CClinicalTrials.gg
TerminatedNCT00914394Updated Nov 14, 2014

Role of Nitric Oxide in Optic Nerve Head Blood Flow Regulation During Experimental Increase of Intraocular Pressure in Healthy Humans

An interventional study of NG-monomethyl-L-arginine (L-NMMA) and Phenylephrine in Healthy, sponsored by Medical University of Vienna. Terminated at 1 site in Austria. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-14.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Former studies that investigated ocular blood flow autoregulation focused mainly on choroidal blood flow. For the optic nerve head only few data are available, although it seems likely that it underlies similar autoregulatory mechanisms.

A previous study investigating choroidal blood flow has shown that nitric oxide (NO) plays a key role in choroidal autoregulation. The present study is designed to test the hypothesis that NO plays a role in optic nerve head autoregulation during increased intraocular pressure (IOP). Therefore, IOP will be experimentally increased using a suction cup device in the absence of presence of either a nitric oxide synthase inhibitor (L-NMMA), an α-receptor agonist (phenylephrine) or placebo. Optic nerve head blood flow will be continuously measured during the procedure.

02

Conditions studied

  • Healthy

Keywords

  • L-NG-Monomethyl Arginine
  • Optic Nerve Head Blood Flow
  • Intraocular Pressure
  • Regional Blood Flow
  • Ocular Physiology
  • Optic Disk
03

In context

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Men and women aged between 18 and 35 years, nonsmokers
  • Men and women will be included in equal parts
  • Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropia less than 1 diopter

Exclusion criteria

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 intake of oral contraceptives)
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
  • Blood donation during the previous 3 weeks
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Active comparator
    NG-monomethyl-L-arginine (L-NMMA)

    Drug: NG-monomethyl-L-arginine (L-NMMA) · Drug: Phenylephrine · Drug: Physiological saline solution (as placebo) · Device: Laser Doppler Flowmetry · Device: Goldmann applanation tonometer · Device: Suction cup

  • Active comparator
    Phenylephrine

    Drug: NG-monomethyl-L-arginine (L-NMMA) · Drug: Phenylephrine · Drug: Physiological saline solution (as placebo) · Device: Laser Doppler Flowmetry · Device: Goldmann applanation tonometer · Device: Suction cup

  • Placebo comparator
    Physiological saline solution

    Drug: NG-monomethyl-L-arginine (L-NMMA) · Drug: Phenylephrine · Drug: Physiological saline solution (as placebo) · Device: Laser Doppler Flowmetry · Device: Goldmann applanation tonometer · Device: Suction cup

Interventions

  • DrugNG-monomethyl-L-arginine (L-NMMA)

    bolus 6mg/kg over 5 minutes followed by a continuous infusion of 60µg/kg/min over 15 minutes

  • DrugPhenylephrine

    1µg/kg/min, infusion period 20 minutes

  • DrugPhysiological saline solution (as placebo)

    infusion period 20 minutes

  • DeviceLaser Doppler Flowmetry

    Measurements will be performed at the neuroretinal rim to assess ONH blood flow.

  • DeviceGoldmann applanation tonometer

    intraocular pressure measurements

  • DeviceSuction cup

    Experimental stepwise increase of intraocular pressure while measurement of optic nerve head blood flow.

06

What researchers measure

Primary outcomes

  1. optic nerve head pressure-flow relationship

    Time frame: 1 year

07

Study locations

1 site
  • Department of Clinical Pharmacology, Medical University of Vienna
    Vienna, 1090, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00914394
Lead sponsor
Medical University of Vienna
Responsible party
Gerhard Garhofer (Assoc Prof Priv-Doz Dr, Medical University of Vienna) — Principal investigator
First posted
Jun 5, 2009
Start date
Oct 2010
Primary completion
Jul 2011
Last update
Nov 14, 2014

Study contacts

Gabriele Fuchsjaeger-Mayrl, MD, Univ.Doz.
principal investigator · Department of Clinical Pharmacology, Medical University of Vienna

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion