TY - JOUR
T1 - A randomized clinical trial to evaluate ready-made spectacles in an adult population in India
AU - Keay, Lisa
AU - Gandhi, Monica
AU - Brady, Christopher
AU - Ali, Ferhina S.
AU - Mathur, Umang
AU - Munoz, Beatriz
AU - Friedman, David S.
N1 - Funding Information:
The strengths of this study lie in the approach, low rate of loss to follow-up (7%) and minimal cross-over. All errors in spectacle orders were detected by comparing the measurements with the prescription and were low (2%). The treatment was randomly assigned and the similarity in demographic and socio-economic characteristics of the two groups indicates that randomization was successful. The masking of the participant and those involved in data collection reduced the likelihood of bias in subjective responses and lends further credibility to the study findings; although we acknowledge that the success of masking was not independently assessed. The rate of planned continued use was supported by differences observed in subjective impressions, WTP and rate of symptoms. Differences in performance were influenced by the
PY - 2010/2/9
Y1 - 2010/2/9
N2 - Background Ready-made spectacles (RMS) have advantages; however, visual performance and satisfaction has not been evaluated. Methods 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 ≥ diopter (D) of uncorrected refractive error (URE). Results 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 ≥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. Conclusions 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.
AB - Background Ready-made spectacles (RMS) have advantages; however, visual performance and satisfaction has not been evaluated. Methods 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 ≥ diopter (D) of uncorrected refractive error (URE). Results 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 ≥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. Conclusions 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.
KW - Public health
KW - Randomized clinical trial
KW - Ready-made spectacles
KW - Refractive services
KW - Uncorrected refractive error
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U2 - 10.1093/ije/dyp384
DO - 10.1093/ije/dyp384
M3 - Article
C2 - 20147300
AN - SCOPUS:77955757231
SN - 0300-5771
VL - 39
SP - 877
EP - 888
JO - International journal of epidemiology
JF - International journal of epidemiology
IS - 3
M1 - dyp384
ER -