Central vision loss (CVL) is a major form of low vision that remains inadequately managed worldwide. This study evaluated the clinical efficacy of a novel head-mounted device (HMD), Onyx, designed to enhance visual function and vision-related quality of life for CVL patients. It employs a projection system that enables patients to leverage their residual peripheral vision for environmental awareness. It also integrates artificial intelligence to augment the automatic recognition of text, faces, and objects. In this single-center, prospective cohort study, 41 binocularly low vision patients with CVL were instructed to use Onyx for 4 to 6 h daily over a one-month period. Various metrics were assessed, including near and distance visual acuity (VA), recognition abilities for faces and objects, and the low vision quality-of-life (LVQOL) questionnaire scores, at the start and end of the study. The results showed significant improvements in near VA for 60.98% of the participants, distance VA for 80.49%, and recognition ability for 90.24%. 68.29% of the participants showed significant improvements in the LVQOL scores. Improvement in recognition ability was negatively correlated with baseline recognition ability. Additionally, improvement in the LVQOL scores was correlated with age and the baseline LVQOL score. Overall, the study found that the novel HMD significantly improved visual function and vision-related quality of life for low vision patients with CVL, highlighting the potential benefits and the need for further evaluation of such devices.
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