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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

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ClinicalTrials.gov Identifier: NCT00991666
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Age-related Macular Degeneration Procedure: blood flow measurement

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2001
Primary Completion Date : February 2011
Study Completion Date : March 2011

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Fundus pulsation amplitude [ Time Frame: 10 minutes measurement of FPA ]
  2. Pulsatile ocular blood flow [ Time Frame: 10 minutes measurement of pulsatile ocular blood flow ]
  3. Ocular rigidity [ Time Frame: 10 minutes measurement of ocular rigidity ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991666


Locations
Austria
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Leopold Schmetterer, Prof. Dr. Department of Clinical Pharmacology, Medical University of Vienna
More Information

Responsible Party: Gerhard Garhofer, Assoc. Prof. Priv. - Doz. Dr, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00991666     History of Changes
Other Study ID Numbers: OPHT-200401
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: November 2014

Keywords provided by Gerhard Garhofer, 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