Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Optical Coherence Tomography (OCT) - Heidelberg SPECTRALIS HRA+OCT
Treatment groups
1,050 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov