Blood Flow Regulation in Glaucoma

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT02292381
Collaborator
(none)
120
1
31.9
3.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Isometric exercise

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Actual Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Nov 28, 2016
Actual Study Completion Date :
Nov 28, 2016

Arms and Interventions

Arm Intervention/Treatment
Glaucoma Patients

Patients with primary open angle glaucoma

Other: Isometric exercise

Healthy controls

age- and sex matched controls

Other: Isometric exercise

Outcome Measures

Primary Outcome Measures

  1. Optic nerve head blood flow [once]

Secondary Outcome Measures

  1. Retinal blood flow [once]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gerhard Garhofer, Assoc. Prof. Univ. Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02292381
Other Study ID Numbers:
  • OPHT-250313
First Posted:
Nov 17, 2014
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2021