REtinal Markers In Neuroinflammatory Diseases ("REMIND")
Retinal Markers in Neuroinflammatory Diseases: a Prospective Observational Study
University Hospital, Basel, Switzerland
500 participants
Jan 31, 2024
OBSERVATIONAL
Conditions
Summary
The goal of this observational study, including patients with Multiple Sclerosis, patients with other neuroinflammatory diseases and healthy controls, is to determine the predictive value of retinal markers in predicting disease progression. Participants complete a questionnaire and undergo various non-invasive retinal routine clinical examinations.
Eligibility
Inclusion Criteria6
- All groups:
- Age \>18 years old
- Patients with Multiple Sclerosis:
- Diagnosis of Multiple Sclerosis, according to the last revisions of the McDonald Criteria (2017)
- Patients with other neuroinflammatory diseases:
- Diagnosis of Neuromyelitis optica spectrum disorder or Myelin oligodendrocyte glycoprotein antibody disease or other neuroinflammatory disorders other than Multiple Sclerosis
Exclusion Criteria6
- All groups:
- Inability to undergo Optical Coherence Tomography (OCT) and/or retinal vessel imaging (e.g. severe nystagmus that prevents eye fixation on both eyes)
- Presence of any ocular pathology that may interfere with the validity of the OCT/retinal vessel analysis (cataracts, glaucoma, history of refractive defects \>6 D etc.).
- Pregnancy and Lactation
- Healthy Controls
- History of other neurological conditions: participants with a history of other significant neurological conditions that might interfere with the assessment or interpretation of the signs and symptoms will be excluded (e.g. confirmed Stroke, Acute disseminated encephalomyelitis, Chronic inflammatory Demyelinating Disease, Polyneuropathy, etc.)
Interventions
OCT is used to measure: * peripapillary retinal nerve fiber layer (mean thickness in μm) * ganglion cell-inner plexiform layer (volume in mm\^3 and mean thickness in μm) * other retinal layers (inner nuclear layer, outer plexiform layer, outer nerve layer; volumes in mm\^3 and mean thickness in μm). The "scanner laser ophthalmoscopy"-function of the OCT device is used to continuously record the exact location of each participant's fixation point in relation to their fovea and thereby allows the assessment of the fixation instability. In a subgroup of participants, the "angiography"-module of the OCT device is used to image the retinal blood flow and thereby allows to measure the vascular area density of the superficial retinal capillary plexus and deep retinal capillary plexus.
Static retinal vessel analyzer is used to determine: * central retinal arteriolar diameter equivalents (in μm) * central retinal venular diameter equivalents (in μm) * arteriolar-to-venular diameter ratio
In a subgroup of participants, the dynamic retinal vessel analyzer is used to determine the arteriolar ficker light-induced dilatation, venular ficker light-induced dilatation, and Arteriolar constriction, measured in % dilatation in comparison to baseline.
In a subgroup of participants, the laser speckle flowgraphy system is used to measure the relative ocular blood flow as expressed in arbitary units of Mean Blur Rate.
All study participants will be asked to fill in a questionnaire with various questions regarding existing eye diseases, other diseases (including vascular diseases/risk factors), and daily physical activity that could influence the results of the retinal examinations. Physical activity will be assessed using an adapted form of the standardized Global Physical Activity Questionnaire.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06369766