Blood Flow Regulation in Glaucoma

Completed

• Conditions: Glaucoma
• Interventions: Other: Isometric exercise

• Registration Number: NCT02292381
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-22
• Study Start: 2014-04
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-17
• Primary Completion: 2016-11-28
• Study Completion: 2016-11-28
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glaucoma Patients	Isometric exercise	Patients with primary open angle glaucoma
Healthy controls	Isometric exercise	age- and sex matched controls

Primary Outcome Measures

Name	Time	Method
Optic nerve head blood flow	once

Secondary Outcome Measures

Name	Time	Method
Retinal blood flow	once

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria