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Published, Version of Record (VoR)Open Access (License Unspecified), Open
Journal article
The Correction of Myopia Evaluation Trial: lessons from the study design
Annals of the Academy of Medicine, Singapore, v 33(1), pp 44-48
01 Jan 2004
PMID: 15008561
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
The Correction of Myopia Evaluation Trial (COMET), a multicentre clinical trial based in 4 schools of optometry in the United States, evaluated the effect of progressive addition lenses versus single vision lenses on myopia progression in an ethnically diverse group of 469 myopic children aged 6 to 11 years. Completion of the clinical trial phase of the study provides an opportunity to evaluate aspects of the study design that contribute to its success. This article describes aspects of the study design that were influential in ensuring the smooth conduct of COMET. These include a dedicated team of investigators, an organisational structure with strong leadership and an independent Co-ordinating Centre, regular communication among investigators, flexible and creative approaches to recruitment and retention, sensitivity to concerns for child safety and child participation, and methods for enhancing and monitoring data reliability. The experience with COMET has provided a number of valuable lessons for all aspects of the study design that should benefit the development and implementation of future clinical trials, particularly those done in similar populations of children. The use of a carefully designed protocol using standard methods by dedicated members of the study team is essential in ensuring achievement of the study aims.
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Details
- Title
- The Correction of Myopia Evaluation Trial: lessons from the study design
- Creators
- L Hyman - Stony Brook UniversityJ Gwiazda - New England College of OptometryCOMET GroupMitchell Scheiman - Pennsylvania College of Optometry (PCO)
- Publication Details
- Annals of the Academy of Medicine, Singapore, v 33(1), pp 44-48
- Grant note
- EY 11740 / NEI NIH HHS EY 1755 / NEI NIH HHS EY 11754 / NEI NIH HHS EY 11756 / NEI NIH HHS EY 11805 / NEI NIH HHS EY 11752 / NEI NIH HHS
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Pennsylvania College of Optometry (PCO)
- Web of Science ID
- WOS:000189100700009
- Scopus ID
- 2-s2.0-1842812557
- Other Identifier
- 991021900185704721
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Data related to this publication, from InCites Benchmarking & Analytics tool:
- Web of Science research areas
- Ophthalmology