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
Qualifiers
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
Treatments tested in this trial
- Luminopia
- Eye Patch
Treatment groups
238 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jaeb Center for Health Research
Lead sponsor
National Eye Institute (NEI)
Collaborator
Pediatric Eye Disease Investigator Group
Collaborator
Source ClinicalTrials.gov