Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N)
Recruiting · NCT07720765 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS San Raffaele
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- for neurological patients:
- 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.
- Age greater than 18 years.
- Signed informed consent to study participation.
- Willingness and ability to undergo all study visits and procedures.
- Inclusion Criteria for healthy controls:
- Absence of neurological disease.
- Age greater than 18 years.
- Signed informed consent to study participation.
- Willingness and ability to undergo all study visits and procedures.
Exclusion criteria
- for neurological patients:
- Refusal to participate or withdrawal of informed consent.
- Known or confirmed ocular pathology identified during examination (ophthalmological evaluation may be requested at the investigators' discretion).
- Inability to understand instructions given by investigators.
- Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.
- 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:
- Refusal to participate or withdrawal of informed consent.
- Known or confirmed ocular pathology identified during examination.
- Inability to understand instructions given by investigators.
- Presence of any condition that, in the investigators' opinion, renders the subject unsuitable for the study.
Where it is running
4 locations listed.
- IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit - Milan, Milano, Italy
- IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit - Milan, Milano, Italy
- IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit - Milan, Milano, Italy
- IRCCS Ospedale San Raffaele - Neurology and Neurophysiology Unit - Milan, Milano, Italy