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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

Primary Purpose

Age-related Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
blood flow measurement
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Age-related Macular Degeneration focused on measuring AMD, rigidity, pulsatile ocular blood flow, Physiology of the eye

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

AMD Patients

healthy controls

Outcomes

Primary Outcome Measures

Fundus pulsation amplitude
Pulsatile ocular blood flow
Ocular rigidity

Secondary Outcome Measures

Full Information

First Posted
October 7, 2009
Last Updated
November 13, 2014
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00991666
Brief Title
Association Between Laser Interferometric Measurement of Fundus Pulsation and Pneumotonometric Measurement of Pulsatile Ocular Blood Flow in Patients With Age-related Macular Degeneration
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
AMD, rigidity, pulsatile ocular blood flow, Physiology of the eye

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
AMD Patients
Arm Title
2
Arm Type
Active Comparator
Arm Description
healthy controls
Intervention Type
Procedure
Intervention Name(s)
blood flow measurement
Intervention Description
Fundus pulsation amplitude measurement Pulsatile ocular blood flow measurement
Primary Outcome Measure Information:
Title
Fundus pulsation amplitude
Time Frame
10 minutes measurement of FPA
Title
Pulsatile ocular blood flow
Time Frame
10 minutes measurement of pulsatile ocular blood flow
Title
Ocular rigidity
Time Frame
10 minutes measurement of ocular rigidity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leopold Schmetterer, Prof. Dr.
Organizational Affiliation
Department of Clinical Pharmacology, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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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