Vision, LoweQUESTNCT02616900

eSight Eyewear Quality of Life and Efficacy Study

A study testing eSight Eyewear in people with Vision, Low, run by eSight Corporation at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Vision, Low
What is being tested?: eSight Eyewear
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 6 sitesin 2 countries
Study dates: 16 Dec 2015to 31 Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 75 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Male or female subjects between the ages of 13-75.
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 .
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.
Subject must have a functional field of view of at least 20 degrees (bilateral or monocular). Field need not be centrally located.
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.
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).
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.
Subject must agree to use eSight Eyewear only under conditions that will not jeopardize the safety of either the user or the device.

Who cannot join

Subject must not be currently undergoing any medical or surgical procedures resulting in unstable vision.
Subjects for whom their vision, for whatever reason, can be considered unstable.
Subjects who have undergone cataract, refractive, or other surgical procedures related to vision in the six month period prior to the study.
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.
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.
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.
Subjects who may have a conflict of interest with eSight Corp, which could reasonably influence their participation in the study.

Trial locations and contacts

6 sites in 2 countries.

Country

City, postcode or hospital

6 sites in 2 countries

United States4 sites

University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, 48105
Johns Hopkins University School of Medicine, Wilmer Eye Institute
Baltimore, Maryland, 21903
Vitreous and Retina Consultants PA
Lakeland, Florida, 33805
Lighthouse For the Blind of the Palm Beaches
West Palm Beach, Florida, 33407

Other trials in United States

Canada2 sites

Université de Montréal, School of Optometry
Montreal, Quebec, H3T 1P1
Toronto Western Hospital
Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions: Vision, Low
Being tested: eSight Eyewear
Medical subject headings: Vision, Low

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

eSight EyewearDevice
primary intervention

Study groups in NCT02616900
Study group	Role	What they receive
eSight Eyewear	Experimental	Main arm Receives: Device: eSight Eyewear

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of Life Improvement 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.
Measured: Baseline and after three months of device use.

Secondary outcomes (2)

Improvement in Visual Acuity
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).
Measured: Baseline and after three months of device use.
Improvement in Visual Contrast Performance in Log Units.
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)
Measured: Baseline and after three months of device use.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 201531 Mar 2017

First posted30 Nov 2015 (estimated)
Study start16 Dec 2015
Primary completion31 Mar 2017
Study completion31 Mar 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vision, LowStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02616900
Sponsor's protocol ID: 00014027
Acronym: eQUEST
Status last verified: Apr 2019
First submitted: 23 Nov 2015
Last updated: 5 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vision, Low trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02616900
Acronym / sponsor ID: eQUEST / 00014027
Conditions: Vision, Low
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: eSight CorporationIndustry (pharma, biotech, devices)
Collaborators: Johns Hopkins University, Université de Montréal, University Health Network, Toronto, Vitreous and Retina Consultants PA, University of Michigan, Bascom Palmer Eye Institute
Study start: 16 Dec 2015 (actual)
Primary completion: 31 Mar 2017 (actual)
Study completion: 31 Mar 2017 (actual)
First posted: 30 Nov 2015 (estimated)
Results: Posted 5 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
eSight Eyewear	Experimental	Device: eSight EyewearMain arm

Who may qualify

Ages: 13 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Male or female subjects between the ages of 13-75.
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 .
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.
Subject must have a functional field of view of at least 20 degrees (bilateral or monocular). Field need not be centrally located.
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.

Key exclusion criteria (7 listed)

Subject must not be currently undergoing any medical or surgical procedures resulting in unstable vision.
Subjects for whom their vision, for whatever reason, can be considered unstable.
Subjects who have undergone cataract, refractive, or other surgical procedures related to vision in the six month period prior to the study.
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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
eSight Eyewearprimary intervention	Device	eSight Eyewear

Primary outcome

Quality of Life Improvement After Three Months of Device Use
Time frame: 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.

2 secondary outcomes

Improvement in Visual Acuity
Time frame: Baseline and after three months of device use.
Improvement in Visual Contrast Performance in Log Units.
Time frame: Baseline and after three months of device use.

Results and safety

Results posted to the registry on 5 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
eSight Eyewear	74	51

Primary outcome: Quality of Life Improvement After Three Months of Device Use

Time frame: Baseline and after three months of device use.. Mean (Standard Deviation). Unit: Logits

Measure	eSight Eyewear n = 51
Value	0.84 (1.265)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 54 weeks. January 20, 2016 - February 6, 2017. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
eSight Eyewear	0 of 74 (0%)	0 of 74 (0%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Cervical Cancer
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing eSight Eyewear in people with Vision, Low, run by eSight Corporation at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life Improvement After Three Months of Device Use (time frame: Baseline and after three months of device use.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02616900.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.