Dichoptic Treatment for Amblyopia in Children
This study is looking at new ways to treat amblyopia (sometimes called "lazy eye") in children aged 4 to 7 years old. It compares two treatments: watching special movies/shows through a virtual reality headset called Luminopia, or using an eye patch. The main goal is to see if Luminopia is as effective as patching in improving vision in the amblyopic eye over 26 weeks. To join, children must be between 4 and 7 years old and meet specific vision requirements. The study is currently recruiting 238 participants, but its exact status is unclear.
- Study design
- This study is interventional and will randomly assign participants to either the Luminopia headset group or the eye patch group. It plans to enroll 238 children.
- What's involved
- Participants will have clinical assessments at 13 and 26 weeks after starting treatment. Some participants may continue with visits at 39 and 52 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed for 26 weeks, with some continuing for up to 52 weeks after randomization.
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NCT06380517
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Recruiting
PHASE3Ages 4–7InterventionalTreatmentJaeb Center for Health ResearchInvestigator-initiated
~238 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:LuminopiaEye Patch
At a glance
Recruiting sites
73 of 73 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in amblyopic eye logMAR distance VA between randomization and 26 weeks
Measured over 26 Weeks
Conditions
Where it's being run
73 sites across 29 statesCalifornia10
Ohio6
Michigan5
Illinois4
Massachusetts4
Minnesota4
Pennsylvania4
Arizona3
Study leadership
- Aparna Raghuram, OD, PhD · STUDY_CHAIR · Boston Children's Hospital/ Harvard Medical School
- Kammi Gunton, MD · STUDY_CHAIR · Wills Eye Hospital
- Robert Henderson, MS · PRINCIPAL_INVESTIGATOR · Jaeb Center for Health Research
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Presence of a heterotropia on examination at distance or near fixation (with optical correction), must be \<=5 prism diopters (∆) by SPCT at distance and near fixation (see #7 below).
Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia). 2. Criteria for anisometropia: At least one of the following criteria must be met:
≥1.00 D difference between eyes in spherical equivalent (SE).
≥1.50 D difference in astigmatism between corresponding meridians in the two eyes. 3. Criteria for combined-mechanism: Both of the following criteria must be met:
A criterion for strabismus is met (see above).
≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes. 4. No more than 2 weeks (cumulative) of prior dichoptic treatment. 5. No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued. 6. Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months:
Hypermetropia of 2.50 D or more by SE
Myopia of amblyopic eye of 0.50D or more SE
Astigmatism of 1.00D or more
Anisometropia of more than 0.50D SE
SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes).
SE must not be under corrected by more than 1.50D SE.
Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.
Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is \>1.00D.
Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes. 2. Spectacles/contact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn:
For at least 18 weeks OR until VA stability is documented (defined as \<0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 9 weeks apart).
For determining VA stability (non-improvement):
The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),
The second measurement must be made without cycloplegia in the correct spectacles/contact lens correction that has been worn for at least 9 weeks.
NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated. 7. Participant is willing to wear the Luminopia headset. 8. Participant is willing to continue full-time spectacles/contact lens wear (if needed). 9. Participant is willing to accept assignment to either dichoptic shows (view 1 hour per day 6 days per week) OR part-time patching (2 hours per day 7 days per week) for 26 weeks. 10. Interpupillary distance of 52mm to 72mm inclusive. 11. Investigator is willing to prescribe Luminopia or patching per protocol. 12. Parent understands the protocol and is willing to accept randomization. 13. Parent has phone (or access to phone) and is willing to be contacted by JAEB Center. 14. Relocation outside area of active PEDIG site within the next 52 weeks is not anticipated.
What this trial measures
- Change in amblyopic eye logMAR distance VA between randomization and 26 weeks26 Weeks