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.

Study Overview

• Status: Completed
• Conditions: Anterior Ischemic Optic Neuropathy
• Intervention / Treatment: Device: Dynamic Vessel Analyzer (DVA); Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Optical coherence tomography (OCT)

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); Retinal vessel diameters and oxygen saturation will be measured with the DVA device.; Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Retinal blood flow will be assessed using FDOCT.; Device: Optical coherence tomography (OCT); Nerve fiber layer thickness and central retinal thickness will be measured using OCT.
EXPERIMENTAL: Healthy control subjects; healthy age-and sex- matched control subjects	Device: Dynamic Vessel Analyzer (DVA); Retinal vessel diameters and oxygen saturation will be measured with the DVA device.; Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Retinal blood flow will be assessed using FDOCT.; Device: Optical coherence tomography (OCT); Nerve fiber layer thickness and central retinal thickness will be measured using OCT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Flicker light induced hyperemia in retinal vessels	Response of retinal vessels to increased neuronal activity assessed with flicker light	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal vessel diameters	Response of retinal vessel diameters to flicker light assessed with DVA	1 day
Retinal oxygen saturation	Retinal oxygen saturation measured with DVA	1 day
Retinal nerve fiber layer thickness	Retinal nerve fiber layer thickness measured using OCT	1 day
Retinal blood flow	Response of retinal blood flow to flicker light assessed with FDOCT	1 day
Central retinal thickness	Central retinal thickness using OCT	1 day

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2018
• Primary Completion (ACTUAL): June 11, 2018
• Study Completion (ACTUAL): June 11, 2018

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (ACTUAL): January 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ischemia; Optic Nerve Diseases; Optic Neuropathy, Ischemic
• Other Study ID Numbers: OPHT-210917

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No