GlaucomaNCT00799994
Does Lowering Eye Pressure Affect the Results Obtained From Objective Visual Field Testing?
An observational study of Glaucoma, run by Wills Eye at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- Type of treatment
- Pill or oral medicine
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: glaucoma service
Who may be able to join
- Consecutive patients seen that have their intraocular pressures lowered by at least 30% over the course of two hours.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Acutely Lowering Intraocular Pressure on Multifocal Visual Evoked Potential Testing
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.
Read the 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.
- Conditions
- Glaucoma
- Keywords
- glaucoma, intraocular pressure, multifocal visually evoked potentials
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients that have medical intervention in an attempt to lower intraocular pressure (oral or topical) | |
| 2 | Patients who have received no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
lowering of intraocular pressure will cause an acute improvement in MfVEP (multifocal visually evoked potential) amplitude readings
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startOct 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, L. Jay Katz MD, Wills Eye
- Investigators
- L. Jay Katz, MD, Principal investigator, Wills Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799994
- Sponsor's protocol ID
- 04-653
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2008
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acutely Lowering Intraocular Pressure on Multifocal Visual Evoked Potential Testing
- ClinicalTrials.gov ID
- NCT00799994
- Acronym / sponsor ID
- 04-653
- Conditions
- Glaucoma
- Keywords
- glaucoma, intraocular pressure, multifocal visually evoked potentials
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 1 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients that have medical intervention in an attempt to lower intraocular pressure (oral or topical) |
| 2 | – | –Patients who have received no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- glaucoma service
Key inclusion criteria (1 listed)
- Consecutive patients seen that have their intraocular pressures lowered by at least 30% over the course of two hours.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
lowering of intraocular pressure will cause an acute improvement in MfVEP (multifocal visually evoked potential) amplitude readings
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
L. Jay Katz, MD principal investigator
Wills Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lowering of intraocular pressure will cause an acute improvement in MfVEP (multifocal visually evoked potential) amplitude readings (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.