OCT and Early Cognitive Impairment in Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Retinal Thickness as a Potential Biomarker of Neurodegeneration and Early Cognitive Impairment in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Diagnostic Test: OCT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>60 Patient | Diagnostic Test: OCT<br>* The degree of physical disability was assessed by using the Expanded Disability Status Scale (EDSS). The EDSS score ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Neurocognitive functions were evaluated using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) that includes the following tests: Symbol Digit Modalities Test (SDMT) that is used for assessment of information processing speed. California Verbal Learning Test - 2nd edition (CVLT-II) . Brief Visuospatial Memory Test-Revised (BVMT-R) OCT assessment was performed by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans . Each eye for every patient was assessed by measuring the thickness of RNFL and GCC, respecting presence or absence of the previous history of optic neuritis (ON).<br>* Other names: Cognitive assessment;|
| Group 2<br>30 Control subject | Diagnostic Test: OCT<br>* The degree of physical disability was assessed by using the Expanded Disability Status Scale (EDSS). The EDSS score ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Neurocognitive functions were evaluated using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) that includes the following tests: Symbol Digit Modalities Test (SDMT) that is used for assessment of information processing speed. California Verbal Learning Test - 2nd edition (CVLT-II) . Brief Visuospatial Memory Test-Revised (BVMT-R) OCT assessment was performed by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans . Each eye for every patient was assessed by measuring the thickness of RNFL and GCC, respecting presence or absence of the previous history of optic neuritis (ON).<br>* Other names: Cognitive assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical coherence tomography | OCT imaging was performed by spectral domain-optical coherence tomography to assess the retinal thickness. | 24-48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive assessment | Neurocognitive functions were evaluated using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) | 24-48 hours | 
| Expanded Disability Status Scale (EDSS) | The EDSS score ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. | 24 hours |