Does Lowering Eye Pressure Affect the Results Obtained From Objective Visual Field Testing?

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wills Eye
ClinicalTrials.gov Identifier:
NCT00799994
First received: November 28, 2008
Last updated: December 2, 2008
Last verified: November 2008
  Purpose

A study to determine whether a patient's range of vision test results improve after their eye pressure is lowered by 30% or more by testing on a new machine called the Accumap and how to learn how much the Accumap's results change from one test to another within the same person.

The investigators believe that Multifocal VEP readings (Accumap)(and therefore visual function and ganglion cell function) improve after acutely lowering intraocular pressure.


Condition
Glaucoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Acutely Lowering Intraocular Pressure on Multifocal Visual Evoked Potential Testing

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • lowering of intraocular pressure will cause an acute improvement in MfVEP (multifocal visually evoked potential) amplitude readings [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: October 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients that have medical intervention in an attempt to lower intraocular pressure (oral or topical)
2
Patients who have received no intervention

Detailed Description:

Accumap testing will be performed before and two to three hours after treatment is initiated to lower IOP. In eye that have bilateral treatment, one eye will be assigned randomly to the study. The mean multifocal objective perimetry amplitude will be compared before and after IOP reduction. Also, the mean amplitudes of five circumferential zones will be compared before and after IOP lowering. Visual field testing and HRT testing will be performed before and after treatment as well if possible. Paired t-tests will be performed no pre-and post-treatment mean MOP amplitude values and circumferential zones to determine statistical significance. A second group of patients whose pressures will not be lowered will also be tested with Accumap at baseline and two hours afterwards, in order to examine reproducibility of mean MOP amplitude and mean circumferential amplitude. HVF and HRT testing will also be obtained on thes patients when possible.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

glaucoma service

Criteria

Inclusion Criteria:

  • Consecutive patients seen that have their intraocular pressures lowered by at least 30% over the course of two hours.

Exclusion Criteria:

  • Recent (within 6 weeks) intraocular surgery
  • Visual acuity worse than 20/40
  • Pathology unrelated to glaucoma (retinal disease, stroke, brain tumor, etc) associated with visual field defect
  • Prior corneal transplant, corneal edema, or corneal diseases such as keratoconus or dense scarring
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799994

Locations
United States, Pennsylvania
Wills Eye
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Pfizer
Investigators
Principal Investigator: L. Jay Katz, MD Wills Eye Institute
  More Information

No publications provided

Responsible Party: L. Jay Katz, MD, Wills Eye Institute
ClinicalTrials.gov Identifier: NCT00799994     History of Changes
Other Study ID Numbers: 04-653
Study First Received: November 28, 2008
Last Updated: December 2, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
glaucoma
intraocular pressure
multifocal visually evoked potentials

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 28, 2014