GlaucomaIGPSNCT01145911
The Study of Ocular Hemodynamics With Glaucoma Progression
An observational study of Glaucoma, run by Indiana University at 1 site in United States.
Trial summary
To determine the relationships between ocular hemodynamics and glaucomatous optic neuropathy progression. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Glaucoma
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to 3 Jul 2014
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glaucoma 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
Indiana University School of Medicine, Department of Ophthalmology
Indianapolis, Indiana, 46202
About this study
To determine the relationships between ocular hemodynamics and glaucomatous optic neuropathy progression.
Read the detailed description
- To determine whether baseline ocular blood flow values are predictive of glaucomatous progression as determined by visual field analysis.
- To determine how changes in ocular blood flow are related to visual field progression.
- To determine how changes in ocular blood flow are related to changes in optic nerve structure and topographic change over time.
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Blood Flow, Progression
- Medical subject headings
- Glaucoma, Disease Progression
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 |
|---|---|---|
| Glaucoma patients | Glaucoma patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Blood Flow
per visit
Measured: various
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJan 2008
- Primary completion3 Jul 2014
- Study completion3 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alon Harris, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145911
- Sponsor's protocol ID
- IGPS
- Acronym
- IGPS
- Status last verified
- Mar 2017
- First submitted
- 15 Jun 2010
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Verticchio Vercellin AC, Harris A, Oddone F, Siesky B, Eckert G, Belamkar A, Antman G, Segev F. Ocular blood flow biomarkers may predict long-term glaucoma progression. Br J Ophthalmol. 2024 Jun 20;108(7):946-950. doi: 10.1136/bjo-2022-322644.
PubMed 37852742
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Ocular Hemodynamics With Glaucoma Progression
- ClinicalTrials.gov ID
- NCT01145911
- Acronym / sponsor ID
- IGPS / IGPS
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Blood Flow, Progression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- 3 Jul 2014 (actual)
- Study completion
- 3 Jul 2014 (actual)
- First posted
- 17 Jun 2010 (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.
To determine the relationships between ocular hemodynamics and glaucomatous optic neuropathy progression.
Detailed description
- To determine whether baseline ocular blood flow values are predictive of glaucomatous progression as determined by visual field analysis.
- To determine how changes in ocular blood flow are related to visual field progression.
- To determine how changes in ocular blood flow are related to changes in optic nerve structure and topographic change over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glaucoma patients | – | –Glaucoma patients |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma 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
Ocular Blood Flow
Time frame: various
per visit
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 7 Mar 2017.
- Derived from this study: PubMed 37852742Verticchio Vercellin AC, Harris A, Oddone F, Siesky B, Eckert G, Belamkar A, Antman G, Segev F. Ocular blood flow biomarkers may predict long-term glaucoma progression. Br J Ophthalmol. 2024 Jun 20;108(7):946-950. doi: 10.1136/bjo-2022-322644.
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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 7 Mar 2017. 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?
Ocular Blood Flow (time frame: various). 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 NCT01145911, which also lists 1 linked publication.
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 7 Mar 2017.