Binocular Dig Rush Game Treatment for Amblyopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 320
- 试验地点
- 111
- 主要终点
- Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
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)
干预措施: 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.
干预措施: Spectacle correction (Other)
结局指标
主要结局
Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)