IMPORTANCE Uncorrected refractive errors are the most common cause of visual impairment in children despite correction being highly cost-effective. OBJECTIVE To determine whether less expensive ready-made spectacles produce rates of spectacle wear at 3 to 4 months comparable to those of more expensive custom-made spectacles among eligible school-aged children. DESIGN, SETTING, AND PARTICIPANTS This noninferiority, double-masked, randomized clinical trial recruited children aged 11 to 15 years from January 12 through July 31, 2015, from government schools in urban and periurban areas surrounding Bangalore, India. Follow-up occurred from August 1 through September 31, 2015. Participants met the following eligibility criteria for ready-made spectacles: failed vision screening at the 6/9 level in each eye; refraction was indicated; acuity improved with correction by 2 or more lines in the better-seeing eye; the corrected acuity with the spherical equivalent was not more than 1 line less than with full correction; anisometropia measured less than 1.0 diopter; and an appropriate frame was available. INTERVENTIONS Eligible children were randomized to ready-made or custom-made spectacles. MAIN OUTCOMES AND MEASURES Proportion of children wearing their spectacles at unannounced visits 3 to 4 months after the intervention. RESULTS Of 23 345 children aged 11 to 15 years who underwent screening, 694 had visual acuity of less than 6/9 in both eyes, and 535 underwent assessment for eligibility. A total of 460 children (227 female [49.3%] and 233 male [50.7%]; mean [SD] age, 13.4 [1.3] years) were eligible for ready-made spectacles (2.0% undergoing screening and 86.0% undergoing assessment) and were randomized to ready-made (n = 232) or custom-made (n = 228) spectacles. Follow-up rates at 3 to 4 months were similar (184 [79.3%] in the ready-made group and 178 [78.1%] in the custom-made group). Rates of spectacle wear in the 2 arms were similar among 139 of 184 children (75.5%) in the ready-made arm and 131 of 178 children (73.6%) in the custom-made arm (risk difference, 1.8%; 95% CI, −7.1% to 10.8%). CONCLUSIONS AND RELEVANCE Most children were eligible for ready-made spectacles, and the proportion wearing ready-made spectacles was not inferior to the proportion wearing custom-made spectacles at 3 to 4 months. These findings suggest that ready-made spectacles could substantially reduce costs for school-based eye health programs in India without compromising spectacle wear, at least in the short term.
BackgroundUncorrected refractive errors are the commonest cause of visual impairment in children, with myopia being the most frequent type. Myopia usually starts around 9 years of age and progresses throughout adolescence. Hyperopia usually affects younger children, and astigmatism affects all age groups. Many children have a combination of myopia and astigmatism. To correct refractive errors, the type and degree of refractive error are measured and appropriate corrective lenses prescribed and dispensed in the spectacle frame of choice. Custom spectacles (that is, with the correction specifically required for that individual) are required if astigmatism is present, and/or the refractive error differs between eyes. Spectacles without astigmatic correction and where the refractive error is the same in both eyes are straightforward to dispense. These are known as ’ready-made’ spectacles. High-quality spectacles of this type can be produced in high volume at an extremely low cost. Although spectacle correction improves visual function, a high proportion of children do not wear their spectacles for a variety of reasons. The aim of this study is to compare spectacle wear at 3–4 months amongst school children aged 11 to 15 years who have significant, simple uncorrected refractive error randomised to ready-made or custom spectacles of equivalent quality, and to evaluate cost savings to programmes. The study will take place in urban and semi-urban government schools in Bangalore, India. The hypothesis is that similar proportions of children randomised to ready-made or custom spectacles will be wearing their spectacles at 3–4 months.Methods/designThe trial is a randomised, non-inferiority, double masked clinical trial of children with simple uncorrected refractive errors. After screening, children will be randomised to ready-made or custom spectacles. Children will choose their preferred frame design. After 3–4 months the children will be followed up to assess spectacle wear.DiscussionReady-made spectacles have benefits for providers as well as parents and children, as a wide range of prescriptions and frame types can be taken to schools and dispensed immediately. In contrast, custom spectacles have to be individually made up in optical laboratories, and taken back to the school and given to the correct child.Trial registrationISRCTN14715120 (Controlled-Trials.com)Date registered: 04 February 2015
PurposeTo compare and validate the accuracy and ease of use of handheld autorefractors against retinoscopic refraction by an ophthalmologist for assessing the visual acuity of older adults in India.Methods190 patients were enrolled at the Sankara Eye Hospital in Bangalore, India, to undergo refraction using three different handheld devices—Retinomax (Nikon Inc., Japan), Netra (Eyenetra, Inc., USA), and QuickSee (PlenOptika, Inc., USA)—and the results were compared with cycloplegic retinoscopy and refraction done by an ophthalmologist. We analyzed the mean, standard deviation (S.D.), and Bland-Altman comparison of dioptric (D) power accuracy.ResultsThe difference between the handheld devices and subjective refraction for each device was: Retinomax (N = 186), mean -0.41 D, S.D. 2.14; Netra (N = 179), mean 0.61 D, S.D. 2.20; and QuickSee (N = 182), mean -0.05 D, S.D. 1.04.ConclusionThe QuickSee and the Retinomax may be used successfully as refraction screening tools in epidemiologic studies of adults in India and as diagnostic tools in low-resource settings.
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