Association Between Laser Interferometric Measurement of Fundus Pulsation and Pneumotonometric Measurement of Pulsatile Ocular Blood Flow in Patients With Age-related Macular Degeneration

Not Applicable

Completed

• Conditions: Age-related Macular Degeneration
• Interventions: Procedure: blood flow measurement

• Registration Number: NCT00991666
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-07
• Study First Posted: 2009-10-08
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	blood flow measurement	healthy controls
1	blood flow measurement	AMD Patients

Primary Outcome Measures

Name	Time	Method
Ocular rigidity	10 minutes measurement of ocular rigidity
Fundus pulsation amplitude	10 minutes measurement of FPA
Pulsatile ocular blood flow	10 minutes measurement of pulsatile ocular blood flow

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria