Abstract
Concern for microbial keratitis (MK) has been a limiting factor regarding practitioner acceptance of the safety of continuous wear. Nearly 5,800 subjects participated in 27 extended-wear clinical trials of PureVision™ silicone hydrogel lenses coordinated by the Clinical Research Group at Bausch & Lomb. There were no reports of MK in over 2,200 patient-years of experience accumulated in these studies. In an attempt to gain insight into the safety of silicone hydrogel lenses, information from market experience and postmarket product performance data was utilized to extrapolate a prospective incident rate of MK with these lenses. With >2 years of experience in the market it appears that the incident rate of MK for PureVision™ lenses, utilized in all modalities, is tracking lower than that of conventional hydrogel lenses.
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