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

NCT03066063 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2024-12-10

Study results available
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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.

Conditions

  • Amblyopia
  • Ocular Motility Disorders

Interventions

DEVICE

iCare

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.

BEHAVIORAL

Amblyopia standard of Care

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

BEHAVIORAL

CI standard of Care

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

Sponsors & Collaborators

  • University of North Dakota

    collaborator OTHER

  • Barron Associates, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03066063 on ClinicalTrials.gov