Stereoptic serious games as a visual rehabilitation tool for individuals with a residual amblyopia (AMBER trial): a protocol for a crossover randomized controlled trial

BMC Ophthalmology

Study Protocol

Heimo Steffen¹  Gabriele Thumann¹  Martina Kropp¹  Walid Bouthour¹  Daphne Bavelier²  Dennis Levi³  Micah Murray⁴  Henning Müller⁵  Maria-Paraskevi Antoniou⁶  Cristina Simon-Martinez⁶  Pawel J. Matusz⁷  James J. Blaha⁸  Brian Dornbos⁸  Benjamin T. Backus⁸ 

[1] Department of Ophthalmology, University Hospitals of Geneva, Geneva, Switzerland;Experimental Ophthalmology, University of Geneva, Geneva, Switzerland;Faculty of Psychology and Education Sciences, University of Geneva, Geneva, Switzerland;Herbert Wertheim School of Optometry & Vision Science, Helen Wills Neuroscience Institute, University of California Berkley, Berkley, CA, USA;The Sense Innovation and Research Center, Lausanne and Sion, Sion, Switzerland;Institute of Health Sciences, School of Health Sciences, HES-SO Valais-Wallis, Sion, Switzerland;Laboratory for Investigative Neurophysiology, Department of Radiology, Lausanne University Hospital, University of Lausanne (CHUV-UNIL), Lausanne, Switzerland;University of Applied Sciences Western Switzerland (HES-SO) Valais-Wallis, Rue de Technopole 3, 3960, Sierre, Switzerland;University of Applied Sciences Western Switzerland (HES-SO) Valais-Wallis, Rue de Technopole 3, 3960, Sierre, Switzerland;Department of Ophthalmology, University Hospitals of Geneva, Geneva, Switzerland;The Sense Innovation and Research Center, Lausanne and Sion, Sion, Switzerland;Experimental Ophthalmology, University of Geneva, Geneva, Switzerland;University of Applied Sciences Western Switzerland (HES-SO) Valais-Wallis, Rue de Technopole 3, 3960, Sierre, Switzerland;Department of Ophthalmology, University Hospitals of Geneva, Geneva, Switzerland;The Sense Innovation and Research Center, Lausanne and Sion, Sion, Switzerland;Experimental Ophthalmology, University of Geneva, Geneva, Switzerland;Institute of Health Sciences, School of Health Sciences, HES-SO Valais-Wallis, Sion, Switzerland;Laboratory for Investigative Neurophysiology, Department of Radiology, Lausanne University Hospital, University of Lausanne (CHUV-UNIL), Lausanne, Switzerland;Department of Hearing & Speech Sciences, Vanderbilt University Medical Center, Nashville, TN, USA;Vivid Vision, Inc, 424 Treat Ave., Ste B, 94110, San Francisco, CA, USA;

关键词: Amblyopia;    Child;    Binocular stimulation;    Dichoptic stimulation;    Optical treatment;    Refractive correction;    Virtual reality;    Stereovision;    Visual attention;    Kinematics;    Motor control;    Electroencephalography;   

DOI  :  10.1186/s12886-023-02944-y

 received in 2023-01-18, accepted in 2023-04-25,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundAmblyopia is the most common developmental vision disorder in children. The initial treatment consists of refractive correction. When insufficient, occlusion therapy may further improve visual acuity. However, the challenges and compliance issues associated with occlusion therapy may result in treatment failure and residual amblyopia. Virtual reality (VR) games developed to improve visual function have shown positive preliminary results. The aim of this study is to determine the efficacy of these games to improve vision, attention, and motor skills in patients with residual amblyopia and identify brain-related changes. We hypothesize that a VR-based training with the suggested ingredients (3D cues and rich feedback), combined with increasing the difficulty level and the use of various games in a home-based environment is crucial for treatment efficacy of vision recovery, and may be particularly effective in children.MethodsThe AMBER study is a randomized, cross-over, controlled trial designed to assess the effect of binocular stimulation (VR-based stereoptic serious games) in individuals with residual amblyopia (n = 30, 6–35 years of age), compared to refractive correction on vision, selective attention and motor control skills. Additionally, they will be compared to a control group of age-matched healthy individuals (n = 30) to account for the unique benefit of VR-based serious games. All participants will play serious games 30 min per day, 5 days per week, for 8 weeks. The games are delivered with the Vivid Vision Home software. The amblyopic cohort will receive both treatments in a randomized order according to the type of amblyopia, while the control group will only receive the VR-based stereoscopic serious games. The primary outcome is visual acuity in the amblyopic eye. Secondary outcomes include stereoacuity, functional vision, cortical visual responses, selective attention, and motor control. The outcomes will be measured before and after each treatment with 8-week follow-up.DiscussionThe VR-based games used in this study have been conceived to deliver binocular visual stimulation tailored to the individual visual needs of the patient, which will potentially result in improved basic and functional vision skills as well as visual attention and motor control skills.Trial registrationThis protocol is registered on ClinicalTrials.gov (identifier: NCT05114252) and in the Swiss National Clinical Trials Portal (identifier: SNCTP000005024).

【 授权许可】

CC BY   
© The Author(s) 2023

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