-VEGF) in the two month period prior to the study because of active bleeds in the retina. Ongoing anti-VEGF treatments are permitted if subject is in a "Treat and Extend" or pro re nata ("PRN") disease management, and macula is dry.
5. Subjects unable or unwilling to adhere to the examination schedules as they are described in the study protocol. This may also include Subjects already enrolled who, for whatever reason become unable or unwilling to continue the study. This may also include subjects for whom the travel time to/from the study site is unacceptable.
6. Subjects who self report a history of alcoholism, drug abuse or psychosis, Subjects 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.
7. Subjects who may have a conflict of interest with eSight Corp, which could reasonably influence their participation in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
75 Years
Study:
NCT02616900
Study Brief:
Protocol Section:
NCT02616900