GlaucomaNCT02292381
Blood Flow Regulation in Glaucoma
An observational study of Glaucoma, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- Isometric exercise
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2014to 28 Nov 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 60 open angle glaucoma patients 60 healthy age- and sex matched controls
Who may be able to join
- Patients with open angle glaucoma:
- Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated intraocular pressure ≥ 21 mmHg on at least three measurements in the medical history. Mean deviation in the visual field test < 10 decibel
- Healthy control subjects:
- normal ophthalmic findings and intraocular pressure < 20 mmHg on at least three measurements
- no evidence of increased intraocular pressure in the medical history
- no signs of glaucomatous damage in the optic disc or the glaucoma hemifield test
Who cannot join
- Presence or history of a severe medical condition as judged by the investigator
- Abuse of alcoholic beverages
- Participation in a clinical trial in the 3 weeks preceding the study
- Exfoliation glaucoma
- Pigmentary glaucoma
- Secondary glaucoma
Show all 14Show fewer
- Ocular hypertension
- History of acute angle closure
- Intraocular surgery within the last 6 months
- History of epilepsia
- Diabetes mellitus
- Ocular inflammation or infection within the last 3 months
- Untreated hypertension with systolic blood pressure >160 mmHg, diastolic blood pressure >95 mmHg
- Pregnancy or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. Although increased intraocular pressure has been identified as the major risk factor for the development and the progression of the disease it has been speculated for a long time that impaired ocular blood flow may contribute to the pathogenesis of the disease. This concept has been supported by several epidemiological studies showing that low ocular perfusion pressure and small retinal vessel caliber are associated with the disease.
The proposed study tests the hypothesis that patients with glaucoma have reduced total retinal blood flow as compared to healthy subjects. Additionally, autoregulation of blood flow will be investigated during an increase in ocular perfusion pressure. This is of importance because it may clarify the degree of vascular involvement in glaucoma.
- Conditions
- Glaucoma
- Being tested
- Isometric exercise
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric exerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Glaucoma Patients | Patients with primary open angle glaucoma Receives: Other: Isometric exercise | |
| Healthy controls | age- and sex matched controls Receives: Other: Isometric exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic nerve head blood flow
Measured: once
Secondary outcomes (1)
Retinal blood flow
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startApr 2014
- Primary completion28 Nov 2016
- Study completion28 Nov 2016
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.
- More trials run by Medical University of ViennaThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292381
- Sponsor's protocol ID
- OPHT-250313
- Status last verified
- Aug 2021
- First submitted
- 22 Oct 2013
- Last updated
- 1 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Regulation in Glaucoma
- ClinicalTrials.gov ID
- NCT02292381
- Acronym / sponsor ID
- OPHT-250313
- Conditions
- Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- 28 Nov 2016 (actual)
- Study completion
- 28 Nov 2016 (actual)
- First posted
- 17 Nov 2014 (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.
Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. Although increased intraocular pressure has been identified as the major risk factor for the development and the progression of the disease it has been speculated for a long time that impaired ocular blood flow may contribute to the pathogenesis of the disease. This concept has been supported by several epidemiological studies showing that low ocular perfusion pressure and small retinal vessel caliber are associated with the disease.
The proposed study tests the hypothesis that patients with glaucoma have reduced total retinal blood flow as compared to healthy subjects. Additionally, autoregulation of blood flow will be investigated during an increase in ocular perfusion pressure. This is of importance because it may clarify the degree of vascular involvement in glaucoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Patients | – | Other: Isometric exercisePatients with primary open angle glaucoma |
| Healthy controls | – | Other: Isometric exerciseage- and sex matched controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 60 open angle glaucoma patients 60 healthy age- and sex matched controls
Key inclusion criteria (6 listed)
- Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated intraocular pressure ≥ 21 mmHg on at least three measurements in the medical history. Mean deviation in the visual field test < 10 decibel
- normal ophthalmic findings and intraocular pressure < 20 mmHg on at least three measurements
- no evidence of increased intraocular pressure in the medical history
- no signs of glaucomatous damage in the optic disc or the glaucoma hemifield test
Key exclusion criteria (14 listed)
- Presence or history of a severe medical condition as judged by the investigator
- Abuse of alcoholic beverages
- Participation in a clinical trial in the 3 weeks preceding the study
- Exfoliation glaucoma
- Pigmentary glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric exercise | Other | Glaucoma Patients, Healthy controls |
Primary outcome
Optic nerve head blood flow
Time frame: once
1 secondary outcome
Retinal blood flow
Time frame: once
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 1 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Medical University of Vienna at 1 site in Austria.
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 6 inclusion and 14 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 1 Sep 2021. 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 Austria. 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?
Optic nerve head blood flow (time frame: once). 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 1 Sep 2021.