Retinal BloodflowNCT03398616
Regulation of Retinal Bloodflow Pressure
An observational study of Retinal Bloodflow, run by Gerhard Garhofer at 1 site in Austria.
Trial summary
Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Retinal Bloodflow
- How many people
- 17 participants
- Where
- 1 siteAustria
- Study dates
- 29 Mar 2018to 31 Dec 2018
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 16 healthy subjects
Who may be able to join
- Men and women aged between 18 and 35 years
- Non-smokers
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 1 Dpt.
- Exclusion Criteria:- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
- Treatment in the previous 3 weeks with any drug (except contraceptives)
Show all 9Show fewer
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks
- Pregnancy, planned pregnancy or lactating
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, A-1090
About this study
Official title: Regulation of Retinal Blood Flow in Response to an Experimental Increase in Intraocular Pressure
Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale studies have shown that reduced ocular perfusion pressure is an important risk factor for the prevalence, the incidence and the progression of primary open angle glaucoma. There is also evidence that autoregulation is impaired in patients with primary open angle glaucoma.
To gain more insight into these phenomena in humans is the primary goal of the present study.
The present study aims to investigate the pressure/flow relationship as a measure for retinal blood flow autoregulation during an experimental increase in intraocular pressure by the use of the suction cup technique. Retinal blood flow will be measured by Doppler OCT.
- Conditions
- Retinal Bloodflow
- Keywords
- Retinal Bloodflow Pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal pressure-flow-relationship as assessed with FDOCT
Measured: 01.02.2018-31.12.2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start29 Mar 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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 Retinal BloodflowStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerhard Garhofer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398616
- Sponsor's protocol ID
- OPHT-080515
- Status last verified
- Aug 2019
- First submitted
- 8 Jan 2018
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Puchner S, Schmidl D, Ginner L, Augustin M, Leitgeb R, Szegedi S, Stjepanek K, Hommer N, Kallab M, Werkmeister RM, Schmetterer L, Garhofer G. Changes in Retinal Blood Flow in Response to an Experimental Increase in IOP in Healthy Participants as Assessed With Doppler Optical Coherence Tomography. Invest Ophthalmol Vis Sci. 2020 Feb 7;61(2):33. doi: 10.1167/iovs.61.2.33.
PubMed 32084274
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Retinal Blood Flow in Response to an Experimental Increase in Intraocular Pressure
- ClinicalTrials.gov ID
- NCT03398616
- Acronym / sponsor ID
- OPHT-080515
- Conditions
- Retinal Bloodflow
- Keywords
- Retinal Bloodflow Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Gerhard GarhoferUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Jan 2018 (actual)
- 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.
Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale studies have shown that reduced ocular perfusion pressure is an important risk factor for the prevalence, the incidence and the progression of primary open angle glaucoma. There is also evidence that autoregulation is impaired in patients with primary open angle glaucoma.
To gain more insight into these phenomena in humans is the primary goal of the present study.
The present study aims to investigate the pressure/flow relationship as a measure for retinal blood flow autoregulation during an experimental increase in intraocular pressure by the use of the suction cup technique. Retinal blood flow will be measured by Doppler OCT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 16 healthy subjects
Key inclusion criteria (9 listed)
- Men and women aged between 18 and 35 years
- Non-smokers
- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropy < 1 Dpt.
- Exclusion Criteria:- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
Key exclusion criteria (0 listed)
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
Retinal pressure-flow-relationship as assessed with FDOCT
Time frame: 01.02.2018-31.12.2018
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 20 Aug 2019.
- Derived from this study: PubMed 32084274Puchner S, Schmidl D, Ginner L, Augustin M, Leitgeb R, Szegedi S, Stjepanek K, Hommer N, Kallab M, Werkmeister RM, Schmetterer L, Garhofer G. Changes in Retinal Blood Flow in Response to an Experimental Increase in IOP in Healthy Participants as Assessed With Doppler Optical Coherence Tomography. Invest Ophthalmol Vis Sci. 2020 Feb 7;61(2):33. doi: 10.1167/iovs.61.2.33.
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 Retinal Bloodflow, run by Gerhard Garhofer 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 9 inclusion and 0 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 20 Aug 2019. 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?
Retinal pressure-flow-relationship as assessed with FDOCT (time frame: 01.02.2018-31.12.2018). 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 NCT03398616, 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 20 Aug 2019.