Clinical trial NCT04153773: OCT and Early Cognitive Impairment in Multiple Sclerosis
Official title: Retinal Thickness as a Potential Biomarker of Neurodegeneration and Early Cognitive Impairment in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This was a cross-sectional study that was conducted in the Neurology Department of Mansoura University Faculty of Medicine, Egypt. 60 patients with MS were recruited from the period of Aug 2018 to September 2019.

Participants 60 MS patients diagnosed according to the revised McDonald criteria 2010 were included . Both sexes aged 20-45 year were included.

Age and sex matched the healthy control (HC) group which consisted of 30 subjects without any neurological or psychiatric disease and who were not related (within the first or second degree of consanguinity) to a patient with MS.

Brief summary: The aim of this study is to investigate the relationship between cognitive impairment and retinal nerve fiber layer \& ganglion cell inner plexiform layer in MS.

Detailed description: Cross-sectional study design, including 60 patients and 30 healthy controls. Subjects were investigated clinically, underwent retinal optical coherence tomography (OCT) and comprehensive cognitive assessments. The correlation between these modalities was evaluated by Spearman correlation.

Eligibility criteria: Inclusion Criteria:

* 60 MS patients diagnosed according to the revised McDonald criteria 2010 were included
* 30 healthy subjects with age and sex match control group.

Exclusion Criteria:

* Medical disorder other than MS that may grossly affect cognitive functions
* Pregnancy,
* Previous neurological or neuropsychiatric disorders,
* Alcohol or drug abuse,
* MRI findings which could not be attributed to MS.
* Severe visual disorders (\> ± 6.0 dpt.)
* History of ocular surgery, glaucoma or diabetes.

Primary outcomes:
measure: Optical coherence tomography
timeFrame: 24-48 hours
Secondary outcomes:
measure: Cognitive assessment
timeFrame: 24-48 hours
measure: Expanded Disability Status Scale (EDSS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Assistant Prof of Neurology
name: Esmael M Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
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