OCT and Early Cognitive Impairment in Multiple Sclerosis

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


Lead Sponsor: Mansoura University Hospital

Source Mansoura University Hospital
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.

Overall Status Completed
Start Date August 1, 2018
Completion Date September 1, 2019
Primary Completion Date June 1, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Optical coherence tomography 24-48 hours
Secondary Outcome
Measure Time Frame
Cognitive assessment 24-48 hours
Expanded Disability Status Scale (EDSS) 24 hours
Enrollment 90

Intervention Type: Diagnostic Test

Intervention Name: OCT

Description: 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).


Sampling Method: Probability Sample


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.

Gender: All

Minimum Age: 20 Years

Maximum Age: 45 Years

Overall Official
Last Name Role Affiliation
Esmael M Ahmed, MD Principal Investigator Assistant Prof of Neurology
Facility: Mansoura University Hospital
Location Countries


Verification Date

November 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Mansoura University Hospital

Investigator Full Name: Ahmed Esmael

Investigator Title: Assistant Prof of Neurology

Has Expanded Access No
Condition Browse
Arm Group

Label: Group 1

Description: 60 Patient

Label: Group 2

Description: 30 Control subject

Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Retrospective

Source: ClinicalTrials.gov