Back to results

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

Primary Purpose

Anterior Ischemic Optic Neuropathy

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Dynamic Vessel Analyzer (DVA)

Fourier Domain Doppler Optical Coherence Tomography (FDOCT)

Optical coherence tomography (OCT)

About this trial

This is an interventional basic science trial for Anterior Ischemic Optic Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Clinical Pharmacology, Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients with a history of NAION

Healthy control subjects

Arm Description

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

healthy age-and sex- matched control subjects

Outcomes

Primary Outcome Measures

Flicker light induced hyperemia in retinal vessels

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

Secondary Outcome Measures

Retinal vessel diameters

Response of retinal vessel diameters to flicker light assessed with DVA

Retinal oxygen saturation

Retinal oxygen saturation measured with DVA

Retinal blood flow

Response of retinal blood flow to flicker light assessed with FDOCT

Retinal nerve fiber layer thickness

Retinal nerve fiber layer thickness measured using OCT

Central retinal thickness

Central retinal thickness using OCT

Full Information

NCT ID

NCT03401892

First Posted

January 10, 2018

Last Updated

August 31, 2021

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT03401892

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

June 11, 2018 (Actual)

Primary Completion Date

June 11, 2018 (Actual)

Study Completion Date

June 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Ischemic Optic Neuropathy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with a history of NAION

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy control subjects

Arm Type

Experimental

Arm Description

healthy age-and sex- matched control subjects

Intervention Type

Device

Intervention Name(s)

Dynamic Vessel Analyzer (DVA)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Fourier Domain Doppler Optical Coherence Tomography (FDOCT)

Intervention Description

Retinal blood flow will be assessed using FDOCT.

Intervention Type

Device

Intervention Name(s)

Optical coherence tomography (OCT)

Intervention Description

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

Primary Outcome Measure Information:

Title

Flicker light induced hyperemia in retinal vessels

Description

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

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Retinal vessel diameters

Description

Response of retinal vessel diameters to flicker light assessed with DVA

Time Frame

1 day

Title

Retinal oxygen saturation

Description

Retinal oxygen saturation measured with DVA

Time Frame

1 day

Title

Retinal blood flow

Description

Response of retinal blood flow to flicker light assessed with FDOCT

Time Frame

1 day

Title

Retinal nerve fiber layer thickness

Description

Retinal nerve fiber layer thickness measured using OCT

Time Frame

1 day

Title

Central retinal thickness

Description

Central retinal thickness using OCT

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerhard Garhöfer, MD

Organizational Affiliation

Department of Clinical Pharmacology, Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Clinical Pharmacology, Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs