The Basic VRS-Effect Study: Clinical Trial Outcomes and Cost-Effectiveness of Low Vision Rehabilitation in Portugal

INTRODUCTION: The aim of this study was twofold: (1) to investigate the clinical impact of vision rehabilitation in patients with vision impairment and (2) to investigate the cost-effectiveness of a basic vision rehabilitation service in Portugal. METHODS: The trial recruited patients diagnosed with age-related macular degeneration or diabetic retinopathy (DR) and visual acuity in the range 0.4–1.0logMAR in the better-seeing eye. Participants were randomised to one of the study arms consisting of immediate intervention and delayed intervention. The intervention included: new refractive correction, optical reading aids, in-office training and advice about modifications at home. Visual ability, health-related quality of life and costs were measured. Economic analysis was performed to evaluate whether the intervention was cost-effective. The trial compared the outcomes 12 weeks after the start in both arms. RESULTS: Of the 46 participants, 34 (74%) were diagnosed with DR, 25 (54%) were female, and mean age was 70.08 years (SD = 8.74). In the immediate intervention arm visual ability increased a mean of 0.523 logits (SE = 0.11) (p < 0.001). Changes in the delayed intervention arm were not statistically significant (p = 0.95). Acuity in the better-seeing eye, near acuity and critical print size also improved during the study. The mean cost of the intervention was €118.79 (SD = 24.37). The incremental cost-effectiveness ratio using the EQ-5D-5L was 30,421€/QALY and 1186€/QALY when using near acuity. CONCLUSION: The current study gives evidence of positive clinical impact of a basic vision rehabilitation intervention and shows that a basic vision rehabilitation service is cost-effective. These findings are important to clinical and rehabilitation practices and for planning vision rehabilitation services. TRIAL REGISTRATION: Retrospectively registered, 21/01/2019. ISRCTN10894889, https://www.isrctn.com/ISRCTN10894889