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Posters
November 2002
CUMULATIVE EXPERIENCE OF EXTENDED
WEAR CLINICAL TRIALS OF A SILICONE HYDROGEL CONTACT LENS.
Frederick Edmunds OD, FAAO, Timothy Comstock OD, FAAO, Thomas
Crescuillo, William Reindel OD, Bausch & Lomb, Inc.
Purpose:
The launch of silicone hydrogel contact
lenses has ushered in a new era of extended wear. Eye care
practitioners, as well as potential wearers have approached
this previously popular modality with caution based on the
historical record and negative perceptions of extended wear
with conventional hydrogel lenses. A key concern of the
profession regarding this modality is incidence of microbial
keratitis (MK). The purpose of this poster is to report
the cumulative experience of controlled extended wear clinical
trials for PureVision (balafilcon A) contact lenses with
regard to patient-years and incidence of sight threatening
adverse events (e.g. MK).
Method:
The results of 27 extended
wear studies with Bausch & Lomb's PureVision (balafilcon
A) silicone hydrogel lens were reviewed and analyzed for cumulative
wearing experience and serious adverse events including MK.
Results:
Over 4,700 patients have
completed 27 extended wear studies. These studies ranged in
length from 2 weeks to 1.5 years, and provided over 2200 patient-years
of data. There were no reports of MK or other sight-threatening
adverse events. Other clinical signs were within expected
norms.
Conclusions:
Based on the conclusion
of the Contact Lens Institute (CLI) study, and on the number
of patient-years (>2,200) accumulated in our extended
wear clinical trials, one would estimate that five events
of MK would have been observed. While an incidence rate
of MK has not yet been established, these clinical finding
suggest that the incidence of MK or other sight-threatening
events, will be less than that reported in the landmark
CLI study of conventional hydrogel lenses.
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