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

ConditionAmblyopia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age8-12
SponsorJaeb Center for Health Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 8 to <13 years.

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vivid Vision

    Device

    dichoptic video games played through a virtual reality headset

  • Luminopia

    Device

    dichoptic movies/shows shown through a virtual reality headset

  • Optical Correction

    Device

    Glasses prescribed at investigator discretion

Treatment groups

252 Participants
are divided into 3 treatment groups
Group A: Luminopia GroupExperimental treatment 1 intervention
Group B: Vivid Vision GroupExperimental treatment 1 intervention
Group C: Continued Optical Correction GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in amblyopic eye logMAR distance VA

between randomization and 18 weeks

Time frame
18 Weeks

Secondary outcomes

1

Functional Vision, Social, and Frustration/Worry quality of life domains as measured by the Pediatric Eye Questionnaire (PedEyeQ).

Questionnaire outcome

Time frame
18 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jaeb Center for Health Research

Lead sponsor

National Eye Institute (NEI)

Collaborator

Pediatric Eye Disease Investigator Group

Collaborator

Source ClinicalTrials.gov
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