Clinical trial NCT00991666: 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
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Keywords: AMD
rigidity
pulsatile ocular blood flow
Physiology of the eye
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Fundus pulsation amplitude
timeFrame: 10 minutes measurement of FPA
measure: Pulsatile ocular blood flow
timeFrame: 10 minutes measurement of pulsatile ocular blood flow
measure: Ocular rigidity
timeFrame: 10 minutes measurement of ocular rigidity
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Department of Clinical Pharmacology, Medical University of Vienna
name: Leopold Schmetterer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: