The Correction of Myopia Evaluation Trial: lessons from the study design.
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.
Hyman
L
L
Department of Preventive Medicine, Stony Brook University, Stony Brook, New York 11794-8036, USA. lhyman@notes.cc.sunysb.edu
Gwiazda
J
J
D018450:Disease Progression; D006801:Humans; D007909:Lenses; D015337:Multicenter Studies as Topic; D009216:Myopia / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012189:Retrospective Studies