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

NCT00799994

Last updated date
Study Location
Wills Eye
Philadelphia, Pennsylvania, 19107, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glaucoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title Does Lowering Eye Pressure Affect the Results Obtained From Objective Visual Field Testing?
Official Title Effect of Acutely Lowering Intraocular Pressure on Multifocal Visual Evoked Potential Testing
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.

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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population glaucoma service
Condition Glaucoma
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 28, 2008)
23
Original Actual Enrollment Same as current
Actual Study Completion Date January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00799994
Other Study ID Numbers 04-653
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Responsible Party L. Jay Katz MD, Wills Eye
Study Sponsor Wills Eye
Collaborators Pfizer
Investigators
Principal Investigator:L. Jay Katz, MDWills Eye Institute
PRS Account Wills Eye
Verification Date November 2016