Optic Nerve Head Evaluation Through Multimodal Blood Flow Analysis: a Prospective Observational, Multi-center Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorBarboni

About this trial

OCT-A and eco-colordoppler are technologies which enable optic nerve head (ONH) blood perfusion detection. The aim of the study is to assess ONH vascular and structural components in optic neuropathies with and without ONH edema or pseudo-edema with OCT-A, and analyze ONH blood-flow with eco-colordoppler.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant (or parents/legal representative/tutor for minors) is willing and able to give informed consent for participation in the study

patients affected by acute ONH edema (NAION, papilledema, optic neuritis)

patients affected by acute pseudoedema (LHON)

patients affected by chronic pseudoedema (LHON, ODD)

Disqualifiers

any other ONH disease or neurological /retinal disease impairing the evaluation of the ONH;

evidence of media opacities affecting the quality of the vascular assessment;

patients affected Alzheimer/Parkinson disease will be considered separately

Trial population

Patients aged ≥12 years affected with non-arteritic ischemic optic neuropathy (NAION, eye involved and not involved), normal tension glaucoma (NTG), Leber hereditary optic neuropathy (LHON symptomatic and asymptomatic patients \[carriers\]), anterior neuritis \[papillitis\], papilledema, optic disc drusen (ODD), dominant optic atrophy (DOA) and Wolfram Syndrome (WS)

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 1 trial group
Group A: Patient affected by Optic Neuropathies

Trial outcomes

Primary outcomes

1

Parameters correlated to the development and progression (prognostic biomarkers) of the diseases.

Analysis of data collected in symptomatic and asymptomatic eyes, obtained through OCT-A in order to evaluate the relationship between functional and structural parameters in order to identify parameters correlated to the development and progression of the diseases.

Time frame
24 months

Secondary outcomes

1

To assess and compare different ONH vascular components through OCT-A and eco-colordoppler in order to identify parameters correlated to the diseases.

To detect OCT-A parameters (vessel density, perfusion density), and eco-colordoppler parameters of central retina artery (CRA) and short posterior ciliary artery (SPCA) (systolic and diastolic flow and resistance). in order to evaluate their relationship in each optic neuropathy.

Time frame
24 Months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barboni

Lead sponsor

IRCCS San Raffaele

Sponsor institution

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborator

ASST Fatebenefratelli Sacco

Collaborator

This trial is not recruiting at the moment. You can still explore other options: