Blood Flow Regulation in Glaucoma

August 31, 2021 updated by: Gerhard Garhofer, Medical University of Vienna

Glaucoma is one of the leading causes for blindness in industrialized countries. It is characterized by a progressive loss of retinal ganglion cells, morphological changes in the optic nerve head and a characteristic loss of visual field. Although increased intraocular pressure has been identified as the major risk factor for the development and the progression of the disease it has been speculated for a long time that impaired ocular blood flow may contribute to the pathogenesis of the disease. This concept has been supported by several epidemiological studies showing that low ocular perfusion pressure and small retinal vessel caliber are associated with the disease.

The proposed study tests the hypothesis that patients with glaucoma have reduced total retinal blood flow as compared to healthy subjects. Additionally, autoregulation of blood flow will be investigated during an increase in ocular perfusion pressure. This is of importance because it may clarify the degree of vascular involvement in glaucoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

60 open angle glaucoma patients 60 healthy age- and sex matched controls

Description

Inclusion Criteria:

Patients with open angle glaucoma:

- Diagnosis of manifest open angle glaucoma as defined as pathological optic disc appearance, glaucoma hemifield test outside normal limits and/or untreated intraocular pressure ≥ 21 mmHg on at least three measurements in the medical history. Mean deviation in the visual field test < 10 decibel

Healthy control subjects:

  • normal ophthalmic findings and intraocular pressure < 20 mmHg on at least three measurements
  • no evidence of increased intraocular pressure in the medical history
  • no signs of glaucomatous damage in the optic disc or the glaucoma hemifield test

Exclusion Criteria:

  • Presence or history of a severe medical condition as judged by the investigator
  • Abuse of alcoholic beverages
  • Participation in a clinical trial in the 3 weeks preceding the study
  • Exfoliation glaucoma
  • Pigmentary glaucoma
  • Secondary glaucoma
  • Ocular hypertension
  • History of acute angle closure
  • Intraocular surgery within the last 6 months
  • History of epilepsia
  • Diabetes mellitus
  • Ocular inflammation or infection within the last 3 months
  • Untreated hypertension with systolic blood pressure >160 mmHg, diastolic blood pressure >95 mmHg
  • Pregnancy or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Glaucoma Patients
Patients with primary open angle glaucoma
Other: Isometric exercise
Healthy controls
age- and sex matched controls
Other: Isometric exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Optic nerve head blood flow
Time Frame: once
once

Secondary Outcome Measures

Outcome Measure
Time Frame
Retinal blood flow
Time Frame: once
once

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

November 28, 2016

Study Completion (Actual)

November 28, 2016

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

November 12, 2014

First Posted (Estimate)

November 17, 2014

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-250313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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