NCT00912470

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

7.5 years

First QC Date

June 2, 2009

Last Update Submit

November 20, 2014

Conditions

Open Angle Glaucoma

Keywords

genetic vascular risc factorsocular blood flowprogressive glaucoma

Outcome Measures

Primary Outcomes (1)

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

    up to 6 years.

Interventions

ocular blood flow measurementPROCEDURE

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

Also known as: Blood sample for Frequency distribution of alleles

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Gerhard Garhöfer, MD

    Department of Clinical Pharmacology, Medical University of Vienna

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 3, 2009

Study Start

May 1, 2007

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 21, 2014

Record last verified: 2014-11

Locations

AU(1)