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

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ClinicalTrials.gov Identifier: NCT00799994
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
L. Jay Katz MD, Wills Eye

Brief Summary:

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 or disease
Glaucoma

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.

Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Acutely Lowering Intraocular Pressure on Multifocal Visual Evoked Potential Testing
Study Start Date : October 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Group/Cohort
1
Patients that have medical intervention in an attempt to lower intraocular pressure (oral or topical)
2
Patients who have received no intervention



Primary Outcome Measures :
  1. lowering of intraocular pressure will cause an acute improvement in MfVEP (multifocal visually evoked potential) amplitude readings [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: L. Jay Katz MD, Glaucoma Service Chief, Wills Eye
ClinicalTrials.gov Identifier: NCT00799994     History of Changes
Other Study ID Numbers: 04-653
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by L. Jay Katz MD, Wills Eye:
glaucoma
intraocular pressure
multifocal visually evoked potentials

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases