Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age

Recruiting now · Phase 3

Conditions studied: Amblyopia

In brief

Participants eligible for the study will be randomly allocated (1:1:1) to receive either Luminopia dichoptic treatment while wearing optical correction if needed, Vivid Vision dichoptic treatment while wearing optical correction if needed, or continued optical correction alone if needed, with clinical assessments at 9- and 18-weeks post-randomization. At the 18-week primary outcome visit, participants who were randomly assigned to receive optical correction alone if needed with an IOD of 1 logMAR line (5 letters) or more, will be offered randomization to Luminopia or Vivid Vision dichoptic therapy and if they accept, followed forward with visits at 27- and 36-weeks post-randomization. The study will end for all other participants at 18 weeks.

Key facts

Study ID

NCT06524882

Run by

Jaeb Center for Health Research

People needed

252

Starts

2024-10-22

Expected to finish

2027-11-01

Last updated by the study team

2026-02-11

Who can join

Age: 8 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 8 to <13 years.
• VA, measured in each eye without cycloplegia in current refractive correction (if applicable) using the E-ETDRS VA protocol on a study-approved device displaying single surrounded optotypes, as follows:
• VA in the amblyopic eye 20/40 to 20/200 inclusive (33 to 72 letters with E-ETDRS).
• VA in the fellow eye 20/25 or better (≥ 78 letters with E-ETDRS).
• Interocular difference ≥ 3 logMAR lines (≥ 15 letters) i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).
• Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).
• 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.
• Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia).
• 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.
• 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.
• No more than 2 weeks (cumulative) of prior dichoptic treatment
• No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.
• 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: Children with cycloplegic refractive errors that do not fall within the requirements above for refractive correction may be given refractive correction at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.
• 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).
• Spectacles/contact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:

You may not qualify if…

• Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)
• Prism greater than a total of 8 diopters horizontal and 1 diopter vertical in the refractive correction at time of enrollment.
• Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).
• Myopia greater than -6.00D spherical equivalent in either eye.
• 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).
• Diplopia more than once per week over the last week prior to enrollment by parental report.
• History of light-induced seizures.
• Known simulator sickness.
• 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.
• 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 it is running

• Midwestern University Eye Institute — Glendale, Arizona, United States (enrolling)
• Phoenix Children's Medical Group - Ophthalmology — Scottsdale, Arizona, United States (enrolling)
• University of Arizona — Tucson, Arizona, United States (enrolling)
• Arkansas Childrens — Little Rock, Arkansas, United States (enrolling)
• McFarland Eye Care Center — Little Rock, Arkansas, United States (enrolling)
• University Eye Center at Ketchum Health — Anaheim, California, United States (enrolling)
• Univ. of California- Berkeley — Berkeley, California, United States (enrolling)
• Univ of California, Irvine- Gavin Herbert Eye Institute — Irvine, California, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• Western University College of Optometry — Pomona, California, United States (enrolling)
• University of California, Davis — Sacramento, California, United States (enrolling)
• University of California San Francisco Department of Ophthalmology — San Francisco, California, United States (enrolling)
• Nova Southeastern University College of Optometry, The Eye Institute — Fort Lauderdale, Florida, United States (enrolling)
• University of South Florida (USF) Eye — Tampa, Florida, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Illinois College of Optometry — Chicago, Illinois, United States (enrolling)
• Midwestern University Eye Institute — Downers Grove, Illinois, United States (enrolling)
• Progressive Eye Care — Lisle, Illinois, United States (enrolling)
• Indiana School of Optometry — Bloomington, Indiana, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• University of Kansas Dept of Ophthalmology — Prairie Village, Kansas, United States (enrolling)
• Greater Baltimore Medical Center — Baltimore, Maryland, United States (enrolling)
• Wilmer Eye Institute — Baltimore, Maryland, United States (enrolling)
• New England College of Optometry — Boston, Massachusetts, United States (enrolling)
• UAB Pediatric Eye Care; Birmingham Health Care — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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