Abstract
PurposeTo study, for the first time, the effect of wearing ready-made glasses and glasses with power determined by self-refraction on children's quality of life.
MethodsThis is a randomized, double-masked non-inferiority trial. Children in grades 7 and 8 (age 12-15years) in nine Chinese secondary schools, with presenting visual acuity (VA) 6/12 improved with refraction to 6/7.5 bilaterally, refractive error -1.0 D and <2.0 D of anisometropia and astigmatism bilaterally, were randomized to receive ready-made spectacles (RM) or identical-appearing spectacles with power determined by: subjective cycloplegic retinoscopy by a university optometrist (U), a rural refractionist (R) or non-cycloplegic self-refraction (SR). Main study outcome was global score on the National Eye Institute Refractive Error Quality of Life-42 (NEI-RQL-42) after 2months of wearing study glasses, comparing other groups with the U group, adjusting for baseline score.
ResultsOnly one child (0.18%) was excluded for anisometropia or astigmatism. A total of 426 eligible subjects (mean age 14.2years, 84.5% without glasses at baseline) were allocated to U [103 (24.2%)], RM [113 (26.5%)], R [108 (25.4%)] and SR [102 (23.9%)] groups, respectively. Baseline and endline score data were available for 398 (93.4%) of subjects. In multiple regression models adjusting for baseline score, older age (p=0.003) and baseline spectacle wear (p=0.016), but not study group assignment, were significantly associated with lower final score.
ConclusionQuality of life wearing ready-mades or glasses based on self-refraction did not differ from that with cycloplegic refraction by an experienced optometrist in this non-inferiority trial