Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
ConditionAmblyopia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age4-7
SponsorJaeb Center for Health Research
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 4 to 7 years.
VA in the amblyopic eye 20/40 to 20/200 inclusive.
Age-normal VA in the fellow eye:44,45
Interocular difference ≥ 3 logMAR lines (i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Luminopia
Devicedichoptic movies/shows shown through a virtual reality headset
Eye Patch
Other interventionProcedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye
Treatment groups
238 Participants
are divided into 2 treatment groupsGroup A: Luminopia GroupExperimental treatment 1 intervention
Group B: Patching GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in amblyopic eye logMAR distance VA between randomization and 26 weeks
Time frame
26 WeeksSponsors and contacts
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Jaeb Center for Health Research
Lead sponsor
National Eye Institute (NEI)
Collaborator
Pediatric Eye Disease Investigator Group
Collaborator
Source ClinicalTrials.gov