Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
This study is looking into new ways to treat amblyopia, also known as "lazy eye," in children aged 8 to 12. It compares two virtual reality (VR) treatments, Vivid Vision (which uses video games) and Luminopia (which uses movies/shows), against standard glasses. The goal is to see if these VR treatments can improve vision in the amblyopic eye. Participants will be randomly assigned to one of the three groups, and researchers will measure changes in vision after 18 weeks. The study is currently unclear on its recruitment status.
- Study design
- This is an interventional study with 252 planned participants, randomly assigned to one of three groups.
- What's involved
- Participants will have clinical assessments at 9 and 18 weeks after being assigned to a treatment group. Some participants may continue with visits at 27 and 36 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Most participants will be followed for 18 weeks, with some potentially followed for up to 36 weeks after randomization.
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NCT06524882
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Recruiting
PHASE3Ages 8–12InterventionalTreatmentJaeb Center for Health ResearchInvestigator-initiated
~252 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:Vivid VisionLuminopiaOptical Correction
At a glance
Recruiting sites
58 of 58 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in amblyopic eye logMAR distance VA
Measured over 18 Weeks
Conditions
Where it's being run
58 sites across 26 statesCalifornia7
Illinois4
Minnesota4
Ohio4
Pennsylvania4
Texas4
Arizona3
Massachusetts3
Study leadership
- Marjean T Kulp, OD · STUDY_CHAIR · Ohio State University
- Benajmin G Jastrzembski, MD · STUDY_CHAIR · University of California, Davis
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.
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 SE 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 \<1-line 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 a headset. 8. Participant is willing to continue full-time spectacles/contact lens wear (if needed). 9. Interpupillary distance of 52mm to 72mm inclusive. 10. Investigator is willing to prescribe continued spectacles/contact lens correction (if needed) or either dichoptic device per protocol. 11. Participant is willing to accept assignment to either continued spectacles/ contact lens wear alone, dichoptic movies/shows (view 1 hour per day 6 days per week) OR dichoptic games (play approximately 25 minutes per day, 6 days per week) for 19 weeks. 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 staff. 14. Relocation outside of area of an active PEDIG site for this study within the next 36 weeks is not anticipated.
What this trial measures
- Change in amblyopic eye logMAR distance VA18 Weeks
between randomization and 18 weeks