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

Article Article scientifique Article Stereoptic serious games as a visual rehabilitation tool for individuals with a residual amblyopia (AMBER trial): a protocol for a crossover randomized controlled trial eng 2023-05-17 2023-05-17 author Simon Martinez Cristina 402692 author Antoniou Maria-Paraskevi 917331 author Bouthour Walid 866118 author Bavelier Daphné 737548 Section de psychologie (PSICO) author Levi Dennis author Backus Benjamin T. author Dornbos Brian author Blaha James J. author Kropp Martina 0000-0001-6861-5851 793095 author Muller Henning 126188 Département de radiologie et informatique médicale (RADIO) author Murray Micah 134299 author Thumann Gabriele 0000-0003-3682-9569 785873 Département des neurosciences cliniques (OTONO) author Steffen Heimo 844244 Département des neurosciences cliniques (OTONO) author Matusz Pawel 989513 220 10.1186/s12886-023-02944-y 37198558 1471-2415 PMC10190050 https://bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-023-02944-y Background: Amblyopia 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. Methods: The 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. Discussion: The 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 registration: This protocol is registered on ClinicalTrials.gov (identifier: <a href="http://clinicaltrials.gov/show/NCT05114252" rel="noopener noreferrer" target="_blank">NCT05114252</a>) and in the Swiss National Clinical Trials Portal (identifier: SNCTP000005024). Amblyopia Binocular stimulation Child Dichoptic stimulation Electroencephalography Kinematics Motor control Optical treatment Refractive correction Stereovision Virtual reality Visual attention Dewey 616.8 Dewey 150 108 Section de psychologie 71 61 Département des neurosciences cliniques 226 false 1373 Brain & Learning Lab 582 Ophtalmologie expérimentale 925 BMC ophthalmology 23 1 f35219f8-9ceb-486d-8c35-ec468a3be475 Article (Published version) Public Article-scientifique-from-crossref.pdf 2702912 application/pdf CC BY-4.0 a23a964b6ba6705ac279e22f1f419a8a0bfe29220b824ceef81f5357020b0e29 openAccess Faculté de psychologie et des sciences de l'éducation / Section de psychologie Faculté de médecine / Section de médecine clinique / Département des neurosciences cliniques

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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			2023	135	44

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Simon Martinez, Cristina