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OpenTrials
Completed

NCT Number: NCT03401892

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic Vessel Analyzer (DVA)

Device

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

Fourier Domain Doppler Optical Coherence Tomography (FDOCT)

Device

Retinal blood flow will be assessed using FDOCT.

Optical coherence tomography (OCT)

Device

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

Primary outcomes

  1. Flicker light induced hyperemia in retinal vessels

    Time frame: 1 day

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

Secondary outcomes

  1. Retinal vessel diameters

    Time frame: 1 day

    Response of retinal vessel diameters to flicker light assessed with DVA

  2. Retinal oxygen saturation

    Time frame: 1 day

    Retinal oxygen saturation measured with DVA

  3. Retinal blood flow

    Time frame: 1 day

    Response of retinal blood flow to flicker light assessed with FDOCT

  4. Retinal nerve fiber layer thickness

    Time frame: 1 day

    Retinal nerve fiber layer thickness measured using OCT

  5. Central retinal thickness

    Time frame: 1 day

    Central retinal thickness using OCT

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 17, 2018
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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