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

NCT ID: NCT00799994

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Glaucoma

Keywords

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glaucoma intraocular pressure multifocal visually evoked potentials

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients that have medical intervention in an attempt to lower intraocular pressure (oral or topical)

No interventions assigned to this group

2

Patients who have received no intervention

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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L. Jay Katz MD

Glaucoma Service Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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L. Jay Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Wills Eye Institute

Locations

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Wills Eye

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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04-653

Identifier Type: -

Identifier Source: org_study_id