eQUEST: eSight Eyewear Quality of Life and Efficacy Study

• Sponsor: eSight Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02616900
• Collaborator: Johns Hopkins University (Other), Université de Montréal (Other), University Health Network, Toronto (Other), Vitreous and Retina Consultants PA (Other), University of Michigan (Other), Bascom Palmer Eye Institute (Other)
• Enrollment: 74
• Locations: 6
• Arm: 1
• Actual Duration (Months): 15.5
• Patients Per Site: 12.3
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vision, Low	Device: eSight Eyewear	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 74 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: 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
• Actual Study Start Date: Dec 16, 2015
• Actual Primary Completion Date: Mar 31, 2017
• Actual Study Completion Date: Mar 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: eSight Eyewear Main arm	Device: eSight Eyewear; primary intervention

Outcome Measures

Primary Outcome Measures

1. Quality of Life Improvement After Three Months of Device Use [Baseline and after three months of device use.]

   The study seeks to quantify, after a period of usage of the device of three months, improvement in subjects' Quality of Life using the validated tool, "Veterans Affairs (VA) Low Vision (LV) Visual Functioning Questionnaire (VFQ) - 48 Questions" (VA LV VFQ-48). Quality of Life is measured in Logits. Individual scores ranged from -5 to +10 (a higher number is a better score). Overall improvement was 0.84 Logits.

Secondary Outcome Measures

1. Improvement in Visual Acuity [Baseline and after three months of device use.]

   The study seeks to quantify, after a period of usage of the device of three months, improvement in visual acuity using standard optometric charts (e.g. "20/400 to 20/160", etc.). We measured LogMAR acuity on a standard ETDRS chart. Results show an average greater than seven-line improvement (-0.76 LogMAR).

2. Improvement in Visual Contrast Performance in Log Units. [Baseline and after three months of device use.]

   The study seeks to quantify, after a period of usage of the device of three months, improvement in contrast performance using a standard optometric "Mars Contrast Chart". Outcome is measured in Log Units ranging from 0.04 to 1.92 in decrements of 0.04 log units, a higher score indicating better contrast performance. The scale of the Mars Contrast Chart is interpreted as follows: 0.0 - 0.5 Log Units: Profound Loss 0.5 - 1.0 Log Units: Severe Loss 1.0 - 1.5 Log Units: Moderate Loss 1.5 - 1.75 Log Units: Normal Vision (>60yrs) >1.75 Log Units: Normal Vision (<60yrs)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vitreous and Retina Consultants PA	Lakeland	Florida	United States	33805
2	Lighthouse For the Blind of the Palm Beaches	West Palm Beach	Florida	United States	33407
3	Johns Hopkins University School of Medicine, Wilmer Eye Institute	Baltimore	Maryland	United States	21903
4	University of Michigan Kellogg Eye Center	Ann Arbor	Michigan	United States	48105
5	Toronto Western Hospital	Toronto	Ontario	Canada	M5T 2S8
6	Université de Montréal, School of Optometry	Montréal	Quebec	Canada	H3T 1P1

Sponsors and Collaborators

• eSight Corporation
• Johns Hopkins University
• Université de Montréal
• University Health Network, Toronto
• Vitreous and Retina Consultants PA
• University of Michigan
• Bascom Palmer Eye Institute

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 21, 2016

More Information

Publications

None provided.

• Responsible Party: eSight Corporation
• ClinicalTrials.gov Identifier: NCT02616900
• Other Study ID Numbers: 00014027
• First Posted: Nov 30, 2015
• Last Update Posted: Apr 5, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Vision, Low

Study Results

Participant Flow

Recruitment Details	51 participants selected from the patient population at six low vision rehabilitation clinics, in the period Dec 16, 2015 through September 19, 2016.
Pre-assignment Detail	The study had only one arm.

Arm/Group Title	eSight Eyewear
Arm/Group Description	Main arm eSight Eyewear: primary intervention
Period Title: Overall Study
STARTED	74
Completed 3mo Trial	57
COMPLETED	51
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	eSight Eyewear
Arm/Group Description	Main arm eSight Eyewear: primary intervention
Overall Participants	51
Age (Count of Participants)
<=18 years	3 5.9%
Between 18 and 65 years	39 76.5%
>=65 years	9 17.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48 (17.2)
Sex: Female, Male (Count of Participants)
Female	21 41.2%
Male	30 58.8%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Quality of Life Improvement After Three Months of Device Use
Description	The study seeks to quantify, after a period of usage of the device of three months, improvement in subjects' Quality of Life using the validated tool, "Veterans Affairs (VA) Low Vision (LV) Visual Functioning Questionnaire (VFQ) - 48 Questions" (VA LV VFQ-48). Quality of Life is measured in Logits. Individual scores ranged from -5 to +10 (a higher number is a better score). Overall improvement was 0.84 Logits.
Time Frame	Baseline and after three months of device use.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSight Eyewear
Arm/Group Description	Main arm eSight Eyewear: primary intervention
Measure Participants	51
Mean (Standard Deviation) [Logits]	0.84 (1.265)

2. Secondary Outcome

Title	Improvement in Visual Acuity
Description	The study seeks to quantify, after a period of usage of the device of three months, improvement in visual acuity using standard optometric charts (e.g. "20/400 to 20/160", etc.). We measured LogMAR acuity on a standard ETDRS chart. Results show an average greater than seven-line improvement (-0.76 LogMAR).
Time Frame	Baseline and after three months of device use.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSight Eyewear
Arm/Group Description	Main arm eSight Eyewear: primary intervention
Measure Participants	51
Mean (Standard Deviation) [LogMAR]	-0.76 (0.30)

3. Secondary Outcome

Title	Improvement in Visual Contrast Performance in Log Units.
Description	The study seeks to quantify, after a period of usage of the device of three months, improvement in contrast performance using a standard optometric "Mars Contrast Chart". Outcome is measured in Log Units ranging from 0.04 to 1.92 in decrements of 0.04 log units, a higher score indicating better contrast performance. The scale of the Mars Contrast Chart is interpreted as follows: 0.0 - 0.5 Log Units: Profound Loss 0.5 - 1.0 Log Units: Severe Loss 1.0 - 1.5 Log Units: Moderate Loss 1.5 - 1.75 Log Units: Normal Vision (>60yrs) >1.75 Log Units: Normal Vision (<60yrs)
Time Frame	Baseline and after three months of device use.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	eSight Eyewear
Arm/Group Description	Main arm eSight Eyewear: primary intervention
Measure Participants	51
Mean (Standard Deviation) [Log Units]	0.53 (0.55)

Adverse Events

Time Frame	54 weeks. January 20, 2016 - February 6, 2017
Adverse Event Reporting Description	All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were monitored/assessed, but none observed. We define an adverse event as any event whereby patient health or safety is adversely affected in any manner by the study device.
Arm/Group Title	eSight Eyewear
Arm/Group Description	Main arm eSight Eyewear: primary intervention
All Cause Mortality
	eSight Eyewear
	Affected / at Risk (%)	# Events
Total	0/74 (0%)
Serious Adverse Events
	eSight Eyewear
	Affected / at Risk (%)	# Events
Total	0/74 (0%)
Other (Not Including Serious) Adverse Events
	eSight Eyewear
	Affected / at Risk (%)	# Events
Total	0/74 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.