OCT and Early Cognitive Impairment in Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis
• Interventions: Diagnostic Test: OCT

• Registration Number: NCT04153773
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-09-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-02
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-06
• Last Update Submitted: 2019-11-09
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	OCT	60 Patient
Group 2	OCT	30 Control subject

Primary Outcome Measures

Name	Time	Method
Optical coherence tomography	24-48 hours	OCT imaging was performed by spectral domain-optical coherence tomography to assess the retinal thickness.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt