N/A
N=485
Study of Binocular Computer Activities for Treatment of Amblyopia
Amblyopia
Bottom Line
View on ClinicalTrials.gov: NCT02200211 ↗Enrolled (actual)
485
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years) — 1.05; 1.35; 1.08; 1.32 LogMAR lines
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iPad® (Device); Patching 2 hours per day, 7 days per week (Other)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years) |
1.05; 1.35; 1.08; 1.32 | — |
| PRIMARY Mean Amblyopic Eye Visual Acuity (Younger Cohort) |
0.41; 0.35 | — |
| PRIMARY Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) |
3.5; 6.5; 3.7; 6.3 | 0.082 |
| PRIMARY Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) |
62.0; 62.5 | — |
| PRIMARY Distribution of Change in Amblyopic-eye Visual Acuity |
19; 29; 2; 7; 32; 36 | — |
| PRIMARY Distribution of Amblyopic-eye Visual Acuity |
2; 1; 1; 1; 2; 3 | — |
| SECONDARY Number of Participants With Amblyopic-eye VA Improvement of 2 or More logMAR Lines (10 or More Letters if E-ETDRS) From Baseline |
51; 65; 6; 17 | — |
| SECONDARY Number of Participants With Resolution of Amblyopia |
8; 18; 0; 0 | — |
| SECONDARY Time Course of Visual Acuity Improvement |
0.53; 0.76; 0.76; 1.03; 0.90; 1.21 | 0.83 |
| SECONDARY Younger Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups |
1.2; 1.4; 1.0; 1.3; 1.0; 1.3 | 0.83 |
| SECONDARY Older Cohort: Change in Distance Visual Acuity From Baseline According to Subgroups |
1.0; 6.0; 5.0; 6.8; 3.6; 6.4 | — |
| SECONDARY Distribution of Stereoacuity Scores |
1; 0; 0; 0; 62; 50 | — |
| SECONDARY Median Stereoacuity Score (Seconds of Arc) |
2000; 800; 800; 2000; 400; 400 | — |
| SECONDARY Distribution of Stereoacuity Scores (Participants With no History of Strabismus) |
1; 0; 0; 0; 23; 13 | — |
| SECONDARY Distribution of Change in Stereoacuity Scores From Baseline |
19; 24; 4; 8; 130; 122 | 0.66 |
| SECONDARY Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) |
12; 14; 2; 4; 67; 58 | 0.19 |
| SECONDARY Binocular Treatment Group: Adherence and Fellow-eye Contrast (iPad Log File Data) |
39; 5; 86; 23; 31; 3 | — |
| SECONDARY Binocular Treatment Group: Median Adherence With Prescribed Game Play (iPad Log File Data) |
46; 21 | — |
Summary
The purpose of the study is to compare the effectiveness of 1 hour/day of binocular game play 7 days per week with 2 hours/day patching 7 days per week in children 5 to <17
Eligibility Criteria
Inclusion Criteria
- Age 5 to 10∆ would require the nonius cross to be adjusted to such an extent that playing of the game would be compromised).
- Subject is able to play Hess Falling Blocks game on the study iPad® (on easy setting) under binocular conditions (with red-green glasses), as demonstrated by scoring at least 1 line in the office.
- Investigator is willing to prescribe computer game play or patching per protocol.
- Parent understands the protocol and is willing to accept randomization.
- Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff.
- Relocation outside of area of an active Pediatric Eye Disease Investigator Group (PEDIG) site for this study within the next 16 weeks is not anticipated.
Exclusion Criteria
A subject is excluded for any of the following reasons:
- Prism in the refractive correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).
- Myopia greater than -6.00 D spherical equivalent in either eye.
- Previous intraocular or refractive surgery.
- Any treatment for amblyopia (patching, atropine, Bangerter filter, or vision therapy) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks immediately prior to enrollment.
- Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above visual acuity criteria are met).
- No Down syndrome or cerebral palsy
- No severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delay or reading and/or learning disabilities are not excluded.
- Heterotropia or heterophoria with a total ocular deviation >10∆ (phoria plus tropia >10∆) at near (measured by PACT).
Data sourced from ClinicalTrials.gov (NCT02200211). 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.