Sclerosis, MultipleMS-EYENCT03508089
Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis
A study testing Ocular fundus on patient with Multiple Sclerosis and Ocular Fundus on voluntary person in people with Sclerosis, Multiple, run by Versailles Hospital at 1 site in France.
Trial summary
It's a pilot, interventional prospective monocentric study. It aims to compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between patients with multiple sclerosis and controls using the technique of adaptive optics. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sclerosis, Multiple
- What is being tested?
- Ocular fundus on patient with Multiple Sclerosis and Ocular Fundus on voluntary person
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 22 Aug 2017to 30 Jun 2018
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Contraindication to the use oxygen (O2): Acute or chronic respiratory insufficiency
- Pregnant or lactating woman
- Inability to see fundus (cataract), retinopathy, glaucoma
- Use of vasoactive substances (eg nasal decongestants, triptans, alkaloids) in the last 48 hours
- Use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, ..) and steroids (corticosteroids) in the last 48 hours
- Known Diabetes or taking antidiabetics in the last 48 hours
Show all 11Show fewer
- Use of statins in the last 48 hours
- Known hypertension or antihypertensive treatment in the last 48 hours
- Any cardiac pathology (valvulopathy, angina, ventricular arrhythmia or atrial fibrillation), vascular (arteritis obliterating the lower limbs, stenosis of the arteries with encephalic destiny, coronary artery disease) or significant respiratory (asthma, Chronic obstructive pulmonary disease, interstitial pathology)
- Alcohol consumption within 8 hours
- Ophthalmoparesis or incapacitating nystagmus (impossibility of correctly evaluating the fundus)
Trial locations and contacts
1 site in 1 country.
About this study
It's a pilot, interventional prospective monocentric study. It aims to compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between patients with multiple sclerosis and controls using the technique of adaptive optics.
- Conditions
- Sclerosis, Multiple
- Being tested
- Ocular fundus on patient with Multiple Sclerosis, Ocular Fundus on voluntary person
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular fundus on patient with Multiple SclerosisOther
Ocular fundus on patient with Multiple Sclerosis
Ocular Fundus on voluntary personOther
Ocular Fundus on voluntary person
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Other | Not described Receives: Other: Ocular Fundus on voluntary person |
| Multiple Sclerosis Arm | Active comparator | Not described Receives: Other: Ocular fundus on patient with Multiple Sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between multiple sclerosis patients and controls using the adaptive optics technique.
Measured: Day 0
Secondary outcomes (2)
Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter.
Measured: Day 0
Correlate possible changes in arteriolar WLR with internal and external diameter, smoking, age, blood pressure, fatigue (MFIS), cognition (MDT) and disability (EDSS) scores to ambient air and normobaric oxygen.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start22 Aug 2017
- Primary completion26 Oct 2017
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sclerosis, MultipleStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Dan BUCH, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508089
- Sponsor's protocol ID
- P15/18_ MS-EYE
- Acronym
- MS-EYE
- Status last verified
- Apr 2018
- First submitted
- 25 Mar 2018
- Last updated
- 25 Apr 2018
- 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 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03508089
- Acronym / sponsor ID
- MS-EYE / P15/18_ MS-EYE
- Conditions
- Sclerosis, Multiple
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 25 Apr 2018 (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.
It's a pilot, interventional prospective monocentric study. It aims to compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between patients with multiple sclerosis and controls using the technique of adaptive optics.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Other | Other: Ocular Fundus on voluntary person |
| Multiple Sclerosis Arm | Active comparator | Other: Ocular fundus on patient with Multiple Sclerosis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Contraindication to the use oxygen (O2): Acute or chronic respiratory insufficiency
- Pregnant or lactating woman
- Inability to see fundus (cataract), retinopathy, glaucoma
- Use of vasoactive substances (eg nasal decongestants, triptans, alkaloids) in the last 48 hours
- Use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, ..) and steroids (corticosteroids) in the last 48 hours
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 |
|---|---|---|
| Ocular fundus on patient with Multiple SclerosisOcular fundus on patient with Multiple Sclerosis | Other | Multiple Sclerosis Arm |
| Ocular Fundus on voluntary personOcular Fundus on voluntary person | Other | Control Arm |
Primary outcome
To compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between multiple sclerosis patients and controls using the adaptive optics technique.
Time frame: Day 0
2 secondary outcomes
Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter.
Time frame: Day 0
Correlate possible changes in arteriolar WLR with internal and external diameter, smoking, age, blood pressure, fatigue (MFIS), cognition (MDT) and disability (EDSS) scores to ambient air and normobaric oxygen.
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
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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?
A study testing Ocular fundus on patient with Multiple Sclerosis and Ocular Fundus on voluntary person in people with Sclerosis, Multiple, run by Versailles Hospital at 1 site in France.
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 0 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 25 Apr 2018. 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 France. 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?
Results are not available in the source record.
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?
To compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between multiple sclerosis patients and controls using the adaptive optics technique. (time frame: Day 0). 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 25 Apr 2018.