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Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow

Primary Purpose

Open Angle Glaucoma

Status

Withdrawn

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

ocular blood flow measurement

About this trial

This is an interventional diagnostic trial for Open Angle Glaucoma focused on measuring genetic vascular risc factors, ocular blood flow, progressive glaucoma

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Clinical Pharmacology

Outcomes

Primary Outcome Measures

Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry).

Secondary Outcome Measures

Full Information

NCT ID

NCT00912470

First Posted

June 2, 2009

Last Updated

November 20, 2014

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT00912470

Brief Title

Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow

Official Title

Genetic Vascular Risk Factors and Ocular Blood Flow in Patients With Progressive Open Angle Glaucoma (OAG)-a Longitudinal Prospective Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Withdrawn

Study Start Date

May 2007 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Angle Glaucoma

Keywords

genetic vascular risc factors, ocular blood flow, progressive glaucoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

ocular blood flow measurement

Other Intervention Name(s)

Blood sample for Frequency distribution of alleles

Intervention Description

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

Primary Outcome Measure Information:

Title

Optic nerve head blood flow (scanning laser Doppler flowmetry, laser Doppler flowmetry).

Time Frame

up to 6 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Garhöfer, MD

Organizational Affiliation

Department of Clinical Pharmacology, Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

Progressive Open Angle Glaucoma (OAG) and Ocular Blood Flow

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