RT info:eu-repo/semantics/doctoralThesis T1 Diseño, desarrollo y evaluación de un nuevo sistema basado en Realidad Virtual para el tratamiento de la ambliopía A1 Leal Vega, Luis A2 Universidad de Valladolid. Escuela de Doctorado K1 Optometría - ambliopía K1 Amblyopia K1 Ambliopía K1 Virtual reality K1 Realidad virtual K1 Perceptual learning K1 Aprendizaje perceptivo K1 Dichoptic training K1 Entrenamiento dicóptico K1 32 Ciencias Médicas AB Introduction:Amblyopia is defined as a neurodevelopmental disorder of the visual system that results in a decrease in best-corrected visual acuity (BCVA) of one, or less frequently, both eyes, in the absence of an organic cause. In recent years, there has been a growing interest in the development of alternative methods for the treatment of amblyopia, as conventional occlusion therapy has a low adherence rate and is not effective in a significant proportion of patients. The aim of this doctoral thesis is to evaluate the efficacy and safety of a new virtual reality (VR)-based visual training system as an alternative to occlusion therapy in amblyopic patients with non-compliance or non-response to patching.Material and methods:The NEIVATECH system has been designed as a serious game (SG) for the provision of binocular training to amblyopic patients by combining the concepts of perceptual learning and dichoptic training in an interactive and immersive VR environment. In a first experiment, the effects of 20 minutes of exposure to the system on the visual function of a sample of healthy adult individuals (3 men, 7 women, 31.80 ± 6.49 years) were evaluated and its safety and acceptability profile were determined. Subsequently, a second experiment was conducted in which 12 amblyopic children (6 boys, 6 girls, 11.25 ± 2.45 years) with non-compliance or non-response to conventional occlusion therapy were recruited for a total of 9 hours of therapy with the system in 18 sessions of 30 minutes each, spread over 1 month. As primary outcome measure, the effects of the therapy on patients' visual function were evaluated, and as secondary outcome measures, the safety and usability of the system, as well as patient satisfaction with the therapy were evaluated. All the experiments were approved by the Drug Research Ethics Committee (CEIm) of the Valladolid East Health Care Area (Ref.: CASVE-NM-21-516). Statistical significance was set at a p-value < 0.05 and analyses were performed with the statistical package R 4.3.2.Results:In the experiment I, the NEIVATECH system showed an adequate safety and acceptability profile in healthy adult individuals. Exposure to the system only resulted in statistically significant visual differences in the distance Cover Test (CT) (p = 0.016), but these were not clinically relevant. After therapy with the NEIVATECH system, statistically significant changes were observed in the near BCVA of the amblyopic eye (p = 0.022) and the dominant eye (p = 0.022), the break (p = 0.012) and recovery (p = 0.009) points of the negative fusional vergence (NFV) for distance vision, and the scores obtained in the TNO stereo test after applying the Binocular Function Score factor to account for those cases with complete suppression and no measurable stereopsis (p = 0.045). The safety and usability of the system and patient satisfaction with the therapy also proved to be adequate.Conclusion:The NEIVATECH system demonstrated efficacy and was well tolerated by amblyopic patients with non-compliance or non-response to patching, making it a treatment option to be validated in future studies. Among others, it could be investigated which training regimen is most suitable for these patients, or whether the administration of the therapy alone or in combination with other treatments could provide a greater improvement in visual function compared to a control group. YR 2024 FD 2024 LK https://uvadoc.uva.es/handle/10324/71389 UL https://uvadoc.uva.es/handle/10324/71389 LA spa NO Escuela de Doctorado DS UVaDOC RD 22-nov-2024