Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Medical University of Vienna.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01333891
First received: April 11, 2011
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Healthy
Drug: Phenylephrine
Drug: Sodium-Nitroprusside
Device: Suction Cup
Device: Goldmann applanation tonometer
Device: 1060nm Optical coherence tomography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Choroidal thickness [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Systolic/diastolic blood pressure (non-invasive) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Intraocular pressure (IOP) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: October 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sodium-Nitroprusside
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
Drug: Phenylephrine
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
Drug: Sodium-Nitroprusside
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
Device: Suction Cup
experimental stepwise increase of intraocular pressure while measurement of choroidal thickness suction force of 25, 50, 75, and 100 mmH
Device: Goldmann applanation tonometer
intraocular pressure measurements
Device: 1060nm Optical coherence tomography
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
Active Comparator: Phenylephrine
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
Drug: Phenylephrine
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
Drug: Sodium-Nitroprusside
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
Device: Suction Cup
experimental stepwise increase of intraocular pressure while measurement of choroidal thickness suction force of 25, 50, 75, and 100 mmH
Device: Goldmann applanation tonometer
intraocular pressure measurements
Device: 1060nm Optical coherence tomography
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
Active Comparator: Suction Cup
suction force of 25, 50, 75, and 100 mmHg
Drug: Phenylephrine
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
Drug: Sodium-Nitroprusside
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
Device: Suction Cup
experimental stepwise increase of intraocular pressure while measurement of choroidal thickness suction force of 25, 50, 75, and 100 mmH
Device: Goldmann applanation tonometer
intraocular pressure measurements
Device: 1060nm Optical coherence tomography
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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333891

Contacts
Contact: Gerhard Garhöfer, MD, PD 0043140400 ext 2981 gerhard.garhoefer@meduniwien.ac.at

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Gerhard Garhöfer, MD, PD Department of Clinical Pharmacology, Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv. Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01333891     History of Changes
Other Study ID Numbers: OPHT-151010
Study First Received: April 11, 2011
Last Updated: August 9, 2012
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Phenylephrine
Oxymetazoline
Nitroprusside
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antihypertensive Agents
Vasodilator Agents
Nitric Oxide Donors

ClinicalTrials.gov processed this record on September 30, 2014