N/A
Completed N=92
A New Approach to Vision Therapy Based on Naturalistic 3-D Computer Gaming
amblyopia · Ocular Motility Disorders
Source: ClinicalTrials.gov NCT03066063 ↗
Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Visual Acuity — -0.12; -0.13 change in logMAR
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.
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 | — |
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. Informational only — not medical advice.