NCT00991666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

Enrollment Period

9.6 years

First QC Date

October 7, 2009

Last Update Submit

November 13, 2014

Conditions

Age-related Macular Degeneration

Keywords

AMDrigiditypulsatile ocular blood flowPhysiology of the eye

Outcome Measures

Primary Outcomes (3)

  • Fundus pulsation amplitude

    10 minutes measurement of FPA

  • Pulsatile ocular blood flow

    10 minutes measurement of pulsatile ocular blood flow

  • Ocular rigidity

    10 minutes measurement of ocular rigidity

Study Arms (2)

1

EXPERIMENTAL

AMD Patients

Procedure: blood flow measurement

2

ACTIVE COMPARATOR

healthy controls

Procedure: blood flow measurement

Interventions

blood flow measurementPROCEDURE

Fundus pulsation amplitude measurement Pulsatile ocular blood flow measurement

12

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Macular DegenerationMuscle Rigidity

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Leopold Schmetterer, Prof. Dr.

    Department of Clinical Pharmacology, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Priv. - Doz. Dr

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

July 1, 2001

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations

AU(1)