Retinal Vascular DisorderMARETINENCT03864380
Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort
An observational study of Retinal Vascular Disorder and Sport Injury, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The cardiovascular parameters of prolonged physical exercice have been studied, but very little data is available about the retinal vascularization. The eye allows in vivo visualization of micro-vascularisation and is considered as an excellent marker of general vascular condition. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Vascular Disorder, Sport Injury
- What is being tested?
- Color retinography, OCT-A and Blood pressure measurement
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2019to 6 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Person running a marathon
Who may be able to join
- Person registered at the 2019 Paris Marathon
Who cannot join
- Ophthalmological disorders making access to the fundus impossible for both eyes
Trial locations and contacts
1 site in 1 country.
About this study
The cardiovascular parameters of prolonged physical exercice have been studied, but very little data is available about the retinal vascularization.
The eye allows in vivo visualization of micro-vascularisation and is considered as an excellent marker of general vascular condition.
Read more
The marathon is an intense and prolonged exercise (running 42.195 km) in aerobic environment. Thus the investigators propose to study the vascular parameters of the retina, before and after this physical exercise.
This will allow : 1) to collect information on the physiology of the retinal vascularization to prolonged effort, 2) to detect any retinal damage (haemorrhages, edema, occlusion ...), not known to date.
The results may highlight vascular effects related to retinal hypoxia (venous tortuosity, haemorrhage, venous occlusion, hypoxic edema). Furthermore the results may urge prevention in this sport more and more democratized.
the investigators hypothesized that prolonged physical exercice causes a change in retinal vascularization.
- Conditions
- Retinal Vascular Disorder, Sport Injury
- Being tested
- Color retinography, OCT-A, Blood pressure measurement
- Keywords
- Retinal Vascularization, Intense effort, OCT-A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color retinographyDiagnostic test
Non mydriatic color retinography within 1 month before and within 1 hour after the marathon
OCT-ADiagnostic test
Optical Coherence Tomography - Angiography within 1 month before and within 1 hour after the marathon
Blood pressure measurementDiagnostic test
Blood pressure measurement within 1 month before and within 1 hour after the marathon
| Study group | Role | What they receive |
|---|---|---|
| Person running a marathon | Exams performed before (1 month maximum) and after the marathon (1 hour maximum) :
Color retinography Optical Coherence Tomography - Angiography (OCT-A) Blood pressure measurement Receives: Diagnostic Test: Color retinography; Diagnostic Test: OCT-A; Diagnostic Test: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Density of retinal vascular plexuses
Percentage, Measurement with OCT-A
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start15 Mar 2019
- Primary completion14 Apr 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal Vascular DisorderStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine MAUGET FAYSSE, Principal investigator, Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864380
- Sponsor's protocol ID
- MMT_2018_10
- Acronym
- MARETINE
- Status last verified
- May 2019
- First submitted
- 4 Mar 2019
- Last updated
- 7 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mauget-Faysse M, Arej N, Paternoster M, Zuber K, Derrien S, Thevenin S, Alonso AS, Salviat F, Lafolie J, Vasseur V. Retinal and choroidal blood flow variations after an endurance exercise: A real-life pilot study at the Paris Marathon. J Sci Med Sport. 2021 Nov;24(11):1100-1104. doi: 10.1016/j.jsams.2021.03.013. Epub 2021 Mar 30.
PubMed 33824079
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Variation of the Retinal Vascularization After a Prolonged Effort
- ClinicalTrials.gov ID
- NCT03864380
- Acronym / sponsor ID
- MARETINE / MMT_2018_10
- Conditions
- Retinal Vascular Disorder, Sport Injury
- Keywords
- Retinal Vascularization, Intense effort, OCT-A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 6 Mar 2019 (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.
The cardiovascular parameters of prolonged physical exercice have been studied, but very little data is available about the retinal vascularization.
The eye allows in vivo visualization of micro-vascularisation and is considered as an excellent marker of general vascular condition.
The marathon is an intense and prolonged exercise (running 42.195 km) in aerobic environment. Thus the investigators propose to study the vascular parameters of the retina, before and after this physical exercise.
This will allow : 1) to collect information on the physiology of the retinal vascularization to prolonged effort, 2) to detect any retinal damage (haemorrhages, edema, occlusion ...), not known to date.
The results may highlight vascular effects related to retinal hypoxia (venous tortuosity, haemorrhage, venous occlusion, hypoxic edema). Furthermore the results may urge prevention in this sport more and more democratized.
the investigators hypothesized that prolonged physical exercice causes a change in retinal vascularization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Person running a marathon | – | Diagnostic Test: Color retinography, Diagnostic Test: OCT-A, Diagnostic Test: Blood pressure measurementExams performed before (1 month maximum) and after the marathon (1 hour maximum) : Color retinography Optical Coherence Tomography - Angiography (OCT-A) Blood pressure measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Person running a marathon
Key inclusion criteria (1 listed)
- Person registered at the 2019 Paris Marathon
Key exclusion criteria (1 listed)
- Ophthalmological disorders making access to the fundus impossible for both eyes
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 |
|---|---|---|
| Color retinographyNon mydriatic color retinography within 1 month before and within 1 hour after the marathon | Diagnostic test | Person running a marathon |
| OCT-AOptical Coherence Tomography - Angiography within 1 month before and within 1 hour after the marathon | Diagnostic test | Person running a marathon |
| Blood pressure measurementBlood pressure measurement within 1 month before and within 1 hour after the marathon | Diagnostic test | Person running a marathon |
Primary outcome
Density of retinal vascular plexuses
Time frame: up to 1 hour
Percentage, Measurement with OCT-A
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 7 May 2019.
- Derived from this study: PubMed 33824079Mauget-Faysse M, Arej N, Paternoster M, Zuber K, Derrien S, Thevenin S, Alonso AS, Salviat F, Lafolie J, Vasseur V. Retinal and choroidal blood flow variations after an endurance exercise: A real-life pilot study at the Paris Marathon. J Sci Med Sport. 2021 Nov;24(11):1100-1104. doi: 10.1016/j.jsams.2021.03.013. Epub 2021 Mar 30.
- Individual participant dataSharing planned: Undecided
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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.
Martine MAUGET FAYSSE principal investigator
Fondation A. de Rothschild
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 Retinal Vascular Disorder and Sport Injury, run by Fondation Ophtalmologique Adolphe de Rothschild 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 1 inclusion and 1 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 7 May 2019. 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?
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?
Density of retinal vascular plexuses (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03864380, which also lists 1 linked publication.
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 7 May 2019.