CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 92 enrolled
Drug / intervention
iCare +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03066063
NCT03066063N/ACompleted

A New Approach to Vision Therapy Based on Naturalistic 3-D Computer Gaming

Barron Associates, Inc.·interventional·Posted Feb 28, 2017·Updated Dec 10, 2024

In Brief

A clinical study evaluating iCare, Amblyopia standard of Care, and 1 other intervention for Amblyopia and Ocular Motility Disorders. Completed, enrolled 92 participants across 1 site.

Detailed Summary

The research team will execute two concurrent studies within a common framework. The first will compare iCare to standard of care occlusion therapy (patching) for amblyopia in patients ages 4 to 18 (inclusive). The second will compare iCare to a standard of care for home-based CI therapy (pencil pushups) for convergence insufficiency patients ages 8 to 18 (inclusive). In the context of this study, the term iCare refers to either the amblyopia or CI video game module as appropriate for the respective study group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 28, 2017
Enrollment StartMay 7, 2019
Primary CompletionFeb 28, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.3 years ago

Interventions

iCaredevice

The iCare product is an action video game designed to provide home-based vision therapy for non-strabismic amblyopia and convergence insufficiency in children as young as 4 years old. Participants assigned to an iCare group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.

Amblyopia standard of Carebehavioral

The amblyopia standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily

CI standard of Carebehavioral

A dosage-matched CI standard of Care group will be prescribed pencil pushups for 20 minutes per day, five days per week.