Assessing eye changes in patients with multiple sclerosis
Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis
This study is testing how changes in the eyes of people with multiple sclerosis relate to their condition, using advanced imaging techniques to see if these changes can help us understand the disease better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, Austria) |
| Trial ID | NCT03401879 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between retinal changes and multiple sclerosis (MS) by utilizing advanced imaging techniques. It aims to explore how alterations in the eye's vascular and neural structures correlate with the neurodegenerative processes in MS patients. Participants will undergo non-invasive assessments using tools like Dynamic Vessel Analyzer and Optical Coherence Tomography to evaluate ocular blood flow and structural integrity. The study includes both healthy individuals and those diagnosed with relapsing-remitting MS who have experienced acute optic neuritis.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with a diagnosis of relapsing-remitting multiple sclerosis and a history of acute optic neuritis.
Not a fit: Patients with significant ocular abnormalities or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of MS and lead to improved diagnostic and monitoring strategies for patients.
How similar studies have performed: Previous studies have shown promising results in using ocular imaging to assess neurological conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria for healthy subjects: * Men and women aged over 18 years * Non-smokers * Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant * Normal ophthalmic findings, ametropy \< 6 Dpt. Inclusion criteria for patients with MS: * Men and women aged over 18 years * Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to clinical evaluation and McDonald criteria (revision 2010) * History of AON in one eye at least one year ago * Non-smokers * Normal ophthalmic findings, ametropy \< 6 Dpt. * Adequate visual acuity to allow participation in the ocular blood flow measurements * A potential participant has to be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except MS therapy itself which will be recorded separately) for at least 30 days prior inclusion, if considered relevant by the investigator. Any of the following will exclude a healthy subject from the study: * Diagnosis of "possible MS" according to the McDonald criteria (revision 2010) * Presence or history of a severe medical condition as judged by the clinical investigator * Untreated Arterial hypertension * History or family history of epilepsy * Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator * Family history of MS, optic neuritis, neuromyelitis optica (NMO, Devic disease) or NMO spectrum disorders * History of inflammatory or infectious disease of central nervous system * Best corrected visual acuity \< 0.5 Snellen * Ametropy ≥ 6Dpt * Pregnancy or planned pregnancy * Alcoholism or substance abuse Any of the following will exclude a patient from the study: * Presence or history of a severe medical condition other than MS as judged by the clinical investigator * History of neuromyelitis optica (NMO, Devic disease) or NMO spectrum disorders * History of inflammatory or infectious disease of central nervous system other than MS * Untreated Arterial hypertension * History or family history of epilepsy * Presence of any abnormalities preventing reliable measurements in the study eye as judged by the investigator * Best corrected visual acuity \< 0.5 Snellen * Ametropy ≥ 6 Dpt * Pregnancy, planned pregnancy * Significant neurological disease other than MS, if considered relevant by the investigator * Alcoholism or substance abuse
Where this trial is running
Vienna, Austria
- Department of Clinical Pharmacology, Medical University of Vienna — Vienna, Austria, Austria (Recruiting)
Study contacts
- Principal investigator: Gerhard Garhöfer, MD — Department of Clinical Pharmacology, Medical University of Vienna
- Study coordinator: Gerhard Garhöfer, MD
- Email: gerhard.garhoefer@medunwien.ac.at
- Phone: 0043140400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.