The Contact Lenses and Myopia Progression (CLAMP) Study will serve two purposes: 1) it will provide the training mechanism for Jeffrey J. Walline, O.D. to become a successful independent investigator and 2) it will evaluate the effect of rigid contact lenses on myopia progression in children. The CLAMP Study applies itself very well to furthering Dr. Walline's education and clinical experience. The CLAMP Study will generate the basis for Dr. Walline's qualifying examinations and his doctoral thesis, which will focus on his coursework in Physiological Optics and Preventive Medicine. Dr. Walline will serve as Principal Investigator and will gain valuable experience in all aspects of clinical research. He will be responsible for the recruitment, retention, ocular examination, and contact lens fitting of 110 children, most data collection, all data input and analysis, and the administrative functions of the entire study. The training plan, combined with the wide range of responsibilities in conducting this small-scale study, will produce an independent clinician-scientist who has learned the trials and tribulations of clinical research by direct application of his training and by personal experience. The CLAMP Study will examine the effects of rigid contact lenses on myopia progression in nearsighted children over a three-year period and will attempt to determine the mechanism of treatment effect if one exists. We will conduct a single-masked, randomized clinical trial on 110 children ages 8 to 11 years old who have between -1.00 D and -3.00 D (spherical component) of myopia in each eye, less than 1.00 D of astigmatism in both eyes, less than 1.00 D of anisometropia, no ocular or systemic health problems that may affect vision, and at least 20/20 best corrected visual acuity in both eyes. All subjects will be given a comprehensive baseline examination and fitted with rigid contact lenses; those who meet the minimum requirements for rigid contact lens adaptation will be randomized to the experimental group (rigid contact lenses) or to the control group (soft contact lenses). Annual examinations will be given to all children to determine their myopic progression, and to measure their ocular components. Their vision correction will be updated every six months. The CLAMP Study is the ideal scope and size of study to train Dr. Walline to become an independent investigator and has the potential to change the standard of care for young children who become nearsighted.
| Walline, J J; Mutti, D O; Zadnik, K et al. (1998) Development of phoria in children. Optom Vis Sci 75:605-10 |
