Results of the basic-VRS trial: clinical outcomes and cost-effectiveness of basic low vision rehabilitation in Portugal

Purpose The aim of this study was twofold: i) to investigate and characterize the clinical impact of vision rehabilitation in patients with vision impairment, and ii) to investigate the cost-effectiveness of a basic vision rehabilitation service in Portugal. Methods Patients diagnosed with age-related macular degeneration or diabetic retinopathy and visual acuity in the range 0.4 to 1.0 logMAR in the better-seeing eye were recruited. 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 of the intervention were measured. Economic analysis was performed to evaluated if 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 diabetic retinopathy, 25(54%) were female and the mean age was 70.08 yrs (SD=8.74). In the immediate intervention arm visual ability was 0.28 logits (SD=1.14) at baseline and it increased to 0.91logits (SD=1.24) after the intervention (p<0.001). Changes in the delayed intervention arm were not statistically significant (mean improvement = 0.10 logits, SE=0.11, 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). Incremental cost-effectiveness ratio using the EQ-5D-5L index value was €3322/QALY and €1235/QALY when using near acuity. Conclusions The current study gives evidence of positive clinical impact of a basic vision rehabilitation intervention and that a basic vision rehabilitation service is cost-effective. These findings are important to clinical and rehabilitation practices and for planning vision rehabilitation services. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN10894889 ### Clinical Protocols ### Funding Statement Ophthalmic lenses and part of the magnifiers were supported by Essilor Portugal and FCT Strategic Funding UID/FIS/04650/2013. AFM was funded by the faculty of Health and Life Sciences at Linnaeus University ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Ethics Committee for Life Sciences and Health of the University of Minho (SECVS 147/2016), and by the Hospital Santa Maria Maior's ethics committee. Portuguese data protection authority approval number: 7012/ 2017. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors