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N/A N=485 Randomized Single-blind Treatment

Study of Binocular Computer Activities for Treatment of Amblyopia

Amblyopia

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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