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Relationship Between Intraocular Pressure Fluctuation and Retinal Ganglion Cell Function in Eyes Receiving Latanoprost 0.005% Versus Placebo


N/A
18 Years
85 Years
Not Enrolling
Both
Glaucoma

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Trial Information

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.


Inclusion Criteria:



Inclusion Criteria - OHT:

- Ocular hypertension defined as an IOP ≥ 24 mm Hg and ≤ 32 mm Hg in one eye and IOP ≥
22 mm Hg and ≤ 32 mm Hg in the fellow eye

- Normal optic disc

- Normal visual field defined as follows:

- Mean Deviation (MD) or Pattern Standard Deviation (PSD) of p>5%

- Normal Glaucoma Hemifield Test (GHT)

- Reliable visual field exam (less than 33% false positives or false negatives, and
less than 20% fixation losses)

Inclusion Criteria - POAG:

- Glaucomatous visual field loss defined as a CPSD (p < 0.05), or GHT (p < 1%) outside
normal limits with consistent with ONH or NFL defect

- Early visual field loss defined as MD ≤ -6.0 dB

- Untreated IOP ≤ 32 mmHg

- ONH or NFL defect defined as either inter-eye CDR asymmetry > 0.2, rim thinning or
notching, or NFL bundle defect visible on slitlamp biomicroscopy and stereo color
fundus photography

Exclusion Criteria:

Exclusion Criteria - OHT:

- Best-corrected visual acuity less than 20/40 either eye

- Abnormal or unreliable VF

- Untreated IOP > 32 mmHg

- Age < 18 or >85 years

- Refractive error of > +3.00 D or < -7.00 D

- Previous intraocular surgery except for uncomplicated cataract extraction with
posterior chamber intraocular lens implantation

- Need for chronic ocular or systemic corticosteroid use

- Narrow/closed angle (gonioscopy must show 75% or more of the angle to be Grade 2 or
more by Shaffer's grading system)

- Diabetic retinopathy

- Other diseases that may cause VF loss or optic disc abnormalities

- Life-threatening or debilitating illness making it unlikely patient could
successfully complete the study

- Inability to clinically view or photograph the optic discs due to media opacity or
poorly dilating pupil

- Refusal of informed consent or of commitment to the full length of the study

- Contraindication to latanoprost or placebo vehicle

Exclusion criteria - POAG:

- Best-corrected visual acuity less than 20/40

- Untreated IOP > 32 mmHg

- Age < 18 or >85 years

- Refractive error of > +3.00 D or < -7.00 D

- Previous intraocular surgery except for uncomplicated cataract extraction with
posterior chamber intraocular lens implantation

- Diabetic retinopathy

- Other diseases that may cause VF loss or optic disc abnormalities

- Inability to clinically view or photograph the optic discs due to media opacity or
poorly dilating pupil

- Inability to perform reliably on automated VF testing

- Life-threatening or debilitating illness making it unlikely patient could
successfully complete the study.

- Refusal of informed consent or of commitment to the full length of the study

- Contraindication to latanoprost or placebo vehicle

Type of Study:

Observational

Study Design:

Observational Model: Case-Crossover, Time Perspective: Prospective

Principal Investigator

David S Greenfield, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami Bascom Palmer Eye Institute

Authority:

United States: Institutional Review Board

Study ID:

20057259

NCT ID:

NCT01042665

Start Date:

February 2006

Completion Date:

December 2009

Related Keywords:

  • Glaucoma
  • Glaucoma
  • intraocular pressure
  • latanoprost
  • retinal ganglion cell
  • pattern electroretinogram
  • Synovial Cyst
  • Ganglion Cysts
  • Glaucoma

Name

Location

University of Miami Bascom Palmer Eye Institute Palm Beach Gardens, Florida  33418