OCT in Neurological Practice: Use of Retinal Layers to Help Diagnose and Follow Neurological Diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, observational cohort study conducted at a single center in Milan, enrolling adults with CNS neurological diseases and age-matched healthy controls. Participants undergo standardized OCT scans at baseline and every 6 months for two years, with measurements of retinal layers such as RNFL, GCL, and IPL. The study will correlate OCT-derived retinal measures with clinical scales, neuroimaging findings, and routine biomarkers to explore the utility of OCT in diagnostic workups and longitudinal monitoring. The Heidelberg SPECTRALIS HRA+OCT device is used, and inclusion criteria require confirmed CNS disease or absence of neurological disease and informed consent.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit
  Milan, Milano, Italy Recruiting

Study contacts

• Principal investigator: Massimo Filippi, Prof, MD — IRCCS San Raffaele
• Study coordinator: Federica Agosta, MD
• Email: agosta.federica@hsr.it
• Phone: 0226433051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.