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Completed

NCT Number: NCT05218317

Evaluation of Relapse Presence in Multiple Sclerosis

Purpose: This study aims to investigate the demonstrability of increased inflammation and neurodegeneration in multiple sclerosis (MS) patients in relapse period compared to MS patients in remission by cross-sectional analysis of in-vivo corneal confocal microscopy (IVCM), and to evaluate the alternations with a second IVCM administered at least 6 months after the relapse period.

Methods: This prospective, non-randomized-controlled, cross-sectional study included 58 MS patients which were grouped regarding the presence of relapse (MS-Relapse group [n=27] and MS-Control group [n=31]), and age-sex matched 30 healthy controls (HC). The corneal nerve fiber density (CNFD), the corneal nerve branch density (CNBD), the corneal nerve fiber length (CNFL), and dendritic cell (DC) density were evaluated in all MS patients and HCs by IVCM. If the patients in the MS-relapse group did not have an attack within 6 months, the same parameters were evaluated with the second IVCM. The patients with a history of optic neuritis or trigeminal symptoms were excluded.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Inflammation Multiple Sclerosis Multiple Sclerosis Relapse Nerve Degeneration Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University

Istanbul, 34899, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse
  • Patients who were followed up with the diagnosis of RRMS
  • Healthy controls

Exclusion criteria

  • Being younger than 18 years old
  • Having any other neurological or metabolic diseases
  • Ophthalmological diseases
  • A history of optic neuritis and trigeminal symptoms
  • Ocular trauma or surgery
  • Contact lens use
  • The patients who had a relapse attack 6 months prior to the study

Treatment and study plan

in-vivo Corneal Confocal Microscopy

Diagnostic Test

All study subjects underwent IVCM (Rostock Cornea Module, Heidelberg Retinal Tomograph III; Heidelberg Engineering, Germany). Before the examination, two drops of topical anesthetic with proparacaine hydrochloride (Alcaine 0.5%, Alcon-Couvreur, Belgium) were applied to both eyes. A carbomer-based gel (Viscotears 0.2%; Dr. Gerhard Mann, Chem.- Pharm. Fabrik, Germany) was used as the coupling agent between the cornea and the applanating cap of IVCM. For correctly positioning the central cornea, all subjects were asked to fixate a determined fixation point and controlled with the device camera. All scans were performed in approximately 5 minutes for each eye by a single experienced ophthalmologist, masked from the subject's disease status.

Primary outcomes

  1. Corneal nerve fiber density (CNFD)

    Time frame: Baseline

    Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.

  2. Corneal nerve fiber density (CNFD)

    Time frame: 6 Month

    Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.

  3. Corneal nerve branch density (CNBD)

    Time frame: Baseline

    Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.

  4. Corneal nerve branch density (CNBD)

    Time frame: 6 Month

    Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.

  5. Corneal nerve fiber length (CNFL)

    Time frame: Baseline

    Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.

  6. Corneal nerve fiber length (CNFL)

    Time frame: 6 Months

    Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.

Secondary outcomes

  1. Dendritic Cells

    Time frame: Baseline

    the number of DCs counted by ImageJ's Cell Counter plug-in

  2. Dendritic Cells

    Time frame: 6 Months

    the number of DCs counted by ImageJ's Cell Counter plug-in

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Evaluation of Relapse Presence in Multiple Sclerosis Patients by Cross-Sectional In-Vivo Corneal Confocal Microscopy

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 1, 2022
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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