N/A
N=320
Binocular Dig Rush Game Treatment for Amblyopia
Amblyopia
Bottom Line
View on ClinicalTrials.gov: NCT02983552 ↗Enrolled (actual)
320
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort — 1.3; 1.7; 1.3; 1.7 Letter score — p=0.71
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iPad® (Other); Spectacle correction (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Jaeb Center for Health Research
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort |
1.3; 1.7; 1.3; 1.7 | 0.71 |
| PRIMARY Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort) |
25.9; 27.7 | — |
| PRIMARY Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort |
2.3; 2.4; 2.3; 2.4 | — |
| PRIMARY Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort) |
25.9; 27.7 | — |
| PRIMARY Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort |
1.0724; 0.6053; 1.0706; 0.6071 | — |
| PRIMARY Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort) |
0.36; 0.38 | — |
| PRIMARY Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort |
1.2614; 0.9855; 1.2588; 0.9981 | — |
| PRIMARY Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort) |
0.36; 0.38 | — |
| SECONDARY VA Improvement at 4 Weeks Defined as a Binary Outcome |
2; 3; 31; 16 | — |
| SECONDARY VA Improvement at 8 Weeks Defined as a Binary Outcome |
5; 6; 35; 25 | — |
| SECONDARY Distribution of Stereoacuity Scores at 4 Weeks |
0; 0; 6; 8; 31; 25 | — |
| SECONDARY Distribution of Change in Stereoacuity Scores From Baseline |
6; 3; 8; 3; 53; 51 | 0.53 |
| SECONDARY Distribution of Stereoacuity Scores at 8 Weeks |
31; 24; 28; 25; 11; 10 | — |
| SECONDARY Distribution of Change in Stereoacuity Scores From Baseline |
6; 3; 8; 3; 53; 51 | 0.53 |
| SECONDARY Distribution of Stereoacuity Scores (Participants With no History of Strabismus) |
8; 8; 14; 11; 3; 7 | — |
| SECONDARY Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) |
3; 0; 5; 4; 19; 31 | 0.74 |
| SECONDARY Distribution of Stereoacuity Scores (Participants With no History of Strabismus) |
8; 8; 14; 11; 3; 7 | — |
| SECONDARY Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus) |
3; 0; 5; 4; 19; 31 | 0.74 |
| SECONDARY Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast |
38; 35; 59; 50; 1; 2 | — |
| SECONDARY Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast |
38; 35; 59; 50; 1; 2 | — |
| SECONDARY Treatment Compliance With Spectacle Wear |
61; 62; 69; 78 | — |
| SECONDARY Treatment Compliance With Spectacle Wear |
61; 62; 69; 78 | — |
| SECONDARY Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort) |
0.1; 1.1; 0.1; 1.1 | — |
| SECONDARY Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort) |
0.5; 1.5; 0.5; 1.5 | — |
| SECONDARY Ocular Alignment at 4 Weeks |
10; 6; 7; 7 | 0.37 |
| SECONDARY Ocular Alignment at 8 Weeks |
9; 9; 6; 7 | 0.99 |
| SECONDARY Distribution of Diplopia Frequency at 4 Weeks (Participant-reported) |
62; 64; 78; 79; 1; 0 | 0.20 |
| SECONDARY Distribution of Diplopia Frequency at 8 Weeks (Participant-reported) |
63; 65; 78; 78; 5; 2 | >0.99 |
| SECONDARY Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported) |
3; 2; 6; 2; 64; 64 | 0.44 |
| SECONDARY Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported) |
0; 1; 2; 1; 64; 66 | >0.99 |
| SECONDARY Distribution of Diplopia Frequency at 4 Weeks (Parent-reported) |
65; 66; 87; 83; 3; 0 | 0.12 |
| SECONDARY Distribution of Diplopia Frequency at 8 Weeks (Parent-reported) |
66; 67; 84; 84; 1; 1 | >0.99 |
| SECONDARY Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported) |
0; 0; 0; 0; 69; 66 | 0.12 |
| SECONDARY Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported) |
0; 0; 0; 0; 67; 68 | >0.99 |
| SECONDARY Frequency of Adverse Symptoms (Symptom Survey) |
61; 57; 72; 71; 3; 8 | — |
| SECONDARY Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks |
58; 61; 74; 62; 7; 4 | — |
| SECONDARY Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks |
1; 1; 4; 0; 62; 59 | 0.07 |
| SECONDARY Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks |
1; 2; 4; 2; 61; 57 | 0.06 |
| SECONDARY Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort) |
0.0536; 0.1939; 0.0682; 0.1786 | — |
| SECONDARY Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort) |
0.3160; 0.2122; 0.3256; 0.2024 | — |
Summary
To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age.
Eligibility Criteria
Inclusion Criteria
- Age 4 to 1.00D.
- Myopia must not be undercorrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes.
- Spectacle correction meeting the above criteria must be worn:
- For at least 16 weeks OR until VA stability is documented (defined as 5∆ are not allowed because large magnitudes of the deviation would compromise successful playing of the game.)
- Subject is able to play the Dig Rush game (at least level 3) on the study iPad under binocular conditions (with red-green glasses). Subject must be able to see both the red "diggers" and blue "gold carts" when contrast for the non-amblyopic eye is at 20%.
- Investigator is willing to prescribe computer game play, or continued spectacle wear 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 or other study staff.
- Relocation outside of area of an active PEDIG site for this study within the next 8 weeks is not anticipated.
Exclusion Criteria
- Prism in the spectacle correction at time of enrollment (eligible only if prism is discontinued 2 weeks prior to enrollment).
- Myopia greater than -6.00D spherical equivalent in either eye.
- Previous intraocular or refractive surgery.
- Any treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy or previous binocular treatment) during the past 2 weeks. Previous amblyopia therapy is allowed regardless of type, but must be discontinued at least 2 weeks prior to enrollment.
- Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the subject if the above VA 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.
- Subject has demonstrated previous low compliance with binocular treatment and/or spectacle treatment (as assessed informally by the investigator)
Data sourced from ClinicalTrials.gov (NCT02983552). 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.