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Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

NCT06524882 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2026-02-11

No results posted yet for this study

Summary

Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization.

At the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization.

The study will end for all other participants at 18 weeks.

Conditions

  • Amblyopia

Interventions

DEVICE

Vivid Vision

dichoptic video games played through a virtual reality headset

DEVICE

Luminopia

dichoptic movies/shows shown through a virtual reality headset

DEVICE

Optical Correction

Glasses prescribed at investigator discretion

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Pediatric Eye Disease Investigator Group

    collaborator NETWORK

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Marjean T Kulp, OD · Ohio State University

  • Benajmin G Jastrzembski, MD · University of California, Davis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2027-07-01
Completion
2027-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524882 on ClinicalTrials.gov