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Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

NCT06380517 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2026-02-11

No results posted yet for this study

Summary

In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.

Conditions

  • Amblyopia

Interventions

DEVICE

Luminopia

dichoptic movies/shows shown through a virtual reality headset

OTHER

Eye Patch

Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Pediatric Eye Disease Investigator Group

    collaborator NETWORK

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Aparna Raghuram, OD, PhD · Boston Children's Hospital/ Harvard Medical School

  • Kammi Gunton, MD · Wills Eye Hospital

  • Robert Henderson, MS · Jaeb Center for Health Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2027-07-01
Completion
2028-01-01
FDA Device
Yes

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 NCT06380517 on ClinicalTrials.gov