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

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

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.

Participants eligible for the study will be randomly allocated (1:1) to receive either dichoptic treatment while wearing the Luminopia headset or patching treatment of the fellow eye for amblyopia with clinical assessments at 13, and 26-weeks post-randomization.

At the 26-week primary outcome visit, participants who were randomly assigned to receive patching treatment with an IOD of 1 logMAR line or more, will be offered Luminopia dichoptic therapy and if they accept, followed forward with visits at 39- and 52-weeks post-randomization.

The study will end for all other participants.

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.