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OpenTrials
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NCT Number: NCT02292381

Blood Flow Regulation in Glaucoma

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isometric exercise

Other

Primary outcomes

  1. Optic nerve head blood flow

    Time frame: once

Secondary outcomes

  1. Retinal blood flow

    Time frame: once

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2014
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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