Multiple Sclerosis, Relapsing-RemittingNCT05218317
Evaluation of Relapse Presence in Multiple Sclerosis
An observational study of Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis Relapse, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis Relapse
- What is being tested?
- in-vivo Corneal Confocal Microscopy
- Type of treatment
- Injection or infusion
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Fifty-eight patients with RRMS and 30 HCs were included in the study. The RRMS patients were divided into two subgroups: 1) Thirty-one patients (MS-Control) who were followed up with the diagnosis of RRMS, 2) Twenty-seven patients (MS-Relapse) for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Relapse Presence in Multiple Sclerosis Patients by Cross-Sectional In-Vivo Corneal Confocal Microscopy
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.
- Being tested
- in-vivo Corneal Confocal Microscopy
- Keywords
- multiple sclerosis, in-vivo corneal confocal microscopy, relapse, inflammation, neurodegeneration, neuroregeneration
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Recurrence, Inflammation, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-vivo Corneal Confocal MicroscopyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| MS-Relapse | Twenty-seven patients (MS-Relapse) for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse.
The diagnosis of RRMS and the new relapse was confirmed and decided by a senior neurologist (K.A) of Marmara University Department of Neurology, according to the revised McDonald criteria, based on clinical and radiological findings These subjects underwent Corneal Confocal Microscopy (IVCM). Receives: Diagnostic Test: in-vivo Corneal Confocal Microscopy | |
| MS-Control | Thirty-one patients (MS-Control) who were followed up with the diagnosis of RRMS The diagnosis of RRMS and the new relapse was confirmed and decided by a senior neurologist (K.A) of Marmara University Department of Neurology, according to the revised McDonald criteria, based on clinical and radiological findings.
These subjects underwent Corneal Confocal Microscopy (IVCM). Receives: Diagnostic Test: in-vivo Corneal Confocal Microscopy | |
| Healthy Controls | Thirty healthy age and gender similar population These subjects underwent Corneal Confocal Microscopy (IVCM). Receives: Diagnostic Test: in-vivo Corneal Confocal Microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal nerve fiber density (CNFD)
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.
Measured: Baseline
Corneal nerve fiber density (CNFD)
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.
Measured: 6 Month
Corneal nerve branch density (CNBD)
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.
Measured: Baseline
Corneal nerve branch density (CNBD)
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.
Measured: 6 Month
Corneal nerve fiber length (CNFL)
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.
Measured: Baseline
Corneal nerve fiber length (CNFL)
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL.
Measured: 6 Months
Secondary outcomes (2)
Dendritic Cells
the number of DCs counted by ImageJ's Cell Counter plug-in
Measured: Baseline
Dendritic Cells
the number of DCs counted by ImageJ's Cell Counter plug-in
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Jan 2021
- Primary completion1 Oct 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218317
- Sponsor's protocol ID
- 09.2021.240
- Status last verified
- Jan 2022
- First submitted
- 20 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Relapse Presence in Multiple Sclerosis Patients by Cross-Sectional In-Vivo Corneal Confocal Microscopy
- ClinicalTrials.gov ID
- NCT05218317
- Acronym / sponsor ID
- 09.2021.240
- Keywords
- multiple sclerosis, in-vivo corneal confocal microscopy, relapse, inflammation, neurodegeneration, neuroregeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MS-Relapse | – | Diagnostic Test: in-vivo Corneal Confocal MicroscopyTwenty-seven patients (MS-Relapse) for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse. The diagnosis of RRMS and the new relapse was confirmed and decided by a senior neurologist (K.A) of Marmara University Department of Neurology, according to the revised McDonald criteria, based on clinical and radiological findings These subjects underwent Corneal Confocal Microscopy (IVCM). |
| MS-Control | – | Diagnostic Test: in-vivo Corneal Confocal MicroscopyThirty-one patients (MS-Control) who were followed up with the diagnosis of RRMS The diagnosis of RRMS and the new relapse was confirmed and decided by a senior neurologist (K.A) of Marmara University Department of Neurology, according to the revised McDonald criteria, based on clinical and radiological findings. These subjects underwent Corneal Confocal Microscopy (IVCM). |
| Healthy Controls | – | Diagnostic Test: in-vivo Corneal Confocal MicroscopyThirty healthy age and gender similar population These subjects underwent Corneal Confocal Microscopy (IVCM). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Fifty-eight patients with RRMS and 30 HCs were included in the study. The RRMS patients were divided into two subgroups: 1) Thirty-one patients (MS-Control) who were followed up with the diagnosis of RRMS, 2) Twenty-seven patients (MS-Relapse) for whom the administration of intravenous corticosteroids was decided due to the diagnosis of new relapse.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| in-vivo Corneal Confocal MicroscopyAll 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. | Diagnostic test | Healthy Controls, MS-Control, MS-Relapse |
Primary outcome
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Dendritic Cells
Time frame: Baseline
Dendritic Cells
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting and Multiple Sclerosis Relapse, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal nerve fiber density (CNFD) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.