HealthyNCT01333891
Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure
A study testing Phenylephrine, Sodium-Nitroprusside and Suction Cup in people with Healthy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Age-related macular degeneration (AMD) and glaucoma are among the leading causes of blindness in the western world. Elevated intraocular pressure (IOP) is a well known major risk factor for glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Phenylephrine, Sodium-Nitroprusside and Suction Cup
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2012to Dec 2012
- Phase
- Interventional
- 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
Who may be able to join
- Men and women aged between 18 and 35 years, nonsmokers
- Men and women will be included in equal parts
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia less than 1 diopter
Who cannot join
- 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 oral contraceptives)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks History of hypersensitivity to the trial drugs or to drugs with a similar chemical structure
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
- History of migraine
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Age-related macular degeneration (AMD) and glaucoma are among the leading causes of blindness in the western world. Elevated intraocular pressure (IOP) is a well known major risk factor for glaucoma. In addition, there is growing evidence that vascular factors, including arterial hypertension and hypotension, may play a role in the pathogenesis of AMD and glaucoma. To gain more insight into these mechanisms in humans is the primary goal of the present study.
Optical coherence tomography (OCT) delivers three dimensional, volumetric reflectivity information through transparent media in vivo. Moreover, the images show a high choroidal penetration and a resolution comparable to an histologic examination when infrared light sources are used. Because of its non-invasive character, OCT provides an ideal method for diagnosis and monitoring of retinal and choroidal abnormalities.
The present study aims to investigate whether choroidal thickness is temporarily altered by changes in IOP or systemic hemodynamic parameters. IOP will be increased by the use of a suction cup technique, mean arterial blood pressure will be altered by intravenously administered Phenylephrine or Sodium-Nitroprusside.
- Conditions
- Healthy
- Being tested
- Phenylephrine, Sodium-Nitroprusside, Suction Cup, Goldmann applanation tonometer, 1060nm Optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
Sodium-NitroprussideDrug
Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
Suction CupDevice
experimental stepwise increase of intraocular pressure while measurement of choroidal thickness suction force of 25, 50, 75, and 100 mmH
Goldmann applanation tonometerDevice
intraocular pressure measurements
1060nm Optical coherence tomographyDevice
Optical coherence tomography is a widely used non-invasive method to image the retina and choroid. Using a 1060nm light source coupled to a commercially available OCT system (Heidelberg Engineering, Heidelberg, Germany) allows for the measurement of choroidal thickness
| Study group | Role | What they receive |
|---|---|---|
| Sodium-Nitroprusside | Active comparator | Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes Receives: Drug: Phenylephrine; Drug: Sodium-Nitroprusside; Device: Suction Cup; Device: Goldmann applanation tonometer; Device: 1060nm Optical coherence tomography |
| Phenylephrine | Active comparator | Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes Receives: Drug: Phenylephrine; Drug: Sodium-Nitroprusside; Device: Suction Cup; Device: Goldmann applanation tonometer; Device: 1060nm Optical coherence tomography |
| Suction Cup | Active comparator | suction force of 25, 50, 75, and 100 mmHg Receives: Drug: Phenylephrine; Drug: Sodium-Nitroprusside; Device: Suction Cup; Device: Goldmann applanation tonometer; Device: 1060nm Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness
Measured: 18 months
Secondary outcomes (2)
Systolic/diastolic blood pressure (non-invasive)
Measured: 18 months
Intraocular pressure (IOP)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startDec 2012
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
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
- Investigators
- Gerhard Garhöfer, MD, PD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333891
- Sponsor's protocol ID
- OPHT-151010
- Status last verified
- Nov 2014
- First submitted
- 11 Apr 2011
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure
- ClinicalTrials.gov ID
- NCT01333891
- Acronym / sponsor ID
- OPHT-151010
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2012 (actual)
- First posted
- 12 Apr 2011 (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.
Age-related macular degeneration (AMD) and glaucoma are among the leading causes of blindness in the western world. Elevated intraocular pressure (IOP) is a well known major risk factor for glaucoma. In addition, there is growing evidence that vascular factors, including arterial hypertension and hypotension, may play a role in the pathogenesis of AMD and glaucoma. To gain more insight into these mechanisms in humans is the primary goal of the present study.
Optical coherence tomography (OCT) delivers three dimensional, volumetric reflectivity information through transparent media in vivo. Moreover, the images show a high choroidal penetration and a resolution comparable to an histologic examination when infrared light sources are used. Because of its non-invasive character, OCT provides an ideal method for diagnosis and monitoring of retinal and choroidal abnormalities.
The present study aims to investigate whether choroidal thickness is temporarily altered by changes in IOP or systemic hemodynamic parameters. IOP will be increased by the use of a suction cup technique, mean arterial blood pressure will be altered by intravenously administered Phenylephrine or Sodium-Nitroprusside.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sodium-Nitroprusside | Active comparator | Drug: Phenylephrine, Drug: Sodium-Nitroprusside, Device: Suction Cup, Device: Goldmann applanation tonometer, Device: 1060nm Optical coherence tomographyNipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes |
| Phenylephrine | Active comparator | Drug: Phenylephrine, Drug: Sodium-Nitroprusside, Device: Suction Cup, Device: Goldmann applanation tonometer, Device: 1060nm Optical coherence tomographyNeosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes |
| Suction Cup | Active comparator | Drug: Phenylephrine, Drug: Sodium-Nitroprusside, Device: Suction Cup, Device: Goldmann applanation tonometer, Device: 1060nm Optical coherence tomographysuction force of 25, 50, 75, and 100 mmHg |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women aged between 18 and 35 years, nonsmokers
- Men and women will be included in equal parts
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant
- Normal ophthalmic findings, ametropia less than 1 diopter
Key exclusion criteria (7 listed)
- 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 oral contraceptives)
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Blood donation during the previous 3 weeks History of hypersensitivity to the trial drugs or to drugs with a similar chemical structure
- History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
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 |
|---|---|---|
| PhenylephrineNeosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes | Drug | Phenylephrine, Sodium-Nitroprusside, Suction Cup |
| Sodium-NitroprussideNipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes | Drug | Phenylephrine, Sodium-Nitroprusside, Suction Cup |
| Suction Cupexperimental stepwise increase of intraocular pressure while measurement of choroidal thickness suction force of 25, 50, 75, and 100 mmH | Device | Phenylephrine, Sodium-Nitroprusside, Suction Cup |
| Goldmann applanation tonometerintraocular pressure measurements | Device | Phenylephrine, Sodium-Nitroprusside, Suction Cup |
| 1060nm Optical coherence tomographyOptical coherence tomography is a widely used non-invasive method to image the retina and choroid. Using a 1060nm light source coupled to a commercially available OCT system (Heidelberg Engineering, Heidelberg, Germany) allows for the measurement of choroidal thickness | Device | Phenylephrine, Sodium-Nitroprusside, Suction Cup |
Primary outcome
Choroidal thickness
Time frame: 18 months
2 secondary outcomes
Systolic/diastolic blood pressure (non-invasive)
Time frame: 18 months
Intraocular pressure (IOP)
Time frame: 18 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2014.
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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.
Gerhard Garhöfer, MD, PD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phenylephrine, Sodium-Nitroprusside and Suction Cup in people with Healthy, 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Nov 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 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 was stopped early. Results are not available in the source record.
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?
Choroidal thickness (time frame: 18 months). 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 14 Nov 2014; AzTrials last refreshed its copy on 6 Nov 2026.