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CompletedNCT03401892Updated Sep 1, 2021

Retinal Neuro-vascular Coupling in Patients With Non-arteritic Anterior Ischemic Optic Neuropathy

An interventional study of Dynamic Vessel Analyzer (DVA) and Fourier Domain Doppler Optical Coherence Tomography (FDOCT) in Anterior Ischemic Optic Neuropathy, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-01.

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

Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Ischemic optic neuropathy is among the most common causes of serious impaired vision in the middle-aged and elderly population in the western world. The current study focuses on a subgroup of ischemic optic neuropathy, the so-called non-arteritic ischemic optic neuropathy (NAION). Although the exact pathogenesis of NAION has not been fully clarified it is known that patients with cardio-vascular risk factors such as hypertension, diabetes mellitus and dyslipidemia have also an increased risk to develop NAION. Along this line of thought it has been shown that patients with a history of NAION in one eye have an increased risk to develop NAION also on the contralateral eye. However, clinical studies investigating ocular perfusion abnormalities in patients with NAION are sparse and even contradicting. Thus, the current study seeks to measure ocular blood flow parameters in patients with a history of NAION and compare it to healthy age-matched subjects.

02

Conditions studied

  • Anterior Ischemic Optic Neuropathy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion criteria for healthy subjects:

  • Men and women aged over 18 years
  • Non-smokers
  • Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
  • Normal ophthalmic findings, ametropy \< 6 Dpt.

Inclusion criteria for patients with NAION:

  • Men and women aged over 18 years
  • History of NAION in one eye
  • Normal ophthalmic findings, ametropy \< 6 Dpt.
  • Adequate visual acuity to allow participation in the ocular blood flow measurements
  • A potential participant has to be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history for at least 30 days prior inclusion, if considered relevant by the investigator.

Any of the following will exclude a healthy subject from the study:

  • Current ocular disease or history of NAION
  • Presence or history of a severe medical condition as judged by the clinical investigator
  • Untreated Arterial hypertension
  • History or family history of epilepsy
  • Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
  • Best corrected visual acuity \< 0.5 Snellen
  • Ametropy ≥ 6 Dpt
  • Pregnancy or planned pregnancy
  • Alcoholism or substance abuse

Any of the following will exclude a patient from the study:

  • Presence or history of a severe medical condition other NAION as judged by the clinical investigator
  • Untreated Arterial hypertension
  • History or family history of epilepsy
  • Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator
  • Best corrected visual acuity \< 0.5 Snellen in the non-affected eye
  • Ametropy ≥ 6 Dpt
  • Pregnancy, planned pregnancy
  • Alcoholism or substance abuse
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    Patients with a history of NAION

    patients with a history of non-arteritic anterior ischemic optic neuropathy (NAION) in one eye

    Device: Dynamic Vessel Analyzer (DVA) · Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT) · Device: Optical coherence tomography (OCT)

  • Experimental
    Healthy control subjects

    healthy age-and sex- matched control subjects

    Device: Dynamic Vessel Analyzer (DVA) · Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT) · Device: Optical coherence tomography (OCT)

Interventions

  • DeviceDynamic Vessel Analyzer (DVA)

    Retinal vessel diameters and oxygen saturation will be measured with the DVA device.

  • DeviceFourier Domain Doppler Optical Coherence Tomography (FDOCT)

    Retinal blood flow will be assessed using FDOCT.

  • DeviceOptical coherence tomography (OCT)

    Nerve fiber layer thickness and central retinal thickness will be measured using OCT.

05

What researchers measure

Primary outcomes

  1. Flicker light induced hyperemia in retinal vessels

    Response of retinal vessels to increased neuronal activity assessed with flicker light

    Time frame: 1 day

Secondary outcomes

  1. Retinal vessel diameters

    Response of retinal vessel diameters to flicker light assessed with DVA

    Time frame: 1 day

  2. Retinal oxygen saturation

    Retinal oxygen saturation measured with DVA

    Time frame: 1 day

  3. Retinal blood flow

    Response of retinal blood flow to flicker light assessed with FDOCT

    Time frame: 1 day

  4. Retinal nerve fiber layer thickness

    Retinal nerve fiber layer thickness measured using OCT

    Time frame: 1 day

  5. Central retinal thickness

    Central retinal thickness using OCT

    Time frame: 1 day

06

Study locations

1 site
  • Department of Clinical Pharmacology, Medical University of Vienna
    Vienna, 1090, Austria
07

Registry details

Key details

Study ID
NCT03401892
Lead sponsor
Medical University of Vienna
Responsible party
Gerhard Garhofer (Section Head Ophthalmo-Pharmacology, Medical University of Vienna) — Principal investigator
First posted
Jan 17, 2018
Start date
Jun 11, 2018
Primary completion
Jun 11, 2018
Completion
Jun 11, 2018
Last update
Sep 1, 2021

Study contacts

Gerhard Garhöfer, MD
principal investigator · Department of Clinical Pharmacology, Medical University of Vienna

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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