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