Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2014-11-30

Brief Summary

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The purpose of this study is to assess the correlation of vascular parameters, including genetic factors as well as ocular blood flow parameters against the progression rate of glaucomatous damage in patients with progressive OAG.

Detailed Description

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Glaucoma is one of the most common causes of blindness in the industrialized nations. For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disc damage and subsequent visual field loss. However, recent investigations show that IOP is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. The role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. Genes with products that are involved in the regulation of blood flow to ocular tissues may also be considered plausible candidates as a contributory factor in the development of glaucoma. Little is, however, known about a potential association between glaucomatous optic neuropathy and glaucomatous visual field defects and optic nerve head blood flow in patients with progressive open angle glaucoma (OAG). The current study seeks to gain insight into this association by assessing ocular blood flow parameters with a number of noninvasive technologies.

Conditions

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Open Angle Glaucoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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ocular blood flow measurement

Retinal blood flow (with scanning laser Doppler flowmetry, laser Doppler velocimetry + retinal vessel analyzer) each measurement once on the study eye

Choroidal blood flow (with laser Doppler flowmetry, laser interferometry, pneumotonometry)

Frequency distribution of alleles of genetic markers for NOS3, more precisely eNOS -786CC polymorphism and of ET-1 (EDN1), and the receptors ETA (EDNRA), more precisely EDN1/+138/ex1 del/ins, EDN1/K198N, EDNRA/C+1222T, EDNRA/C+70G polymorphisms

Intervention Type PROCEDURE

Other Intervention Names

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Blood sample for Frequency distribution of alleles

Eligibility Criteria

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Inclusion Criteria

* Men and women over 40 years
* Unilateral or bilateral primary open angle glaucoma (POAG) or normal tension glaucoma (NTG) with visual defect, marked by an AGIS score (1994; 1. Study design and methods and baseline characteristics of study patient) of at least 1 but not more than 16 at the screening visit
* At least 3 reliable visual field tests in the eye that will be studied
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Best-corrected visual acuity of 20/40 or better, spherical refraction within ± 3.0 diopters and cylinder correction within ± 3.0 diopters

Exclusion Criteria

* Evidence of secondary glaucoma, pseudoexfoliation, pigmentary dispersion
* Any form of retinal or neuroophthalmological disease that could result in visual field defects.
* Mean IOP \> 30 mmHg, or any IOP \> 35 mmHg in at least one eye
* History of acute angle closure
* Closed or barely open anterior chamber angle
* Topical or systemical/oral therapy with steroids
* Standard deviation of visual field testing \> 10
* Ocular inflammation or infection within the last three months
* Intraocular surgery or argon laser trabeculoplasty within the last six months
* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* Ametropia \> 3 dpt

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Medical university of Vienna

Principal Investigators

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Gerhard Garhöfer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacology, Medical University of Vienna

Locations

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Department of Clinical Pharmacology

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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OPHT-020706

Identifier Type: -

Identifier Source: org_study_id