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

NCT07075887 | Not Yet Recruiting

• 1 other identifier: FlowONH
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuro-Ophthalmology; Optic Neuropathies; Optic Atrophy, Hereditary, Leber; Optic Neuropathy, Anterior Ischemic; Optic Disc Drusen; Normal Tension Glaucoma (NTG)

Keywords

oct-a; ecocolordoppler; optic neuropathies

Outcome Measures

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.

  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.

  24 Months

Study Arms (1)

Patient affected by Optic Neuropathies

patients affected by acute ONH edema (NAION, papilledema, optic neuritis) patients affected by acute pseudoedema (LHON) patients affected by chronic pseudoedema (LHON, ODD) patients affected by chronic ONH neuropathies (NTG, DOA, WS) non-affected eyes in each optic neuropathy patient

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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)

You may qualify if:

• 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)
• patients affected by chronic ONH neuropathies (NTG, DOA, WS) non- affected eyes in each optic neuropathy patient

You may not qualify if:

• 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

Sponsors & Collaborators

• Barboni: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• ASST Fatebenefratelli Sacco: collaborator

MeSH Terms

Conditions

Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber; Optic Neuropathy, Ischemic; Optic Disk Drusen; Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Optic Atrophies, Hereditary; Optic Atrophy; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mitochondrial Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases; Glaucoma; Ocular Hypertension

Study Officials

• Piero barboni, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piero Barboni, MD

CONTACT

+39 3935021232; barboni.piero@hsr.it

Marco Battista, MD

CONTACT

+39 3780646254; battista.marco@hsr.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share