Relationship Between Intraocular Pressure Fluctuation and Retinal Ganglion Cell Function in Eyes Receiving Latanoprost 0.005% Versus Placebo
It has been hypothesized that intraocular (IOP) variability is an independent risk factor
for the progression of glaucoma. IOP variability includes 24 hour IOP fluctuation during the
waking period (diurnal fluctuation) and sleep period (nocturnal fluctuation) as well as
longitudinal IOP variability measured in the diurnal period over the course of multiple
office visits.
Latanoprost has been clinically used to lower eye pressure in glaucoma and ocular
hypertension for almost 10 years. Latanoprost 0.005% has been demonstrated to provide
superior ocular hypotensive efficacy compared with timolol 0.5% in pivotal phase 3 clinical
trials (Alm et al. 1995; Camras 1996).
The Pattern Electroretinogram (PERG) is a non-invasive technology that objectively measures
the retinal ganglion cell (RGC) function (Porciatti and Ventura 2004). A recent study has
demonstrated that the RGC function can be improved following IOP reduction in glaucomatous
eyes with early visual field defects (Ventura and Porciatti 2005).
The purpose of this investigation is to evaluate the relationship between IOP fluctuation,
RGC dysfunction, and optic nerve and retinal nerve fiber layer (RNFL) thickness changes in
patients with glaucoma and ocular hypertension receiving latanoprost 0.005% versus placebo.
Observational
Observational Model: Case-Crossover, Time Perspective: Prospective
David S Greenfield, MD
Principal Investigator
University of Miami Bascom Palmer Eye Institute
United States: Institutional Review Board
20057259
NCT01042665
February 2006
December 2009
Name | Location |
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University of Miami Bascom Palmer Eye Institute | Palm Beach Gardens, Florida 33418 |