Aqueous Suppressant Versus Aqueous Outflow on Ocular Blood Flow

An observational study of Glaucoma, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study will be to compare the aqueous production suppressant to aqueous outflow drugs in terms of the response to known vascular parameters. Specifically; systemic perfusion pressure, retrobulbar blood flow and retinal microcirculation. Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Glaucoma
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Mar 2011to Oct 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 120 glacuoma patients

Who may be able to join

Patients will meet all of the following inclusion criteria to enter the study:
Age: 30 years or older.
Diagnosis: confirmed open-angle glaucoma in at least one eye:
glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
glaucomatous optic disc cupping
agreement between two baseline exams for reliability
Best corrected visual acuity at least 20/60 in at least one eye.
Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).

Who cannot join

Extensive Humphrey visual field damage consisting of either a mean deviation (MD) < -15 decibels or a clinically determined threat to fixation in both hemifields.
Evidence of exfoliation or pigment dispersion.
History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
History or signs of intraocular trauma.
Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.

Show all 11Show fewer

Any abnormality preventing reliable applanation tonometry.
Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
Cataract surgery within the past year.
Resting pulse < 50 beats per minute.
Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

Department of Ophthalmology Indiana University School of Medicine
Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Examination of the Effect of Aqueous Suppressant Versus Aqueous Outflow Enhancing Glaucoma Medications on Ocular Perfusion Pressure and Blood Flow: A Mechanistic Study

Read the detailed description

A comparison of perfusion pressure, retinal microcirculation utilizing Heidelberg Retinal Flowmetry and retrobulbar circulation utilizing color Doppler ultrasound imaging

Conditions: Glaucoma
Keywords: glaucoma blood flow
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01308788
Study group	Role	What they receive
aqueous suppressant		aqueous suppressant treated
aqueous outflow		aqueous outflow treated

What is being measured

The primary outcome is the main question the study is designed to answer.

6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
Measured: Baseline and 6 month visits
6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)
Measured: Baseline and 6 month visits
6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)
Measured: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
Measured: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
Measured: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
Measured: Baseline and 6 month visits
6-month Change in Ocular Perfusion Pressures (OPP)
Measured: Baseline and 6 month visits
2-year Change in OA PSV
Measured: Baseline and 24 month visits
2-year Change in OA EDV
Measured: Baseline and 24 month visits
2-year Change in OA RI
Measured: Baseline and 24 month visits
2-year Change in CRA PSV
Measured: Baseline and 24 month visits
2-year Change in CRA EDV
Measured: Baseline and 24 month visits
2-year Change in CRA RI
Measured: Baseline and 24 month visits
2-year Change in OPP
Measured: Baseline and 24 month visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Oct 2012

First posted4 Mar 2011 (estimated)
Study startMar 2011
Primary completionOct 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
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: Cohort
Time perspective: Prospective
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01308788
Sponsor's protocol ID: IGPS-prost-OAG
Status last verified: Jan 2014
First submitted: 2 Mar 2011
Last updated: 27 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examination of the Effect of Aqueous Suppressant Versus Aqueous Outflow Enhancing Glaucoma Medications on Ocular Perfusion Pressure and Blood Flow: A Mechanistic Study
ClinicalTrials.gov ID: NCT01308788
Acronym / sponsor ID: IGPS-prost-OAG
Conditions: Glaucoma
Keywords: glaucoma blood flow
Study type: Observational
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: Mar 2011
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 4 Mar 2011 (estimated)
Results: Posted 27 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A comparison of perfusion pressure, retinal microcirculation utilizing Heidelberg Retinal Flowmetry and retrobulbar circulation utilizing color Doppler ultrasound imaging

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
aqueous suppressant	–	–aqueous suppressant treated
aqueous outflow	–	–aqueous outflow treated

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 120 glacuoma patients

Key inclusion criteria (8 listed)

Age: 30 years or older.
Diagnosis: confirmed open-angle glaucoma in at least one eye:
Best corrected visual acuity at least 20/60 in at least one eye.
Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).

Key exclusion criteria (11 listed)

Extensive Humphrey visual field damage consisting of either a mean deviation (MD) < -15 decibels or a clinically determined threat to fixation in both hemifields.
Evidence of exfoliation or pigment dispersion.
History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
History or signs of intraocular trauma.

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

6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
Time frame: Baseline and 6 month visits
6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)
Time frame: Baseline and 6 month visits
6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)
Time frame: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
Time frame: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
Time frame: Baseline and 6 month visits
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
Time frame: Baseline and 6 month visits
6-month Change in Ocular Perfusion Pressures (OPP)
Time frame: Baseline and 6 month visits
2-year Change in OA PSV
Time frame: Baseline and 24 month visits
2-year Change in OA EDV
Time frame: Baseline and 24 month visits
2-year Change in OA RI
Time frame: Baseline and 24 month visits
2-year Change in CRA PSV
Time frame: Baseline and 24 month visits
2-year Change in CRA EDV
Time frame: Baseline and 24 month visits
2-year Change in CRA RI
Time frame: Baseline and 24 month visits
2-year Change in OPP
Time frame: Baseline and 24 month visits

Results and safety

Results posted to the registry on 27 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aqueous Outflow	14	14
Aqueous Suppressant	21	21

Primary outcome: 6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)

Time frame: Baseline and 6 month visits. Mean (Standard Error). Unit: cm/sec

Measure	Aqueous Outflow n = 14	Aqueous Suppressant n = 21
Value	-.70 (2.57)	1.84 (.96)

Aqueous Outflow vs Aqueous Suppressant: p = .4414, ANCOVA

Primary outcome: 6-month Change in Phthalmic Artery (OA) End Diastolic Velocity (EDV)

Time frame: Baseline and 6 month visits. Mean (Standard Error). Unit: cm/sec

Measure	Aqueous Outflow n = 14	Aqueous Suppressant n = 21
Value	-.36 (.78)	.12 (.44)

Aqueous Outflow vs Aqueous Suppressant: p = .7820, ANCOVA

Primary outcome: 6-month Change in Phthalmic Artery (OA) Vascular Resistance (RI)

Time frame: Baseline and 6 month visits. Mean (Standard Error). Unit: unitless

Measure	Aqueous Outflow n = 14	Aqueous Suppressant n = 21
Value	.003 (.011)	.014 (.013)

Aqueous Outflow vs Aqueous Suppressant: p = .5496, ANCOVA

Primary outcome: 6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)

Time frame: Baseline and 6 month visits. Mean (Standard Error). Unit: cm/sec

Measure	Aqueous Outflow n = 14	Aqueous Suppressant n = 21
Value	-.16 (.28)	.09 (.25)

Aqueous Outflow vs Aqueous Suppressant: p = .2930, ANCOVA

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aqueous Outflow	0 of 0	0 of 0	Not reported
Aqueous Suppressant	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Small number of subjects at final endpoint, participation number various by analysis and date

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Alon Harris, PhD principal investigator

Indiana University

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 Indiana University 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 8 inclusion and 11 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 27 Jan 2014. 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?

Yes. Results are posted in the registry (first posted 27 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV) (time frame: Baseline and 6 month visits). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01308788.

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 27 Jan 2014.