NCT00799994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

November 28, 2008

Last Update Submit

November 20, 2016

Conditions

Glaucoma

Keywords

glaucomaintraocular pressuremultifocal visually evoked potentials

Outcome Measures

Primary Outcomes (1)

  • lowering of intraocular pressure will cause an acute improvement in MfVEP (multifocal visually evoked potential) amplitude readings

    1 day

Study Arms (2)

1

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

2

Patients who have received no intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

glaucoma service

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wills Eye

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • L. Jay Katz, MD

    Wills Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Glaucoma Service Chief

Study Record Dates

First Submitted

November 28, 2008

First Posted

December 1, 2008

Study Start

October 1, 2004

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

November 22, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)