Trials / Completed
CompletedNCT04153773
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 90 (actual)
- Sponsor
- Mansoura University Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 45 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | OCT | 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). |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2019-06-01
- Completion
- 2019-09-01
- First posted
- 2019-11-06
- Last updated
- 2019-11-13
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT04153773. Inclusion in this directory is not an endorsement.