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Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01333891
First Posted: April 12, 2011
Last Update Posted: November 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna
April 11, 2011
April 12, 2011
November 14, 2014
December 2012
December 2012   (Final data collection date for primary outcome measure)
Choroidal thickness [ Time Frame: 18 months ]
Same as current
Complete list of historical versions of study NCT01333891 on ClinicalTrials.gov Archive Site
  • Systolic/diastolic blood pressure (non-invasive) [ Time Frame: 18 months ]
  • Intraocular pressure (IOP) [ Time Frame: 18 months ]
Same as current
Not Provided
Not Provided
 
Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure
Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • 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: 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
    Interventions:
    • Drug: Phenylephrine
    • Drug: Sodium-Nitroprusside
    • Device: Suction Cup
    • Device: Goldmann applanation tonometer
    • Device: 1060nm Optical coherence tomography
  • 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
    Interventions:
    • Drug: Phenylephrine
    • Drug: Sodium-Nitroprusside
    • Device: Suction Cup
    • Device: Goldmann applanation tonometer
    • Device: 1060nm Optical coherence tomography
  • Active Comparator: Suction Cup
    suction force of 25, 50, 75, and 100 mmHg
    Interventions:
    • Drug: Phenylephrine
    • Drug: Sodium-Nitroprusside
    • Device: Suction Cup
    • Device: Goldmann applanation tonometer
    • Device: 1060nm Optical coherence tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
Not Provided
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT01333891
OPHT-151010
Yes
Not Provided
Not Provided
Gerhard Garhofer, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Gerhard Garhöfer, MD, PD Department of Clinical Pharmacology, Medical University of Vienna
Medical University of Vienna
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP