Assessing eye changes in patients with multiple sclerosis

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.