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Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age — ATS23  

Amblyopia Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06380517
Study type Interventional
Source Jaeb Center for Health Research
Contact Raymond T Kraker, MSPH
Phone 813-975-8690
Email rkraker@jaeb.org
Status Not yet recruiting
Phase N/A
Start date May 1, 2024
Completion date May 1, 2027
View Details
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