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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04153773
Enrollment
90
Registered
2019-11-06
Start date
2018-08-01
Completion date
2019-09-01
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

DIAGNOSTIC_TESTOCT

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: 1. Symbol Digit Modalities Test (SDMT) that is used for assessment of information processing speed. 2. California Verbal Learning Test - 2nd edition (CVLT-II) . 3. 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).

Sponsors

Mansoura University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Optical coherence tomography24-48 hoursOCT imaging was performed by spectral domain-optical coherence tomography to assess the retinal thickness.

Secondary

MeasureTime frameDescription
Cognitive assessment24-48 hoursNeurocognitive functions were evaluated using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Expanded Disability Status Scale (EDSS)24 hoursThe EDSS score ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026