This proposal is for the University of Houston College of Optometry (UHCO) to serve as one of two clinical centers for the Soft Bifocal Contact Lens Myopia Control Study, a randomized clinical trial designed to answer 3 important issues related to slowing eye growth in myopic children. The answer to the first question will determine whether commercially available soft bifocal contact lenses slow myopia progression in children. Answers to the second and third questions will determine how soft bifocal contact lenses affect growth of the eye, in order to ultimately optimize signals that slow myopia progression in children. A total of 294 myopic children (7 to 11 years old) meeting the study's inclusion and exclusion criteria will be enrolled. The University of Houston Clinical Center will enroll 147 children. The children will be randomly assigned to wear either single-vision soft contact lenses or center-distance soft bifocal contact lenses and will be followed for at least three years using protocols standardized between the clinical centers. The primary outcome is the change in myopia as measured by cycloplegic auto refraction. Secondary outcomes include peripheral defocus while wearing contact lenses at distance and near, peripheral refractive error without a contact lens (eye shape), and central and peripheral eye length. This application details the UHCO Clinical Center's ability to recruit 147 myopic children in 15 months and to retain the children for at least three years of follow-up. We also document that UHCO has the personnel, experience, equipment, and facilities needed to successfully conduct this study in accordance with the study Manual of Procedures (MOP). Complete details regarding the study rationale, design, and methods are contained in the MOP, which is submitted with the Study Chair application. The other Clinical Center, Study Chair, and Data Coordinating Center are located at The Ohio State University.
Myopia affects approximately one-third of people in the United States, and approximately 60% (60 million) of them become myopic during childhood. The results of this study have the potential to affect the standard of care for young myopic children, and the results will lead to important information regarding optimization of the signals that may lead to slower eye growth and myopia progression.