Binocular Dig Rush Game Treatment for Amblyopia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 320
- Locations
- 111
- Primary Endpoint
- Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort
Study Overview
Brief 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.
Detailed Description
The purpose of the study is 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 4 to <13 years
- •Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated)
- •Criteria for strabismic amblyopia: At least one of the following must be met:
- •Presence of a heterotropia on examination at distance or near fixation (with or without optical correction, must be no more than 5pd by SPCT at near fixation (see #6 below)
- •Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
- •Criteria for anisometropia: At least one of the following criteria must be met:
- •≥1.00 D difference between eyes in spherical equivalent
- •≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
- •Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:
- •Criteria for strabismus are met (see above)
- •≥1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
- •No amblyopia treatment other than optical correction in the past 2 weeks (patching, atropine, Bangerter, vision therapy, binocular treatment)
- •Requirements for required refractive error correction (based on a cycloplegic refraction completed within the last 7 months):
- •Hypermetropia of 2.50 D or more by spherical equivalent (SE)
- •Myopia of amblyopic eye of 0.50D or more SE
- •Astigmatism of 1.00D or more
- •Anisometropia of more than 0.50D SE
- •NOTE: Subjects with cycloplegic refractive errors that do not fall within the requirements above for spectacle correction may be given spectacles at investigator discretion but must follow the study-specified prescribing guidelines, as detailed below.
- •Spectacle prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months:
- •SE must be within 0.50D of fully correcting the anisometropia.
- •SE must not be under corrected by more than 1.50D SE, and reduction in plus sphere must be symmetric in the two eyes.
- •Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism.
- •Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is >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 <0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 8 weeks apart).
- •For determining VA stability (non-improvement):
- •The first of two measurements may be made 1) in current spectacles, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed),
- •The second measurement must be made without cycloplegia in the correct spectacles that have been worn for at least 8 weeks.
- •Note: since this determination is a pre-study procedure, the method of measuring VA is not mandated.
- •VA, measured in each eye without cycloplegia in current spectacle correction (if applicable) within 7 days prior to randomization using the ATS-HOTV VA protocol for children < 7 years and the E-ETDRS VA protocol for children ≥ 7 years on a study-approved device displaying single surrounded optotypes, as follows:
- •VA in the amblyopic eye 20/40 to 20/200 inclusive (ATS-HOTV) or 33 to 72 letters (E-ETDRS)
- •VA in the fellow eye 20/25 or better (ATS-HOTV) or ≥ 78 letters (E-ETDRS)
- •Interocular difference ≥ 3 logMAR lines (ATS-HOTV) or ≥ 15 letters (E-ETDRS)
- •Heterotropia with a near deviation of ≤ 5∆ (measured by SPCT) in habitual correction (Angles of ocular deviation >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)
Arms & Interventions
Binocular Computer Game Treatment
Binocular computer game treatment is defined as playing a Dig Rush application on an iPad® 1 hour per day, 5 days per week for 8 weeks in addition to continued spectacle correction (if required)
Intervention: iPad® (Other)
Continued Spectacle Correction
Continued spectacle correction is defined as wearing appropriate spectacle correction (if required) for all waking hours, 7 days per week for 8 weeks.
Intervention: Spectacle correction (Other)
Outcomes
Primary Outcomes
Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort
Time Frame: Baseline and 4 weeks
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)
Time Frame: 8 weeks
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort
Time Frame: Baseline and 8 weeks
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort
Time Frame: baseline and 4 weeks
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)
Time Frame: 8 weeks
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort
Time Frame: Baseline and 8 weeks
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Primary Outcome Measure (Older Cohort) Stratified by Sex
Time Frame: 4 Weeks
NIH-required analysis, stratified by sex. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Primary Outcome Measure (Older Cohort) Stratified by Race/Ethnicity
Time Frame: 4 Weeks
NIH-required analysis, stratified by race/ethnicity. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Primary Outcome Measure (Younger Cohort) Stratified by Sex
Time Frame: 4 Weeks
NIH-required analysis, stratified by sex. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Primary Outcome Measure (Younger Cohort) Stratified by Race/Ethnicity
Time Frame: 4 Weeks
NIH-required analysis, stratified by race/ethnicity. The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Secondary Outcomes
- VA Improvement at 4 Weeks Defined as a Binary Outcome(At 4 weeks)
- VA Improvement at 8 Weeks Defined as a Binary Outcome(At 8 weeks)
- Distribution of Stereoacuity Scores at 4 Weeks(4 weeks)
- Distribution of Change in Stereoacuity Scores From Baseline(8 weeks)
- Distribution of Stereoacuity Scores at 8 Weeks(8 weeks)
- Distribution of Stereoacuity Scores (Participants With no History of Strabismus)(8 weeks)
- Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)(8 weeks)
- Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast(8 weeks)
- Treatment Compliance With Spectacle Wear(8 weeks)
- Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort)(Baseline and 4 weeks)
- Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort)(Baseline and 8 weeks)
- Ocular Alignment at 4 Weeks(4 weeks)
- Ocular Alignment at 8 Weeks(8 weeks)
- Distribution of Diplopia Frequency at 4 Weeks (Participant-reported)(4 weeks)
- Distribution of Diplopia Frequency at 8 Weeks (Participant-reported)(8 weeks)
- Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported)(4 weeks)
- Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported)(8 weeks)
- Distribution of Diplopia Frequency at 4 Weeks (Parent-reported)(4 weeks)
- Distribution of Diplopia Frequency at 8 Weeks (Parent-reported)(8 weeks)
- Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported)(4 weeks)
- Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported)(8 weeks)
- Frequency of Adverse Symptoms (Symptom Survey)(4 weeks)
- Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks(8 weeks)
- Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks(4 weeks)
- Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks(8 weeks)
- Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort)(Baseline and 4 weeks)
- Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort)(baseline and 8 weeks)