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

Anterior Ischemic Optic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03401892
• Other study ID #: OPHT-210917
• Status: Completed
• Phase: N/A
• Start date: June 11, 2018
• Est. completion date: June 11, 2018

Study information

• Verified date: August 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 11, 2018
• Est. primary completion date: June 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Ischemic Optic Neuropathy
• Ischemia
• Optic Nerve Diseases
• Optic Neuropathy, Ischemic

Intervention

Device:
• Dynamic Vessel Analyzer (DVA)
Retinal vessel diameters and oxygen saturation will be measured with the DVA device.
• Fourier Domain Doppler Optical Coherence Tomography (FDOCT)
Retinal blood flow will be assessed using FDOCT.
• Optical coherence tomography (OCT)
Nerve fiber layer thickness and central retinal thickness will be measured using OCT.

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flicker light induced hyperemia in retinal vessels	Response of retinal vessels to increased neuronal activity assessed with flicker light	1 day
Secondary	Retinal vessel diameters	Response of retinal vessel diameters to flicker light assessed with DVA	1 day
Secondary	Retinal oxygen saturation	Retinal oxygen saturation measured with DVA	1 day
Secondary	Retinal blood flow	Response of retinal blood flow to flicker light assessed with FDOCT	1 day
Secondary	Retinal nerve fiber layer thickness	Retinal nerve fiber layer thickness measured using OCT	1 day
Secondary	Central retinal thickness	Central retinal thickness using OCT	1 day