Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow

Not Applicable

Withdrawn

• Conditions: Open Angle Glaucoma

• Registration Number: NCT00912470
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry).	up to 6 years.

Trial Locations

Locations (1)

Department of Clinical Pharmacology; 🇦🇹 Vienna, Austria