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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03398616
Other study ID # OPHT-080515
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 29, 2018
Est. completion date December 31, 2018

Study information

Verified date August 2019
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. Large scale studies have shown that reduced ocular perfusion pressure is an important risk factor for the prevalence, the incidence and the progression of primary open angle glaucoma. There is also evidence that autoregulation is impaired in patients with primary open angle glaucoma.

To gain more insight into these phenomena in humans is the primary goal of the present study.

The present study aims to investigate the pressure/flow relationship as a measure for retinal blood flow autoregulation during an experimental increase in intraocular pressure by the use of the suction cup technique. Retinal blood flow will be measured by Doppler OCT.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Men and women aged between 18 and 35 years

- Non-smokers

- Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant

- Normal ophthalmic findings, ametropy < 1 Dpt.

Exclusion Criteria:- Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study

- Treatment in the previous 3 weeks with any drug (except contraceptives)

- Symptoms of a clinically relevant illness in the 3 weeks before the first study day

- Blood donation during the previous 3 weeks

- Pregnancy, planned pregnancy or lactating

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Department of Clinical Pharmacology, Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Gerhard Garhofer

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retinal pressure-flow-relationship as assessed with FDOCT 01.02.2018-31.12.2018