Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurologi… (NCT07720765) | Clinical Trial Compass
RecruitingNot Applicable
Optical Coherence Tomography in Neurological Practice: Utility and Applicability Across Neurological Diseases (OCt.IN.N)
Italy1,050 participantsStarted 2023-10-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Absence of neurological disease.
. Age greater than 18 years.
. Signed informed consent to study participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Annual rate of peripapillary RNFL thinning in patients with Multiple Sclerosis vs healthy controls
Timeframe: Baseline, 6, 12, 18, and 24 months
2
Annual rate of peripapillary RNFL thinning in patients with Alzheimer's Disease vs healthy controls
Timeframe: Baseline, 6, 12, 18, and 24 months
3
Annual rate of peripapillary RNFL thinning in patients with Parkinson's Disease vs healthy controls
Timeframe: Baseline, 6, 12, 18, and 24 months
4
Annual rate of macular GCL thinning in patients with Multiple Sclerosis disease vs healthy controls
Timeframe: Baseline, 6, 12, 18, and 24 months
5
Annual rate of macular GCL thinning in patients with Alzheimer's Disease vs healthy controls
Timeframe: Baseline, 6, 12, 18, and 24 months
6
Annual rate of macular GCL thinning in patients with Parkinson's Disease vs healthy controls
. Willingness and ability to undergo all study visits and procedures.
Exclusion criteria
. 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.
. Refusal to participate or withdrawal of informed consent.
. Known or confirmed ocular pathology identified during examination.
. Inability to understand instructions given by investigators.
Annual rate of macular IPL thinning in patients with Multiple Sclerosis vs healthy controls
Timeframe: Baseline, 6, 12, 18, and 24 months
8
Annual rate of macular IPL thinning in patients with Alzheimer's Disease vs healthy controls
Timeframe: Baseline, 6, 12, 18, and 24 months
9
Annual rate of macular IPL thinning in patients with Parkinson's Disease vs healthy controls