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A randomized, clinical trial evaluating ready-made and custom spectacles delivered via a school-based screening program in China.

ABSTRACT: We sought to evaluate visual performance and satisfaction with ready-made spectacles (RMS) in Chinese school-aged children with uncorrected refractive error.Randomized, double-blind, clinical trial.Junior high school students from urban Guangzhou, China, aged approximately 12 to 15 years with > or =1 diopter (D) of uncorrected spherical equivalent (SE) refractive error. Students were excluded with > or =2.00 D astigmatism, > or =2 D myopic anisometropia, and > or =1 D hyperopic anisometropia and ocular disease affecting vision.Refractive error was determined by cycloplegic subjective refraction. Students were randomly assigned to receive RMS or custom spectacles (CS) and assessed after 1 month of use. We required 175 students to complete in each arm to be able to measure a 15% difference in compliance.Compliance with spectacles lens wear, patterns of use, vision, symptoms, and perceived value.Screening identified 965 of 4607 (20.9%) students with reduced distance vision; 212 of the 965 (22.0%) refused evaluation and 187 of the 965 (20.8%) had <1 D of SE refractive error. Sixty-one (6.3%) were referred for further evaluation and the remaining 495 (51.3%) participated. Social, demographic, and ocular parameters were similar in the 2 groups. Average SE refractive error was -2.57+/-1.31 (mean value +/- standard deviation [SD]). Spectacle vision (Snellen acuity, mean +/- SD) was worse with RMS in the eye with lower SE (20/25(-0.5)+/-0.9 lines vs 20/25(+1)+/-0.7 lines; P = 0.004) and higher SE (20/25(-2)+/-1.2 lines vs 20/25(+1)+/-0.8; P<0.001). There were no differences (P>0.05) in the rate of use (94.3% vs 92.2%), wearing to the 1-month visit (46.9% vs 51.5%), planned use (93.3% vs 93.7%), value (89.5% vs 91.7% "moderate or high value or most valued possession"), or symptoms (blur, 21.1% vs 19.4% [P = 0.8] and other symptoms [P>0.2]).Although visual acuity was better with CS, no difference was found in acceptability in this population of students with predominantly simple myopic refractive error. This study supports the use of RMS in a school-based refractive services program, saving costs and improving the logistics of service delivery.

SUBMITTER: Zeng Y

PROVIDER: S-EPMC4252048 | biostudies-literature | 2009 Oct

REPOSITORIES: biostudies-literature

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A randomized, clinical trial evaluating ready-made and custom spectacles delivered via a school-based screening program in China.

Zeng Yangfa Y Keay Lisa L He Mingguang M Mai Jingcheng J Munoz Beatriz B Brady Christopher C Friedman David S DS

Ophthalmology 20090709 10

<h4>Purpose</h4>We sought to evaluate visual performance and satisfaction with ready-made spectacles (RMS) in Chinese school-aged children with uncorrected refractive error.<h4>Design</h4>Randomized, double-blind, clinical trial.<h4>Participants</h4>Junior high school students from urban Guangzhou, China, aged approximately 12 to 15 years with > or =1 diopter (D) of uncorrected spherical equivalent (SE) refractive error. Students were excluded with > or =2.00 D astigmatism, > or =2 D myopic anis ...[more]

PMID: 19592103

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Project description: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.

Project description:Objective:Ready-made spectacles have been suggested as a less resource-intensive treatment for the millions of people living with uncorrected refractive error (URE) in low-income environments. In spite of this interest, there have been no published economic evaluations examining the cost-effectiveness of ready-made spectacles. This study aims to determine the relative cost-effectiveness of offering ready-made spectacles (RMS) relative to no intervention as well as the relative cost-effectiveness of custom-made spectacles (CS) relative to RMS to treat URE. Methods and analysis:The relative cost-effectiveness of RMS relative to CS and no intervention was tested through a cost-effectiveness analysis from the health service provider perspective conducted alongside a double-masked randomised controlled trial in an urban hospital in Delhi, India. Participants were adults aged 18-45 years with ?1?dioptre (D) of URE. Results:There was no significant difference between the effectiveness of the CS and RMS interventions in improving visual acuity, but the CS was over four times the price of the RMS per patient (204 INR (US$2.42) and 792 INR (US$11.22)). The cost per unit improvement in logarithm of the minimum angle of resolution (logMAR) relative to baseline with the RMS intervention was 407 INR (US$4.35). Existing estimates of utility resulting from improvements in visual acuity result in incremental cost per quality-adjusted life years gained of between 212 INR and 1137 INR (US$0.44-US$23.74) depending on the source of the utility estimate and assumed expected life of the spectacles. Conclusion:RMS represent a significantly cost-effective option for spectacle provision in low-resource settings. The RMS programme was substantially cheaper than an equivalent CS intervention while being effective in improving visual acuity for the majority of adults with refractive error in this setting. These findings provide further support for including RMS in programmes to address URE. Trial registration number:NCT00657670, Results.

Dataset Information

A randomized, clinical trial evaluating ready-made and custom spectacles delivered via a school-based screening program in China.

Publications

A randomized, clinical trial evaluating ready-made and custom spectacles delivered via a school-based screening program in China.

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