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Association Between Laser Interferometric Measurement of Fundus Pulsation and Pneumotonometric Measurement of Pulsatile Ocular Blood Flow in Patients With Age-related Macular Degeneration

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00991666
First received: October 7, 2009
Last updated: December 1, 2010
Last verified: November 2010
History of Changes
  Purpose

Several methods have been proposed for the measurement of pulsatile ocular blood flow (POBF). The pneumatic tonometer, which is commercially available, assesses POBF by measurement of intraocular pressure (IOP) changes during the cardiac cycle. The investigators have recently developed a method for the measurement of ocular fundus pulsation, which is based on laser interferometry. In contrast to the Langham system the method is non-contractile and yields a high topographic resolution. Moreover, the pneumatic tonometer assesses the ocular pressure pulse, whereas ocular fundus pulsation is a point measure of the ocular volume pulse. These two parameters are related by the ocular rigidity, which refers to the mechanical properties of the eye coats.

Age-related macular degeneration (AMD) is the most common cause of blindness in the industrialized nations. The mechanisms behind this severe eye disease are, however, still obscure. It has been hypothesized that alterations in choroidal blood flow and ocular rigidity may contribute to the development and progression of AMD. However, there is currently little data to confirm this hypothesis. The present study is an attempt to investigate choroidal blood flow and ocular rigidity by employing laser interferometric measurement of fundus pulsation and pneumotonometric measurement of fundus pulsation.


Condition Intervention
Age-Related Macular Degeneration
 Procedure: blood flow measurement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Association Between Laser Interferometric Measurement of Fundus Pulsation and Pneumotonometric Measurement of Pulsatile Ocular Blood Flow in Patients With Age-related Macular Degeneration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Fundus pulsation amplitude [ Time Frame: 10 minutes measurement of FPA ] [ Designated as safety issue: No ]
  • Pulsatile ocular blood flow [ Time Frame: 10 minutes measurement of pulsatile ocular blood flow ] [ Designated as safety issue: No ]
  • Ocular rigidity [ Time Frame: 10 minutes measurement of ocular rigidity ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: July 2001
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AMD Patients
 Procedure: blood flow measurement
Fundus pulsation amplitude measurement Pulsatile ocular blood flow measurement
Active Comparator: 2
healthy controls
 Procedure: blood flow measurement
Fundus pulsation amplitude measurement Pulsatile ocular blood flow measurement

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with AMD (defined as soft drusen > 63 µm, hyperpigmentation and/or hypopigmentation of the retinal pigment epithelium (RPE), RPE and associated neurosensory detachment, (peri)retinal hemorrhages, geographic atrophy of the RPE, or (peri)retinal fibrous scarring)
  • Age between 50 and 90 years

Exclusion Criteria:

  • Evidence of any other retinal or choroidal vascular disease
  • Regular use of pentoxifylline in the last month before the trial period
  • Evidence of a choroidal neovascular membrane
  • Diabetes mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991666

Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria
Contact: Gerhard Garhöfer, MD     +431404002981        
Sub-Investigator: Karl Kircher, MD            
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Leopold Schmetterer, Prof. Dr. Department of Clinical Pharmacology, Medical University of Vienna
  More Information

No publications provided

Responsible Party: Gabriele Fuchsjaeger-Mayrl, MD, Department of Clinical Pharmacology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00991666     History of Changes
Other Study ID Numbers: OPHT-200401
Study First Received: October 7, 2009
Last Updated: December 1, 2010
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
AMD
rigidity
pulsatile ocular blood flow
Physiology of the eye

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013