Priya Morjaria1, Jenifer Evans1, Kaushik Murali2, Clare Gilbert1. 1. Faculty of Infectious Tropical Diseases, Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, United Kingdom. 2. Sankara Eye Hospital, Bengaluru, India.
Abstract
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. Trial Registration: isrctn.com Identifier: ISRCTN14715120.
RCT Entities:
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. Trial Registration: isrctn.com Identifier: ISRCTN14715120.
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