NCT02616900

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
16 days until next milestone

Study Start

First participant enrolled

December 16, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 5, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

November 23, 2015

Results QC Date

February 6, 2019

Last Update Submit

April 3, 2019

Conditions

Vision, Low

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and after three months of device use.

Secondary Outcomes (2)

  • Improvement in Visual Acuity

    Baseline and after three months of device use.

  • Improvement in Visual Contrast Performance in Log Units.

    Baseline and after three months of device use.

Study Arms (1)

eSight Eyewear

EXPERIMENTAL

Main arm

Device: eSight Eyewear

Interventions

eSight EyewearDEVICE

primary intervention

eSight Eyewear

Eligibility Criteria

Age13 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Vitreous and Retina Consultants PA

Lakeland, Florida, 33805, United States

Location

Lighthouse For the Blind of the Palm Beaches

West Palm Beach, Florida, 33407, United States

Location

Johns Hopkins University School of Medicine, Wilmer Eye Institute

Baltimore, Maryland, 21903, United States

Location

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Université de Montréal, School of Optometry

Montreal, Quebec, H3T 1P1, Canada

Location

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Rob Hilkes
Organization
eSight Corporation
rhilkes@eSightcorp.com
613 276-4145

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2015

First Posted

November 30, 2015

Study Start

December 16, 2015

Primary Completion

March 31, 2017

Study Completion

March 31, 2017

Last Updated

April 5, 2019

Results First Posted

April 5, 2019

Record last verified: 2019-04

Locations

US(4)CA(2)