Elsevier

Ophthalmology

Volume 116, Issue 10, October 2009, Pages 1839-1845
Ophthalmology

Original article
A Randomized, Clinical Trial Evaluating Ready-Made and Custom Spectacles Delivered Via a School-Based Screening Program in China

https://doi.org/10.1016/j.ophtha.2009.04.004Get rights and content

Purpose

We sought to evaluate visual performance and satisfaction with ready-made spectacles (RMS) in Chinese school-aged children with uncorrected refractive error.

Design

Randomized, double-blind, clinical trial.

Participants

Junior high school students from urban Guangzhou, China, aged approximately 12 to 15 years with ≥1 diopter (D) of uncorrected spherical equivalent (SE) refractive error. Students were excluded with ≥2.00 D astigmatism, ≥2 D myopic anisometropia, and ≥1 D hyperopic anisometropia and ocular disease affecting vision.

Methods

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.

Main Outcome Measures

Compliance with spectacles lens wear, patterns of use, vision, symptoms, and perceived value.

Results

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]).

Conclusions

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.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found after the references.

Section snippets

Methods

At the time of the study, a school-based vision screening and spectacle delivery program (ChildSight, Helen Keller International) was in place in urban Guangzhou, China. The current study was attached to this screening program. The Johns Hopkins Medicine Institutional Review Board and the Zhongshan Ophthalmic Center Institutional Review Board approved the study protocol and this clinical trial was registered with the US National Institutes of Health Protocol Registration System (available at: //register.clinicaltrials.gov

Results

The school screening program evaluated 88% of the 5211 students enrolled in junior high school in the 5 target schools (Fig 1). Of the 965 identified as possible candidates through this process, 743 (77%) were interested in participating. Enrollment visits were conducted between May 21 and June 6 and final visits concluded by July 11, 2008. After refraction, it was determined that 248 of these students were ineligible to participate: 187 students did not have ≥1 D of uncorrected refractive

Discussion

In this analysis we compared RMS with CS in a group of Chinese high school students with predominantly myopic refractive error. The study was designed to be able to detect a 15% difference in compliance rate, which was considered clinically significant. However, we found that compliance to spectacle wear was close to 50% for both groups. This result was supported by the equivalence of other outcome measures, namely: perceived value, rate of remakes, symptoms, and patterns of use. Ready-made

References (16)

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Cited by (0)

Manuscript no. 2009-26.

Financial Disclosure(s): Support for this project was provided by the Michael and Susan Dell Foundation, by Helen Keller International (YZ, MH, & DF), Australian National Health and Medical Research Council Sidney Sax post doctoral fellowship (LK) and a Knights Templar Eye Foundation Pediatric Ophthalmology Grant (LK & BM). Mingguang He is supported by a grant from the World Bank to test a proprietary spectacle technology.

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