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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03401892
Enrollment
1
Registered
2018-01-17
Start date
2018-06-11
Completion date
2018-06-11
Last updated
2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Ischemic Optic Neuropathy

Brief 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.

Interventions

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

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.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Flicker light induced hyperemia in retinal vessels1 dayResponse of retinal vessels to increased neuronal activity assessed with flicker light

Secondary

MeasureTime frameDescription
Retinal vessel diameters1 dayResponse of retinal vessel diameters to flicker light assessed with DVA
Retinal oxygen saturation1 dayRetinal oxygen saturation measured with DVA
Retinal blood flow1 dayResponse of retinal blood flow to flicker light assessed with FDOCT
Retinal nerve fiber layer thickness1 dayRetinal nerve fiber layer thickness measured using OCT
Central retinal thickness1 dayCentral retinal thickness using OCT

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026