Blood Flow Regulation in Glaucoma

NCT02292381 | Completed

• 1 other identifier: OPHT-250313
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Optic nerve head blood flow

  once

Secondary Outcomes (1)

• Retinal blood flow

  once

Study Arms (2)

Glaucoma Patients

Patients with primary open angle glaucoma

Other: Isometric exercise

Healthy controls

age- and sex matched controls

Other: Isometric exercise

Interventions

Isometric exercise OTHER

Glaucoma Patients; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Univ. Doz. Dr.

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: November 17, 2014
• Study Start: April 1, 2014
• Primary Completion: November 28, 2016
• Study Completion: November 28, 2016
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

AU (1)