Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Luminopia One Amblyopia Vision Improvement Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03608150
Recruitment Status : Completed
First Posted : July 31, 2018
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Luminopia

Brief Summary:
The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.

Condition or disease Intervention/treatment Phase
Amblyopia Device: Luminopia One Device: Refractive Correction Not Applicable

Detailed Description:
The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Luminopia One Amblyopia Vision Improvement Study
Actual Study Start Date : January 16, 2019
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arm Intervention/treatment
Experimental: Therapeutic Group
Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.
Device: Luminopia One
Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.

Active Comparator: Control Group
Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.
Device: Refractive Correction
Standard of care refractive correction (ex. spectacles)




Primary Outcome Measures :
  1. Best-Corrected Visual Acuity of Amblyopic Eye [ Time Frame: 12 weeks ]
    Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.

  2. Best-Corrected Visual Acuity of Fellow Eye [ Time Frame: 12 weeks ]
    Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.


Secondary Outcome Measures :
  1. Adherence [ Time Frame: 4, 8, and 12 weeks ]
    Mean adherence with the therapeutic in treatment group.

  2. Best-Corrected Visual Acuity of Amblyopic Eye [ Time Frame: 4 and 8 weeks ]
    Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 and 8 weeks using electronic ATS-HOTV protocol.

  3. Stereoacuity [ Time Frame: 4, 8, and 12 weeks ]
    Mean stereoacuity improvement from baseline after 4, 8, and 12 weeks.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 4 to 7 years at the time of consent.
  • Amblyopia associated with anisometropia and/or mild strabismus.
  • Current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logMAR lines.
  • Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive.
  • Fellow eye BCVA 20/32 or better.
  • Interocular difference ≥ 3 logMAR lines.
  • Heterotropia ≤ 5 prism diopters in current refractive correction at distance measured by SPCT.

Exclusion Criteria:

  • Atropine treatment in the past 2 weeks.
  • Prior amblyopia treatment (other than refractive correction) for > 12 months in total.
  • High myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay.
  • History of low adherence with amblyopia treatment or light-induced seizures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608150


Locations
Show Show 22 study locations
Sponsors and Collaborators
Luminopia
Investigators
Layout table for investigator information
Study Director: Scott Xiao Luminopia
  Study Documents (Full-Text)

Documents provided by Luminopia:
Study Protocol  [PDF] October 8, 2018

Layout table for additonal information
Responsible Party: Luminopia
ClinicalTrials.gov Identifier: NCT03608150    
Other Study ID Numbers: C-AM-2
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases