N/A
N=92
A New Approach to Vision Therapy Based on Naturalistic 3-D Computer Gaming
Amblyopia · Ocular Motility Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03066063 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Visual Acuity — -0.12; -0.13 change in logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iCare (Device); Amblyopia standard of Care (Behavioral); CI standard of Care (Behavioral)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Barron Associates, Inc.
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
-0.12; -0.13 | — |
| PRIMARY Positive Fusional Vergence (PFV) Base-Out Breakpoint (BOB) |
4.85; 6.22 | — |
| SECONDARY Near Point of Convergence (NPC) at Break |
-4.92; -3.63 | — |
| SECONDARY Convergence Insufficiency Symptom Survey (CISS) |
-12.00; -9.00 | — |
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.
Eligibility Criteria
Inclusion Criteria (Amblyopia Arms):
- Age 4 to 18 (inclusive);
- Diagnosis of amblyopia associated with anisometropia;
- No amblyopia treatment (atropine, patching, vision therapy) in the past two weeks;
- Spectacles (if required) worn for at least 16 weeks, or demonstrated stability of visual acuity ( 10∆ at near.
Inclusion Criteria (CI Arms):
- Best-corrected visual acuity of ≥ 20/25 in each eye at distance and near;
- Exophoria at near at least 4∆ greater than at distance;
- Reduced positive fusional convergence at near ( 20cm in the right eye;
- Manifest or latent nystagmus clinically evident;
- Down syndrome, cerebral palsy, or other severe developmental delay, or learning or attention disability that in the investigator's discretion will interfere with treatment or evaluation;
- Acquired brain injury;
- Previous vision therapy treatment for CI within the previous 6 months.
Data sourced from ClinicalTrials.gov (NCT03066063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.