OCT AngiographyUTMA-RETINANCT07748936
Chorioretinal Imaging, Vascular Biomarkers, and Ultra-Trail: A Pilot Study
A study testing Retinal imaging evaluation of both eyes without dilation before and after the Mont Afrique Ultra Trail and Retinal imaging evaluation of both eyes without dilation, performed in two stages (T0 and T0+11/24H) in people with OCT Angiography and Retinal Microcirculation, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Retinal and choroidal microcirculation is a relevant biomarker of systemic vascular health and lies at the heart of eye-heart interactions. Noninvasive retinal imaging, particularly OCT angiography (OCT-A), now makes it possible to examine retinal and choroidal microvascularization in vivo and to study its… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- OCT Angiography, Retinal Microcirculation, Choroidal Microcirculation
- What is being tested?
- Retinal imaging evaluation of both eyes without dilation before and after the Mont Afrique Ultra Trail and Retinal imaging evaluation of both eyes without dilation, performed in two stages (T0 and T0+11/24H)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Participant who has given free, informed, and verbal consent
- Participant of legal age
- Participant registered for the UTMA 100 km solo ultra-trail race (for the "ultra-trail" group)
- Active subject not exposed to intense physical exertion (>6 hours of exercise) within the 7 days prior to the enrollment visit (for the "active control" group)
- Participant with an estimated physical activity level of 4-6 hours per week (for the "active control" group)
- Participant agreeing to undergo ophthalmological examinations on the same schedule as the ultra-trail group (for the "active control" group)
Who cannot join
- Myopia > 6 diopters
- Type 1 or Type 2 diabetes
- Protected individuals: Minors, individuals under legal protection (guardianship, conservatorship, court order), individuals unable to give informed consent
- Individuals not enrolled in a social security program
- Pregnant or breastfeeding women
- Participants with a systemic or inflammatory vascular condition and cardiovascular risk
Show all 10Show fewer
- Participants with an ocular condition or ophthalmological history likely to impair retinal/choroidal microcirculation or the quality of imaging (vascular and degenerative macular conditions, cataracts)
- Participants being treated with vasoconstrictors
- Tobacco use within 4 hours prior to enrollment
- Caffeine consumption within 1 hour prior to enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Louis ARNOULD, Pr, 03.80.29.34.53 ext. +33, Louis.arnould@chu-dijon.fr
About this study
Retinal and choroidal microcirculation is a relevant biomarker of systemic vascular health and lies at the heart of eye-heart interactions. Noninvasive retinal imaging, particularly OCT angiography (OCT-A), now makes it possible to examine retinal and choroidal microvascularization in vivo and to study its relationship with systemic cardiovascular and neurovascular mechanisms.
Ultra-endurance activities, such as ultra-trail races, induce significant systemic hemodynamic changes, including dehydration, variations in perfusion pressure, prolonged sympathetic activation, and redistribution of blood flow. These physiological adaptations could lead to acute and reversible changes in retinal and choroidal vascular parameters as measured by retinophotography and OCT angiography.
Read more
Several studies suggest that intense physical exercise may be accompanied by significant changes in retinal and choroidal microvascular perfusion. In particular, a significant decrease in the vascular density of the superficial retinal plexus has been observed following intense exercise in a healthy population, suggesting a transient change in retinal microcirculation. Similarly, following a marathon, a decrease in the retinal vascular density index (RVDI) has been reported, likely related to exercise-induced vasoconstriction and a transient reduction in retinal blood flow. This decrease may also be exacerbated by the drop in systemic blood pressure and the relative dehydration observed after the race. More broadly, intense endurance exercise is accompanied by cardiovascular and neurohormonal adaptations, particularly through activation of the renin-angiotensin-aldosterone system, which may modulate ocular perfusion. Scott et al. demonstrated, following a 160-km ultramarathon, significant alterations in left ventricular function and a major elevation in NT-pro-BNP, indicating systemic cardiovascular stress that was markedly greater than that observed after a standard marathon. Furthermore, a multi-omics study conducted during the Ultra-Trail du Mont-Blanc (171 km) revealed systemic oxidative stress, marked inflammation with elevated IL-6 levels, and profound metabolic changes affecting red blood cells-mechanisms recognized as being involved in microvascular dysfunction. However, these variations primarily reflect functional changes in perfusion related to hemodynamic status and autonomic tone, rather than true structural microvascular remodeling or angiogenesis. Metrics derived from OCT angiography, such as vascular density or perfusion density, are in fact sensitive to systemic variations in circulating volume, perfusion pressure, and the quality of the acquired signal.
In this context, the effects of ultra-endurance exercise on the eye remain poorly characterized. Research in this area is necessary to better understand the acute physiological adaptations of ocular microcirculation and to highlight the value of retinal imaging as a tool for cardiovascular research and prevention within an integrated eye-heart approach.
- Being tested
- Retinal imaging evaluation of both eyes without dilation before and after the Mont Afrique Ultra Trail, Retinal imaging evaluation of both eyes without dilation, performed in two stages (T0 and T0+11/24H)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal imaging evaluation of both eyes without dilation before and after the Mont Afrique Ultra TrailOther
Retinal imaging evaluation of both eyes without dilation before and after the Mont Afrique Ultra Trail
Retinal imaging evaluation of both eyes without dilation, performed in two stages (T0 and T0+11/24H)Other
Retinal imaging evaluation of both eyes without dilation, performed in two stages (T0 and T0+11/24H)
| Study group | Role | What they receive |
|---|---|---|
| Participants who ran the 100-km ultra trail | Other | Not described Receives: Other: Retinal imaging evaluation of both eyes without dilation before and after the Mont Afrique Ultra Trail |
| Active controls who were not exposed to intense physical exertion within the past 7 days | Other | Not described Receives: Other: Retinal imaging evaluation of both eyes without dilation, performed in two stages (T0 and T0+11/24H) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in macular vascular density of the superficial capillary plexus between the pre-race and immediate post-race examinations
Assessment of the Acute Impact of Ultra-Endurance Exercise on Retinal Microcirculation (vascular density) and choroidal microcirculation (choroidal thickness and choroidal vascular index) by comparing vascular biomarkers measured by OCT angiography in ultra-trail runners before and 15 to 60 minutes after the race.
Measured: When measuring vascular biomarkers on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start2 Oct 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OCT AngiographyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748936
- Sponsor's protocol ID
- ARNOULD 2026
- Acronym
- UTMA-RETINA
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chorioretinal Imaging, Vascular Biomarkers, and Ultra-Trail: A Pilot Study
- ClinicalTrials.gov ID
- NCT07748936
- Acronym / sponsor ID
- UTMA-RETINA / ARNOULD 2026
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 Aug 2026 (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.
Retinal and choroidal microcirculation is a relevant biomarker of systemic vascular health and lies at the heart of eye-heart interactions. Noninvasive retinal imaging, particularly OCT angiography (OCT-A), now makes it possible to examine retinal and choroidal microvascularization in vivo and to study its relationship with systemic cardiovascular and neurovascular mechanisms.
Ultra-endurance activities, such as ultra-trail races, induce significant systemic hemodynamic changes, including dehydration, variations in perfusion pressure, prolonged sympathetic activation, and redistribution of blood flow. These physiological adaptations could lead to acute and reversible changes in retinal and choroidal vascular parameters as measured by retinophotography and OCT angiography.
Several studies suggest that intense physical exercise may be accompanied by significant changes in retinal and choroidal microvascular perfusion. In particular, a significant decrease in the vascular density of the superficial retinal plexus has been observed following intense exercise in a healthy population, suggesting a transient change in retinal microcirculation. Similarly, following a marathon, a decrease in the retinal vascular density index (RVDI) has been reported, likely related to exercise-induced vasoconstriction and a transient reduction in retinal blood flow. This decrease may also be exacerbated by the drop in systemic blood pressure and the relative dehydration observed after the race. More broadly, intense endurance exercise is accompanied by cardiovascular and neurohormonal adaptations, particularly through activation of the renin-angiotensin-aldosterone system, which may modulate ocular perfusion. Scott et al. demonstrated, following a 160-km ultramarathon, significant alterations in left ventricular function and a major elevation in NT-pro-BNP, indicating systemic cardiovascular stress that was markedly greater than that observed after a standard marathon. Furthermore, a multi-omics study conducted during the Ultra-Trail du Mont-Blanc (171 km) revealed systemic oxidative stress, marked inflammation with elevated IL-6 levels, and profound metabolic changes affecting red blood cells-mechanisms recognized as being involved in microvascular dysfunction. However, these variations primarily reflect functional changes in perfusion related to hemodynamic status and autonomic tone, rather than true structural microvascular remodeling or angiogenesis. Metrics derived from OCT angiography, such as vascular density or perfusion density, are in fact sensitive to systemic variations in circulating volume, perfusion pressure, and the quality of the acquired signal.
In this context, the effects of ultra-endurance exercise on the eye remain poorly characterized. Research in this area is necessary to better understand the acute physiological adaptations of ocular microcirculation and to highlight the value of retinal imaging as a tool for cardiovascular research and prevention within an integrated eye-heart approach.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants who ran the 100-km ultra trail | Other | Other: Retinal imaging evaluation of both eyes without dilation before and after the Mont Afrique Ultra Trail |
| Active controls who were not exposed to intense physical exertion within the past 7 days | Other | Other: Retinal imaging evaluation of both eyes without dilation, performed in two stages (T0 and T0+11/24H) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant who has given free, informed, and verbal consent
- Participant of legal age
- Participant registered for the UTMA 100 km solo ultra-trail race (for the "ultra-trail" group)
- Active subject not exposed to intense physical exertion (>6 hours of exercise) within the 7 days prior to the enrollment visit (for the "active control" group)
- Participant with an estimated physical activity level of 4-6 hours per week (for the "active control" group)
Key exclusion criteria (10 listed)
- Myopia > 6 diopters
- Type 1 or Type 2 diabetes
- Protected individuals: Minors, individuals under legal protection (guardianship, conservatorship, court order), individuals unable to give informed consent
- Individuals not enrolled in a social security program
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Retinal imaging evaluation of both eyes without dilation before and after the Mont Afrique Ultra TrailRetinal imaging evaluation of both eyes without dilation before and after the Mont Afrique Ultra Trail | Other | Participants who ran the 100-km ultra trail |
| Retinal imaging evaluation of both eyes without dilation, performed in two stages (T0 and T0+11/24H)Retinal imaging evaluation of both eyes without dilation, performed in two stages (T0 and T0+11/24H) | Other | Active controls who were not exposed to intense physical exertion within the past 7 days |
Primary outcome
Difference in macular vascular density of the superficial capillary plexus between the pre-race and immediate post-race examinations
Time frame: When measuring vascular biomarkers on Day 1
Assessment of the Acute Impact of Ultra-Endurance Exercise on Retinal Microcirculation (vascular density) and choroidal microcirculation (choroidal thickness and choroidal vascular index) by comparing vascular biomarkers measured by OCT angiography in ultra-trail runners before and 15 to 60 minutes after the race.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retinal imaging evaluation of both eyes without dilation before and after the Mont Afrique Ultra Trail and Retinal imaging evaluation of both eyes without dilation, performed in two stages (T0 and T0+11/24H) in people with OCT Angiography and Retinal Microcirculation, run by Centre Hospitalier Universitaire Dijon 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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louis ARNOULD, Pr (03.80.29.34.53 ext. +33, Louis.arnould@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in macular vascular density of the superficial capillary plexus between the pre-race and immediate post-race examinations (time frame: When measuring vascular biomarkers on Day 1). 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 7 Oct 2026.