Accepted for/Published in: JMIR Serious Games
Date Submitted: Jun 18, 2024
Date Accepted: Nov 8, 2024
Transformative Gamified Binocular Therapy for Unilateral Amblyopia in Young Children: Efficacy and Safety in a Prospective Pilot Study
ABSTRACT
Background:
Amblyopia is a common cause of visual impairment in children. The compliance with traditional treatments of amblyopia is challenging due to negative psychosocial impacts. Recent shifts in amblyopia treatment have moved from suppressing the dominant eye to enhancing binocular visual function. Binocular digital therapy has become a promising approach.
Objective:
The aim of this paper was to evaluate the effects of binocular gamified digital therapy on visual acuity and stereoacuity (SA) in children with unilateral amblyopia.
Methods:
This pilot prospective study enrolled eleven children aged 4 to 6 years with unilateral amblyopia. Following at least eight weeks of refractive correction, participants underwent binocular gamified digital therapy for 60 minutes per day, five days a week. The therapy utilized a Roguelike shooting game delivered under binocular conditions through two independent channels with a real-time artificial intelligence visual engine. Assessments of distance visual acuity (DVA), near visual acuity (NVA), SA, and visual perception were conducted at baseline, and again at 4, 8, and 12 weeks. Visual perception was evaluated using the Developmental Test of Visual Perception 3 (DTVP), which assesses visual-motor integration, motor-reduced visual perception, and general visual perception.
Results:
At 12 weeks, significant improvements were noted: amblyopic-eye DVA improved by 1.0 lines (95% CI: 0.3-2.1 lines), binocular DVA by 0.7 lines (95% CI: 0.2-0.9 lines), and SA by 0.3 log-arseconds (95% CI: 0.09-0.51). At 8 weeks, improvements included amblyopic-eye DVA by 0.9 lines (95% CI: 0-1.3 lines) and SA by 0.28 log-arseconds (95% CI: 0.06-0.48). Additionally, there were notable increases in DTVP scores, specifically in the visual-motor integration domain score (p = 0.043) and the general visual perception domain score (p = 0.031). No significant adverse events were observed, although one participant developed progressive esotropia.
Conclusions:
Binocular gamified digital therapy is effective and safe for improving visual outcomes in children aged 4 to 6 years with unilateral amblyopia. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2300072066. Registered 1 June 2023, https://www.chictr.org.cn/showproj.html?proj=198625
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.