Spectacle wearing in children randomised to ready-made or custom spectacles, and potential cost savings to programmes: study protocol for a randomised controlled trial

Abstract

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

Predictors of Spectacle Wear and Reasons for Nonwear in Students Randomized to Ready-made or Custom-made Spectacles

“…16,24,30,31 The results presented in this article reflect the planned secondary objectives of a noninferiority randomized clinical trial undertaken in Bangalore, India, the goal of which was to compare spectacle wear in school students randomized to readymade or custom-made spectacles. 32 Spectacle wear in both trial arms was similar, including 139 of 184 students (75.5%) in the ready-made arm and 131 of 178 students (73.6%) in the custommade arm (risk difference, 1.8%; 95% CI, −7.1% to 10.8%). 33 Herein, we report reasons for nonwear and predictors of wear among students recruited to this trial.…”

Refractive error in underserved adults

“…(42–44) Ready-made spectacles (RMS) with on-site edging equipment are a low-cost alternative that can enable RMS to be dispensed immediately, if custom-made spectacles are not financially feasible. (45) In a prospective double-masked randomized trial with 363 adults aged between 18 and 45 years with ≥ 1 diopter of URE, RMS produced large improvements in their QoL and a similar degree of satisfaction with vision at the 1-month follow-ups. (46, 47)…”

Effectiveness of a novel mobile health education intervention (Peek) on spectacle wear among children in India: study protocol for a randomized controlled trial

“…In this study, children could select the spectacle frames they preferred and almost 75% were wearing their spectacles at unannounced visits 3–4 months later [20]. …”