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Dichoptic treatment for amblyopia in young children

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

Phase 3 Interventional Jaeb Center for Health Research · NCT06380517

This study is testing a new headset treatment for lazy eye in kids aged 4 to 7 to see if it works better than the usual patching method.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment238 (estimated)
Ages4 Years to 7 Years
SexAll
SponsorJaeb Center for Health Research Academic / other
Locations73 sites (Birmingham, Alabama and 72 other locations)
Trial IDNCT06380517 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a novel dichoptic treatment using the Luminopia headset compared to traditional patching therapy for amblyopia in children aged 4 to 7. Participants will be randomly assigned to either watch dichoptic movies for 1 hour a day or undergo patching treatment for 2 hours a day over a 26-week period. The primary outcome will assess changes in visual acuity in the amblyopic eye, with follow-up assessments at 13 and 26 weeks. If patching treatment is ineffective, participants will be offered the dichoptic therapy for further evaluation.

Who should consider this trial

Good fit: Ideal candidates are children aged 4 to 7 years with amblyopia and a significant interocular difference in visual acuity.

Not a fit: Patients with amblyopia who do not meet the specified visual acuity criteria or have other ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more engaging and effective alternative to traditional patching for children with amblyopia.

How similar studies have performed: Previous studies have shown promise in using dichoptic treatments for amblyopia, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study.

1. Age 4 to 7 years.
2. Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV VA protocol on a study-approved device displaying single surrounded optotypes, as follows:

   1. VA in the amblyopic eye 20/40 to 20/200 inclusive.
   2. Age-normal VA in the fellow eye:44,45

      • 4 years: 20/40 or better; 5-6 years: 20/32 or better; 7 years: 20/25 or better
   3. Interocular difference ≥ 3 logMAR lines (i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).
3. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).

   1. Criteria for strabismic amblyopia: At least one of the following must be met:

      * 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

   NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles).
   1. Spectacles/contact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:

      * 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.

Individuals meeting any of the following criteria will be excluded from study participation.

1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)
2. Prism lenses or need of a prism prescription at enrollment.
3. Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).
4. Myopia greater than -6.00D spherical equivalent in either eye.
5. Previous intraocular or refractive surgery.
6. Known skin reactions to patch or bandage adhesives.
7. Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met using patch occlusion. Fogging is not permitted).
8. Diplopia more than once per week over the last week prior to enrollment by parental report.
9. History of light-induced seizures.
10. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
11. Participation in a prior study involving patching for amblyopia
12. Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.

Where this trial is running

Birmingham, Alabama and 72 other locations

+23 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AmblyopiaDichopticLuminopiaPatchingmovie
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.