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Clinical Trials in Italy / NCT07720765
Recruiting Observational

Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N)

NCT07720765 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2023-10-09
Last updated
2026-07-22

Condition(s) studied

Multiple SclerosisAlzheimer DiseaseParkinson DiseaseMigraineHeadache Disorders

Investigational drug(s) / intervention(s)

Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT

Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT: Spectral-domain Optical Coherence Tomography (OCT) performed using the Heidelberg SPECTRALIS HRA+OCT device (Class IIa CE-marked medical device). The procedure is non-invasive: the patient sits in front of the device and is asked to fix a target (light or cross) through a lens. No drugs or contrast agents are administered. OCT automatically acquires images of the macular region (where GCL and IPL are most represented) and the optic nerve head region (where RNFL is most represented), providing automated measurements of the thickness of individual retinal layers. OCT is performed at baseline and at follow-up visits at 6, 12, 18, and/or 24 months. Ophthalmological evaluation may be performed at the investigators' discretion if OCT images, clinical symptoms, or medical history suggest concurrent ocular pathology. Patients with a known diagnosis of epilepsy or history of epileptic seizures will not undergo specific imaging modes using clearly visible light sources (MultiColor, FA, BAF).

Study summary

OCt.IN.N is a national, monocentric, prospective, observational cohort study evaluating the utility and applicability of Optical Coherence Tomography (OCT) in the diagnostic workup and longitudinal monitoring of neurological diseases.

840 patients with Central Nervous System neurological diseases (Multiple Sclerosis, Alzheimer's disease, Parkinson's disease, migraine/headache) and 210 age-matched healthy controls will undergo OCT examination at baseline and at 6, 12, 18, and 24 months of follow-up at IRCCS San Raffaele Hospital, Milan, Italy.

OCT is a non-invasive, rapid, and reproducible technique that automatically measures the thickness of individual retinal layers. Retinal layer thicknesses and their longitudinal changes will be correlated with established clinical scales, neuroimaging, and biological markers used in routine neurological practice.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria for neurological patients: 1. Diagnosis of a Central Nervous System neurological disease (inflammatory diseases such as Multiple Sclerosis; neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease; migraine/headache) according to currently accepted diagnostic criteria for each condition. 2. Age greater than 18 years. 3. Signed informed consent to study participation. 4. Willingness and ability to undergo all study visits and procedures. Inclusion Criteria for healthy controls: 1. Absence of neurological disease. 2. Age greater than 18 years. 3. Signed informed consent to study participation. 4. Willingness and ability to undergo all study visits and procedures. Exclusion Criteria for neurological patients: 1. Refusal to participate or withdrawal of informed consent. 2. Known or confirmed ocular pathology identified during examination (ophthalmological evaluation may be requested at the investigators' discretion). 3. Inability to understand instructions given by investigators. 4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study. 5. For specific imaging modes using clearly visible light sources (MultiColor, FA, BAF): diagnosis of epilepsy or history of previous epileptic seizures. Exclusion Criteria for healthy controls: 1. Refusal to participate or withdrawal of informed consent. 2. Known or confirmed ocular pathology identified during examination. 3. Inability to understand instructions given by investigators. 4. Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.

Primary outcome measure(s)

  • Annual rate of peripapillary RNFL thinning in patients with Multiple Sclerosis vs healthy controls — Baseline, 6, 12, 18, and 24 months
    Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls.
  • Annual rate of peripapillary RNFL thinning in patients with Alzheimer's Disease vs healthy controls — Baseline, 6, 12, 18, and 24 months
    Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls.
  • Annual rate of peripapillary RNFL thinning in patients with Parkinson's Disease vs healthy controls — Baseline, 6, 12, 18, and 24 months
    Annualized thinning rate (micrometers per year) of the peripapillary retinal nerve fiber layer (RNFL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls.
  • Annual rate of macular GCL thinning in patients with Multiple Sclerosis disease vs healthy controls — Baseline, 6, 12, 18, and 24 months
    Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls
  • Annual rate of macular GCL thinning in patients with Alzheimer's Disease vs healthy controls — Baseline, 6, 12, 18, and 24 months
    Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls
  • Annual rate of macular GCL thinning in patients with Parkinson's Disease vs healthy controls — Baseline, 6, 12, 18, and 24 months
    Annualized thinning rate (micrometers per year) of the macular ganglion cell layer (GCL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls
  • Annual rate of macular IPL thinning in patients with Multiple Sclerosis vs healthy controls — Baseline, 6, 12, 18, and 24 months
    Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Multiple Sclerosis compared to age-matched healthy controls
  • Annual rate of macular IPL thinning in patients with Alzheimer's Disease vs healthy controls — Baseline, 6, 12, 18, and 24 months
    Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Alzheimer's Disease compared to age-matched healthy controls
  • Annual rate of macular IPL thinning in patients with Parkinson's Disease vs healthy controls — Baseline, 6, 12, 18, and 24 months
    Annualized thinning rate (micrometers per year) of the macular inner plexiform layer (IPL) measured by OCT in patients with Parkinson's Disease compared to age-matched healthy controls

Trial sites (1)

FacilityCityRegionStatus
IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit Milan Milano Recruiting

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Other trials for the same condition

A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis Active, not recruiting
Neuropsychological Profile Characterization in Patients With Migraine: Cognitive Functioning and Psychological Variables Recruiting
Superior Cervical Ganglion in Parkinson's Disease Recruiting
Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis Active, not recruiting
Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07720765 on ClinicalTrials.gov ↗ ← All trials in Italy