NCT03398616

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 29, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

9 months

First QC Date

January 8, 2018

Last Update Submit

August 19, 2019

Conditions

Keywords

Retinal Bloodflow Pressure

Outcome Measures

Primary Outcomes (1)

  • Retinal pressure-flow-relationship as assessed with FDOCT

    01.02.2018-31.12.2018

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

16 healthy subjects

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, A-1090, Austria

Location

Related Publications (1)

  • Puchner S, Schmidl D, Ginner L, Augustin M, Leitgeb R, Szegedi S, Stjepanek K, Hommer N, Kallab M, Werkmeister RM, Schmetterer L, Garhofer G. Changes in Retinal Blood Flow in Response to an Experimental Increase in IOP in Healthy Participants as Assessed With Doppler Optical Coherence Tomography. Invest Ophthalmol Vis Sci. 2020 Feb 7;61(2):33. doi: 10.1167/iovs.61.2.33.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc.Prof.PD, MD

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 12, 2018

Study Start

March 29, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 20, 2019

Record last verified: 2019-08

Locations