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Luminopia One Pilot Study

Primary Purpose

Amblyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Luminopia One
Sponsored by
Luminopia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Major Eligibility Criteria:

  • Age 4 to <8 years (phase 1) or age 4 to <13 years (phase 2)
  • Monocular amblyopia associated with anisometropia, strabismus or both combined
  • Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive (0.3-1.0 logMAR)
  • Fellow eye BCVA 20/25 or better (phase 1) or 20/32 or better (phase 2)
  • Interocular BCVA difference ≥3 lines (≥0.3 logMAR)
  • Visual acuity stability in current refractive correction (phase 2)
  • Corrected distance heterotropia ≤5 prism diopters on simultaneous prism and cover test (SPCT)

Sites / Locations

  • Eye Physicians of Central Florida
  • Wheaton Eye Clinic
  • Indiana University
  • Kids Eye Care of Maryland
  • Children's Eye Care of Michigan
  • Concord Eye Center
  • Conestoga Eye
  • Houston Eye Associates
  • Virginia Pediatric Eye Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Regimen A

Arm Description

Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks.

Outcomes

Primary Outcome Measures

Amblyopic eye best-corrected visual acuity
Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age

Secondary Outcome Measures

Amblyopic eye best-corrected visual acuity
Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
Amblyopic eye best-corrected visual acuity
Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
Adherence
Duration spent using the device divided by duration of treatment prescribed (objectively monitored)

Full Information

First Posted
May 19, 2016
Last Updated
July 7, 2020
Sponsor
Luminopia
Collaborators
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02782117
Brief Title
Luminopia One Pilot Study
Official Title
Luminopia One Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
February 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luminopia
Collaborators
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single-arm, multi-center, open-label pilot study conducted in two phases. Phase 1 enrolled 10 participants at 1 site and phase 2 enrolled 74 participants at 9 sites.
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Regimen A
Arm Type
Experimental
Arm Description
Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks.
Intervention Type
Device
Intervention Name(s)
Luminopia One
Intervention Description
Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied.
Primary Outcome Measure Information:
Title
Amblyopic eye best-corrected visual acuity
Description
Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Amblyopic eye best-corrected visual acuity
Description
Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
Time Frame
8 weeks
Title
Amblyopic eye best-corrected visual acuity
Description
Electronic ATS-HOTV protocol for participants < 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
Time Frame
4 weeks
Title
Adherence
Description
Duration spent using the device divided by duration of treatment prescribed (objectively monitored)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Eligibility Criteria: Age 4 to <8 years (phase 1) or age 4 to <13 years (phase 2) Monocular amblyopia associated with anisometropia, strabismus or both combined Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive (0.3-1.0 logMAR) Fellow eye BCVA 20/25 or better (phase 1) or 20/32 or better (phase 2) Interocular BCVA difference ≥3 lines (≥0.3 logMAR) Visual acuity stability in current refractive correction (phase 2) Corrected distance heterotropia ≤5 prism diopters on simultaneous prism and cover test (SPCT)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hunter, MD PhD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Eye Physicians of Central Florida
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Wheaton Eye Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60187
Country
United States
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
Kids Eye Care of Maryland
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21703
Country
United States
Facility Name
Children's Eye Care of Michigan
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Concord Eye Center
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Conestoga Eye
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Virginia Pediatric Eye Center
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Luminopia One Pilot Study

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