A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 4 to 6 Years
Ruth E Manny, Jonathan M Holmes, Raymond T Kraker, Zhuokai Li, Amy L Waters, Krista R Kelly, Lingkun Kong, Earl R Crouch, Ingryd J Lorenzana, Maan S Alkharashi, Jennifer A Galvin, Melissa L Rice, B Michele Melia, Susan A Cotter, Pediatric Eye Disease Investigator Group, Ruth E Manny, Jonathan M Holmes, Raymond T Kraker, Zhuokai Li, Amy L Waters, Krista R Kelly, Lingkun Kong, Earl R Crouch, Ingryd J Lorenzana, Maan S Alkharashi, Jennifer A Galvin, Melissa L Rice, B Michele Melia, Susan A Cotter, Pediatric Eye Disease Investigator Group
Abstract
Significance: Binocular treatment for unilateral amblyopia is an emerging treatment that requires evaluation through a randomized clinical trial.
Purpose: This study aimed to compare change in amblyopic-eye visual acuity (VA) in children aged 4 to 6 years treated with the dichoptic binocular iPad (Apple, Cupertino, CA) game, Dig Rush (not yet commercially available; Ubisoft, Montreal, Canada), plus continued spectacle correction versus continued spectacle correction alone.
Methods: Children (mean age, 5.7 years) were randomly assigned to home treatment for 8 weeks with the iPad game (prescribed 1 h/d, 5 d/wk [n = 92], or continued spectacle correction alone [n = 90]) in a multicenter randomized clinical trial. Before enrollment, children wearing spectacles were required to have at least 16 weeks of wear or no improvement in amblyopic-eye VA (<0.1 logMAR) for at least 8 weeks. Outcome was change in amblyopic-eye VA from baseline to 4 weeks (primary) and 8 weeks (secondary) assessed by masked examiner.
Results: A total of 182 children with anisometropic (63%), strabismic (16%; <5∆ near, simultaneous prism and cover test), or combined-mechanism (20%) amblyopia (20/40 to 20/200; mean, 20/63) were enrolled. After 4 weeks, mean amblyopic VA improved by 1.1 logMAR lines with binocular treatment and 0.6 logMAR lines with spectacles alone (adjusted difference, 0.5 lines; 95.1% confidence interval [CI], 0.1 to 0.9). After 8 weeks, results (binocular treatment: mean amblyopic-eye VA improvement, 1.3 vs. 1.0 logMAR lines with spectacles alone; adjusted difference, 0.3 lines; 98.4% CI, -0.2 to 0.8 lines) were inconclusive because the CI included both zero and the pre-defined difference in mean VA change of 0.75 logMAR lines.
Conclusions: In 4- to 6-year-old children with amblyopia, binocular Dig Rush treatment resulted in greater improvement in amblyopic-eye VA for 4 weeks but not 8 weeks. Future work is required to determine if modifications to the contrast increment algorithm or other aspects of the game or its implementation could enhance the treatment effect.
Trial registration: ClinicalTrials.gov NCT02983552.
Conflict of interest statement
Conflict of Interest Disclosure: None of the authors have reported a financial conflict of interest.
Copyright © 2022 American Academy of Optometry.
Figures
![Appendix Figure A1,](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8919092/bin/nihms-1771745-f0006.jpg)
![Figure 1.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8919092/bin/nihms-1771745-f0001.jpg)
Figure 2.
Figure 2.
Figure 3.
Treatment group difference in the…
Figure 3.
Treatment group difference in the mean change in amblyopic-eye visual acuity from baseline…
Figure 4.
Relationships of hours played and…
Figure 4.
Relationships of hours played and contrast settings (from the log file) with treatment…
Figure 5.
Relationships of hours played and…
Figure 5.
Relationships of hours played and contrast settings (from the log file) with treatment…
- A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years.Pediatric Eye Disease Investigator Group; Holmes JM, Manny RE, Lazar EL, Birch EE, Kelly KR, Summers AI, Martinson SR, Raghuram A, Colburn JD, Law C, Marsh JD, Bitner DP, Kraker RT, Wallace DK. Pediatric Eye Disease Investigator Group, et al. Ophthalmology. 2019 Mar;126(3):456-466. doi: 10.1016/j.ophtha.2018.10.032. Epub 2018 Oct 22. Ophthalmology. 2019. PMID: 30352226 Free PMC article. Clinical Trial.
- Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With Amblyopia: A Randomized Clinical Trial.Holmes JM, Manh VM, Lazar EL, Beck RW, Birch EE, Kraker RT, Crouch ER, Erzurum SA, Khuddus N, Summers AI, Wallace DK; Pediatric Eye Disease Investigator Group. Holmes JM, et al. JAMA Ophthalmol. 2016 Dec 1;134(12):1391-1400. doi: 10.1001/jamaophthalmol.2016.4262. JAMA Ophthalmol. 2016. PMID: 27812703 Free PMC article. Clinical Trial.
- Binocular iPad Game vs Patching for Treatment of Amblyopia in Children: A Randomized Clinical Trial.Kelly KR, Jost RM, Dao L, Beauchamp CL, Leffler JN, Birch EE. Kelly KR, et al. JAMA Ophthalmol. 2016 Dec 1;134(12):1402-1408. doi: 10.1001/jamaophthalmol.2016.4224. JAMA Ophthalmol. 2016. PMID: 27832248 Free PMC article. Clinical Trial.
- Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years.Tailor V, Ludden S, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Tailor V, et al. Cochrane Database Syst Rev. 2022 Feb 7;2(2):CD011347. doi: 10.1002/14651858.CD011347.pub3. Cochrane Database Syst Rev. 2022. PMID: 35129211 Free PMC article. Review.
- Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years.Tailor V, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Tailor V, et al. Cochrane Database Syst Rev. 2015 Aug 11;2015(8):CD011347. doi: 10.1002/14651858.CD011347.pub2. Cochrane Database Syst Rev. 2015. PMID: 26263202 Free PMC article. Updated. Review.
- Risk of recurrence after cessation of dichoptic, binocular treatment of amblyopia.Jost RM, Kelly KR, Birch EE. Jost RM, et al. J AAPOS. 2023 Oct;27(5):298-300. doi: 10.1016/j.jaapos.2023.06.009. Epub 2023 Aug 23. J AAPOS. 2023. PMID: 37619861
- Amblyopia and the whole child.Birch EE, Kelly KR. Birch EE, et al. Prog Retin Eye Res. 2023 Mar;93:101168. doi: 10.1016/j.preteyeres.2023.101168. Epub 2023 Feb 1. Prog Retin Eye Res. 2023. PMID: 36736071 Review.
- Evaluation of the Efficacy of a New Dichoptic Digital Platform to Treat the Anisometropic and Isometropic Amblyopia.Abdal MO, Bhombal F, Nankani GJ, Nankani SG, Lad S, Dholam A, Kumari R, Mahajan J, Piñero DP. Abdal MO, et al. Brain Sci. 2022 Jun 22;12(7):815. doi: 10.3390/brainsci12070815. Brain Sci. 2022. PMID: 35884623 Free PMC article.
- Long-Term Efficacy of the Combination of Active Vision Therapy and Occlusion in Children with Strabismic and Anisometropic Amblyopia.Milla M, Molina-Martín A, Piñero DP. Milla M, et al. Children (Basel). 2022 Jul 7;9(7):1012. doi: 10.3390/children9071012. Children (Basel). 2022. PMID: 35883996 Free PMC article.
-
- Papageorgiou E, Asproudis I, Maconachie G, et al. The Treatment of Amblyopia: Current Practice and Emerging Trends. Graefes Arch Clin Exp Ophthalmol 2019;257:1061–78. - PubMed
-
- Stewart CE, Moseley MJ, Stephens DA, et al. Treatment Dose-Response in Amblyopia Therapy: The Monitored Occlusion Treatment of Amblyopia Study (MOTAS). Invest Ophthalmol Vis Sci 2004;45:3048–54. - PubMed
-
- Awan M, Proudlock FA, Gottlob I. A Randomized Controlled Trial of Unilateral Strabismic and Mixed Amblyopia Using Occlusion Dose Monitors to Record Compliance. Invest Ophthalmol Vis Sci 2005;46:1435–9. - PubMed
-
- Hiscox F, Strong N, Thompson JR, et al. Occlusion for Amblyopia: A Comprehensive Survey of Outcome. Eye 1992;6:300–4. - PubMed
- Multicenter Study
- Randomized Controlled Trial
- Research Support, N.I.H., Extramural
- Amblyopia* / therapy
- Child
- Child, Preschool
- Eyeglasses
- Follow-Up Studies
- Humans
- Sensory Deprivation
- Treatment Outcome
- Vision, Binocular
- ClinicalTrials.gov/NCT02983552
- Full Text Sources
- Medical
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![Figure 2.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8919092/bin/nihms-1771745-f0002.jpg)
![Figure 3.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8919092/bin/nihms-1771745-f0003.jpg)
![Figure 4.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8919092/bin/nihms-1771745-f0004.jpg)
Figure 5.
Relationships of hours played and…
Figure 5.
Relationships of hours played and contrast settings (from the log file) with treatment…
- A Randomized Trial of Binocular Dig Rush Game Treatment for Amblyopia in Children Aged 7 to 12 Years.Pediatric Eye Disease Investigator Group; Holmes JM, Manny RE, Lazar EL, Birch EE, Kelly KR, Summers AI, Martinson SR, Raghuram A, Colburn JD, Law C, Marsh JD, Bitner DP, Kraker RT, Wallace DK. Pediatric Eye Disease Investigator Group, et al. Ophthalmology. 2019 Mar;126(3):456-466. doi: 10.1016/j.ophtha.2018.10.032. Epub 2018 Oct 22. Ophthalmology. 2019. PMID: 30352226 Free PMC article. Clinical Trial.
- Effect of a Binocular iPad Game vs Part-time Patching in Children Aged 5 to 12 Years With Amblyopia: A Randomized Clinical Trial.Holmes JM, Manh VM, Lazar EL, Beck RW, Birch EE, Kraker RT, Crouch ER, Erzurum SA, Khuddus N, Summers AI, Wallace DK; Pediatric Eye Disease Investigator Group. Holmes JM, et al. JAMA Ophthalmol. 2016 Dec 1;134(12):1391-1400. doi: 10.1001/jamaophthalmol.2016.4262. JAMA Ophthalmol. 2016. PMID: 27812703 Free PMC article. Clinical Trial.
- Binocular iPad Game vs Patching for Treatment of Amblyopia in Children: A Randomized Clinical Trial.Kelly KR, Jost RM, Dao L, Beauchamp CL, Leffler JN, Birch EE. Kelly KR, et al. JAMA Ophthalmol. 2016 Dec 1;134(12):1402-1408. doi: 10.1001/jamaophthalmol.2016.4224. JAMA Ophthalmol. 2016. PMID: 27832248 Free PMC article. Clinical Trial.
- Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years.Tailor V, Ludden S, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Tailor V, et al. Cochrane Database Syst Rev. 2022 Feb 7;2(2):CD011347. doi: 10.1002/14651858.CD011347.pub3. Cochrane Database Syst Rev. 2022. PMID: 35129211 Free PMC article. Review.
- Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years.Tailor V, Bossi M, Bunce C, Greenwood JA, Dahlmann-Noor A. Tailor V, et al. Cochrane Database Syst Rev. 2015 Aug 11;2015(8):CD011347. doi: 10.1002/14651858.CD011347.pub2. Cochrane Database Syst Rev. 2015. PMID: 26263202 Free PMC article. Updated. Review.
- Risk of recurrence after cessation of dichoptic, binocular treatment of amblyopia.Jost RM, Kelly KR, Birch EE. Jost RM, et al. J AAPOS. 2023 Oct;27(5):298-300. doi: 10.1016/j.jaapos.2023.06.009. Epub 2023 Aug 23. J AAPOS. 2023. PMID: 37619861
- Amblyopia and the whole child.Birch EE, Kelly KR. Birch EE, et al. Prog Retin Eye Res. 2023 Mar;93:101168. doi: 10.1016/j.preteyeres.2023.101168. Epub 2023 Feb 1. Prog Retin Eye Res. 2023. PMID: 36736071 Review.
- Evaluation of the Efficacy of a New Dichoptic Digital Platform to Treat the Anisometropic and Isometropic Amblyopia.Abdal MO, Bhombal F, Nankani GJ, Nankani SG, Lad S, Dholam A, Kumari R, Mahajan J, Piñero DP. Abdal MO, et al. Brain Sci. 2022 Jun 22;12(7):815. doi: 10.3390/brainsci12070815. Brain Sci. 2022. PMID: 35884623 Free PMC article.
- Long-Term Efficacy of the Combination of Active Vision Therapy and Occlusion in Children with Strabismic and Anisometropic Amblyopia.Milla M, Molina-Martín A, Piñero DP. Milla M, et al. Children (Basel). 2022 Jul 7;9(7):1012. doi: 10.3390/children9071012. Children (Basel). 2022. PMID: 35883996 Free PMC article.
-
- Papageorgiou E, Asproudis I, Maconachie G, et al. The Treatment of Amblyopia: Current Practice and Emerging Trends. Graefes Arch Clin Exp Ophthalmol 2019;257:1061–78. - PubMed
-
- Stewart CE, Moseley MJ, Stephens DA, et al. Treatment Dose-Response in Amblyopia Therapy: The Monitored Occlusion Treatment of Amblyopia Study (MOTAS). Invest Ophthalmol Vis Sci 2004;45:3048–54. - PubMed
-
- Awan M, Proudlock FA, Gottlob I. A Randomized Controlled Trial of Unilateral Strabismic and Mixed Amblyopia Using Occlusion Dose Monitors to Record Compliance. Invest Ophthalmol Vis Sci 2005;46:1435–9. - PubMed
-
- Hiscox F, Strong N, Thompson JR, et al. Occlusion for Amblyopia: A Comprehensive Survey of Outcome. Eye 1992;6:300–4. - PubMed
- Multicenter Study
- Randomized Controlled Trial
- Research Support, N.I.H., Extramural
- Amblyopia* / therapy
- Child
- Child, Preschool
- Eyeglasses
- Follow-Up Studies
- Humans
- Sensory Deprivation
- Treatment Outcome
- Vision, Binocular
- ClinicalTrials.gov/NCT02983552
- Full Text Sources
- Medical
![Figure 5.](https://www.ncbi.nlm.nih.gov/pmc/articles/instance/8919092/bin/nihms-1771745-f0005.jpg)
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Source: PubMed