A randomized clinical trial to evaluate ready-made spectacles in an adult population in India

Abstract

Ready-made spectacles (RMS) have advantages; however, visual performance and satisfaction has not been evaluated. A 1-month, double-masked, randomized clinical trial comparing planned continued use and visual performance of RMS to Custom Spectacles (CS) in adults aged 18-45 years with > or =1 diopter (D) of uncorrected refractive error (URE). A total of 373 of 400 participants (93%) completed; mean age was 30 +/- 9 years, and 58% were female. Average URE was 2.21 +/- 1.31D and habitual vision was 0.58 +/- 0.21 logMAR (logarithm of Minimum Angle of Resolution, 20/63(+1) Snellen acuity). Ten participants with habitual vision better than 20/40 were excluded (3%). A lower proportion in the RMS group intended to continue to wear the study spectacles after 1 month (165/183, 90% vs 174/180, 97%, P = 0.02). Spectacle vision in the eye with lower URE was 0.08 +/- 0.15 vs 0.02 +/- 0.08, P < 0.0001 and higher URE was 0.12 +/- 0.18 vs 0.02 +/- 0.08, P < 0.0001 (logMAR) for RMS and CS. Subgroup analyses excluding participants with astigmatism > or =2.00 D and anisometropia > or =1.00 D (74/363, 20%) found no difference in planned continued use (139/143, 97% vs 141/146, 97%, P = 1.0) for RMS vs CS. While vision is slightly better with CS, 90% of an adult population with URE planned to continue to use their RMS at 1 month. Furthermore, if those without high astigmatism or anisometropia are excluded, virtually all are satisfied with RMS and there is no difference when compared with CS. 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.