NCT03401892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

June 11, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2018

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

Same day

First QC Date

January 10, 2018

Last Update Submit

August 31, 2021

Conditions

Anterior Ischemic Optic Neuropathy

Outcome Measures

Primary Outcomes (1)

  • Flicker light induced hyperemia in retinal vessels

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

    1 day

Secondary Outcomes (5)

  • Retinal vessel diameters

    1 day

  • Retinal oxygen saturation

    1 day

  • Retinal blood flow

    1 day

  • Retinal nerve fiber layer thickness

    1 day

  • Central retinal thickness

    1 day

Study Arms (2)

Patients with a history of NAION

EXPERIMENTAL

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

Device: Dynamic Vessel Analyzer (DVA)Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT)Device: Optical coherence tomography (OCT)

Healthy control subjects

EXPERIMENTAL

healthy age-and sex- matched control subjects

Device: Dynamic Vessel Analyzer (DVA)Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT)Device: Optical coherence tomography (OCT)

Interventions

Dynamic Vessel Analyzer (DVA)DEVICE

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

Healthy control subjectsPatients with a history of NAION
Fourier Domain Doppler Optical Coherence Tomography (FDOCT)DEVICE

Retinal blood flow will be assessed using FDOCT.

Healthy control subjectsPatients with a history of NAION
Optical coherence tomography (OCT)DEVICE

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

Healthy control subjectsPatients with a history of NAION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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
  • 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Gerhard Garhöfer, MD

    Department of Clinical Pharmacology, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section Head Ophthalmo-Pharmacology

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 17, 2018

Study Start

June 11, 2018

Primary Completion

June 11, 2018

Study Completion

June 11, 2018

Last Updated

September 1, 2021

Record last verified: 2021-08

Locations

AU(1)