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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

NCT ID: NCT00991666

Last Updated: 2014-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age-related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

AMD Patients

Group Type EXPERIMENTAL

blood flow measurement

Intervention Type PROCEDURE

Fundus pulsation amplitude measurement Pulsatile ocular blood flow measurement

2

healthy controls

Group Type ACTIVE_COMPARATOR

blood flow measurement

Intervention Type PROCEDURE

Fundus pulsation amplitude measurement Pulsatile ocular blood flow measurement

Interventions

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blood flow measurement

Fundus pulsation amplitude measurement Pulsatile ocular blood flow measurement

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Garhofer

Assoc. Prof. Priv. - Doz. Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leopold Schmetterer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-200401

Identifier Type: -

Identifier Source: org_study_id