Abstract
Purpose: :
To compare the visual performance and acceptability of ready-made spectacles (RMS) and custom spectacles (CS) in adults with uncorrected refractive error in India.
Methods: :
A 1-month, double-masked randomized clinical trial compared RMS to CS in adults aged 18-45 years with ≥1 diopter (D) of uncorrected refractive error (URE). The primary outcome was the proportion planning to continue to use the study spectacles.
Results: :
373 of 400 participants (93%) were enrolled and completed the study; mean age was 30±9 years and 58% were female. Average URE was 2.27±1.37D, 279/390 (72%) were myopic and habitual vision was 0.58±0.21 (logMAR). 10 participants with habitual vision better than 20/40 were excluded from the analysis (3%). The two groups were similar comparing age, sex, income, education level and overall health, with 193 randomized to RMS and 197 to CS. A lower proportion in the RMS group intended to continue to wear the study spectacles after 1-month (265/183, 90% vs 174/180, 97%, p=0.02). Spectacle vision in the eye with lower URE was 0.07±0.14 vs 0.01±0.08, p<0.0001 and higher URE was 0.11±0.18 vs 0.02±0.08, p<0.0001 (logMAR) for RMS and CS respectively. Subgroup analyses excluding participants with astigmatism ≥2.00D and anisometropia ≥1.00D (74/363, 20%) found no difference in planned continued use (139/143, 97% vs 141/146, 97%, p=1.0) for RMS vs CS respectively.
Conclusions: :
While we found CS provides slightly better vision than RMS, we found that 90% of an adult population with URE planned to continue to use their RMS. Furthermore, if RMS are provided to those without high astigmatism or anisometropia, virtually all are satisfied with RMS. The findings of this study support the use of RMS for the delivery of refractive services in settings where there is a high level of need, limited resources and low access to refractive services.
Clinical Trial: :
www.clinicaltrials.gov NCT00657670
Keywords: refraction • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • quality of life