eSight Eyewear Quality of Life and Efficacy Study



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:13 - 75
Updated:4/6/2019
Start Date:December 16, 2015
End Date:March 31, 2017

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eQUEST -- ESIGHT QUALITY OF LIFE AND EFFICACY STUDY A Multi-center, Prospective Cohort Study to Assess the Impact of eSight Eyewear on Functional Vision Improvement and Quality of Life in a Low Vision Population

The "eSight Quality of Life and Efficacy Study" (eQUEST) is a prospective cohort study
intended to demonstrate the functional vision and Quality of Life (QoL) improvement provided
by eSight Eyewear to persons with significant visual impairment resulting from various eye
conditions. The multi-site study will evaluate the efficacy of the eSight device for various
Activities of Daily Living (ADLs) across a broad range of subject ages and disease types.

Subjects will receive an initial benchmark assessment to determine their visual function.
This includes standard clinical tests for acuity and contrast performance. Subjects will then
receive a demonstration of the device. If the demonstration shows favourable results
(improved functional visual performance for some rudimentary tasks such as reading), and the
subject consents to the study, the subject will return to the site a week later to receive
their personalized device (lens prescriptions incorporated into the unit), and more
comprehensive training on its operation. They will then use the unit in their
home/work/school environment over a period of three months. At the start of the study, after
a period of one month, and at the end of the three month period, the subject will visit the
clinical setting for administration of various specified ADL tasks, and the Veterans Affairs
(VA) Low Vision (LV) Visual Function Questionnaire (VFQ) 48-question VA LV VFQ-48 survey. The
intent of this repetition is to understand how ADL proficiency and VFQ-48 QoL assessment
changes over time, as the subject becomes more accustomed to the device.

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.
We found this trial at
5
sites
Ann Arbor, Michigan 48105
Principal Investigator: Kanishka Jayasundera, MD
Phone: 734-936-9798
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Ann Arbor, MI
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Baltimore, Maryland 21903
Principal Investigator: Judith Goldstein, OD
Phone: 410-955-0580
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Baltimore, MD
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Lakeland, Florida 33805
Phone: 863-297-5400
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Lakeland, FL
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Toronto, Ontario
Principal Investigator: Samuel N Markowitz, MD, FRCS
Phone: (416) 531-5425
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Toronto,
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West Palm Beach, Florida 33407
Phone: 305-326-6136
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West Palm Beach, FL
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