Choroid DiseaseMOPASNCT03532867
Study of Changes in Retrofoveolar Choroidal Thickness During Aerobic Exercise
A study testing Examination of pressures before stopping the exercise, Examination of pressure during the exercise and Examination of pressures after stopping the exercise in people with Choroid Disease and Hypertension Ocular, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Study the change of retrofoveolar choroidal thickness measured by optical coherence tomography during aerobic exercise inducing an increase in systolic blood pressure in healthy subjects.Ten healthy participants will perform an exercise (riding a bicycle ergometer) and will be examined with EDI-OCT. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Choroid Disease, Hypertension Ocular
- What is being tested?
- Examination of pressures before stopping the exercise, Examination of pressure during the exercise and Examination of pressures after stopping the exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2019to Jul 2020
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients wishing to perform a standardized aerobic exercise stress test Best - Corrected visual acuity ≥ 10/10 (Monoyer scale)
- Absence of ocular pathologies
- Absence of previous ocular surgery
- Refraction between -4 diopters and +4 diopters
- Absence of alcohol or drug abuse
- Absence of systemic pathologies
- Absence of regular doping ;
Who cannot join
- History of ocular pathologies, intraocular surgery
- Macular or papillary abnormality seen at OCT
- History of systemic pathology such as high blood pressure, diabetes
- Exercise <72 hours
- Intake of coffee or tea <48 hours
- High myopia (axial length> 26mm) or high hyperopia (axial length <19mm) -
- Professional athlete ;Sedentary patient doing sports less than twice a month ; smocking <24 hours
- Pharmacological pupillary dilation <72 hours
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Toulouse
Toulouse, 31059
Vincent SOLER, MD, 5 61 77 71 74 ext. 33, soler.v@chu-toulouse.fr
Isabelle OLIVIER, PhD, 5 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
Official title: Study of Changes in Retrofoveolar Choroidal Thickness Measured by Optical Coherence Tomography During Aerobic Exercise Inducing an Increase in Systolic Blood Pressure in Healthy Subjects
Study the change of retrofoveolar choroidal thickness measured by optical coherence tomography during aerobic exercise inducing an increase in systolic blood pressure in healthy subjects.Ten healthy participants will perform an exercise (riding a bicycle ergometer) and will be examined with EDI-OCT. Each participant will be scanned before exercise, during the exercise and afterwards at 0 and 5 min. Each OCT measurement will be coupled to the arterial blood pressure evaluation.
Read the detailed description
Currently there is a growing interest in the study of the choroid in the pathogenesis of many ocular pathologies such as central serous chorioretinitis1, age-related macular degeneration, diabetic retinopathy, and myopia. Moreover, the recent development of new imaging methods allows the exploration of the normal and pathological processes of the choroid. In particular, the Enhanced Depth Imaging (EDI) mode in Optical Coherence Tomography (OCT) provides cross-sectional imaging of the choroid and in vivo measurement of its thickness. Understanding the factors that would modify the choroidal thickness would make it possible to better understand the pathophysiology of many chorioretinal pathologies and would help to guide therapeutics in the future.
However, systemic changes induced by physical activity, and in particular changes in systolic blood pressure, could be responsible for changes in the choroidal blood flow and thus in the choroidal thickness. The study consists in testing ten patients who will perform an exercise testing as part of the practice of a sportive activity. Patients will undergo an OCT in EDI mode to measure the retrofoveolar choroidal thickness during the exercise.
Each OCT image will be coupled to the evaluation of blood pression and heart rate.
Patients are treated in the usual way but the study is an interventional study, with minimal risks and constraints, because of the imaging (OCT image in EDI mode).
- Conditions
- Choroid Disease, Hypertension Ocular
- Being tested
- Examination of pressures before stopping the exercise, Examination of pressure during the exercise, Examination of pressures after stopping the exercise
- Keywords
- Exercise Test, Blood Pressure, Choroid
- Medical subject headings
- Choroid Diseases, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Examination of pressures before stopping the exerciseOther
In healthy volunteers performing aerobic physical exercise in the Department of Sports Medicine, the investigators will perform different examinations :
- Macular and peri-papillary OCT in EDI mode (bilateral examination),
- Intraocular pressure (bilateral examination)
- Measurement of systolic and diastolic blood pressure
- Heart rate measurement Exercise testing will be performed on bicycle measuring session with 10 minutes at moderate intensity ( 30% OF MPA), 10 minutes at sustained intensity ( 50% of MPA) and 3 minutes at maximum (70% of MPA).
The theoretical maximal aerobic power was calculated by a mathematical formula.
Examination of pressure during the exerciseOther
In healthy volunteers performing aerobic physical exercise in the Department of Sports Medicine, the investigators will perform different examinations :
- Macular and peri-papillary OCT in EDI mode (bilateral examination),
- Intraocular pressure (bilateral examination)
- Measurement of systolic and diastolic blood pressure
- Heart rate measurement Exercise testing will be performed on bicycle measuring session with 10 minutes at moderate intensity ( 30% OF MPA), 10 minutes at sustained intensity ( 50% of MPA) and 3 minutes at maximum (70% of MPA).
The theoretical maximal aerobic power was calculated by a mathematical formula.
Examination of pressures after stopping the exerciseOther
In healthy patients performing aerobic physical exercise in the Department of Sports Medicine, the investigators will perform different examinations :
- Macular and peri-papillary OCT in EDI mode (bilateral examination),
- Intraocular pressure (bilateral examination)
- Measurement of systolic and diastolic blood pressure
- Heart rate measurement Exercise testing will be performed on bicycle measuring session with 10 minutes at moderate intensity ( 30% OF MPA), 10 minutes at sustained intensity ( 50% of MPA) and 3 minutes at maximum (70% of MPA).
The theoretical maximal aerobic power was calculated by a mathematical formula.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | After an ophthalmic consultation, the healthy volunteers are summoned to perform the exercise test in the form of an aerobic exercise on an ergometric bicycle with 3 different intensity levels calculated on the theoretical maximum aerobic power.
The OCT examination in the EDI mode, centered on the macular and peri-papillary region, as well as the systolic and diastolic blood pressure and the heart rate.
In healthy patients performing aerobic physical exercise in the Department of Sports Medicine , the investigators will perform the following Intervention :
* Examination of pressures before stopping the exercise
* Examination of pressure during the exercise
* Examination of pressures after stopping the exercise Receives: Other: Examination of pressures before stopping the exercise; Other: Examination of pressure during the exercise; Other: Examination of pressures after stopping the exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of macular choroidal thickness before, during and after standardized aerobic exercise inducing a standardized increase in arterial systolic pressure
Measurement of macular choroidal thickness before, during and after standardized aerobic exercise inducing a standardized increase in arterial systolic pressure: the choroidal thickness will be determined thanks to the OCT as the vertical distance between the outer line of the pigmentary epithelium and the internal line of the sclera centered on the fovea thanks to the EDI measurement mode.
Measured: 1 day
Secondary outcomes (4)
Measurement of systolic and diastolic blood pressure
Before, during and after the effort The effort is with sustained intensity and maximum intensity. It's a standardized aerobic exercise inducing an increase in systolic arterial blood pressure and arterial diastolic blood pressure.
An OCT examination in EDI mode focused on the systolic and diastolic blood pressure are taken before the start of the exercise test, during the phase of moderate effort, sustained and maximum, at the end of the effort and 5 minutes after stopping.
Measured: 2 hours (during the consultation)
Measurement of intraocular pressure
Measurement of intraocular pressure systolic and diastolic : Before, during and after the effort The effort with sustained intensity and maximum intensity. It's a standardized aerobic exercise inducing an increase in systolic arterial blood pressure and arterial diastolic blood pressure.
An OCT examination in EDI mode focused on the macular and peripapillary region the systolic and diastolic blood pressure are taken before the start of the exercise test, during the phase of moderate effort, sustained and maximum, at the end of the effort and 5 minutes after stopping.
Measured: 2 hours (during the consultation)
Analysis of the peripapillary choroid in OCT
Before, during and after the effort Patients presenting for consultation to perform an exercise test in the sports medicine department benefit from an ophthalmological consultation with measurement : The effort with sustained intensity and maximum intensity. It's a standardized aerobic exercise inducing an increase in systolic arterial blood pressure and arterial diastolic blood pressure.
An OCT examination in EDI mode focused on the macular and peripapillary region during the phase of moderate effort, sustained and maximum, at the end of the effort and 5 minutes after stopping.
Measured: 2 hours (during the consultation)
Analysis of the retinal vascular caliber on the infrared image of the OCT
Analysis of the retinal vascular caliber on the infrared image of the OCT : Before, during and after the effort The effort with sustained intensity and maximum intensity. It's a standardized aerobic exercise inducing an increase in systolic arterial blood pressure and arterial diastolic blood pressure.
An OCT examination in EDI mode focused on the macular and peripapillary region during the phase of moderate effort, sustained and maximum, at the end of the effort and 5 minutes after stopping.
Measured: 2 hours (during the consultation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study startJul 2019 (estimated)
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroid DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- To study the changes in choroidal thickness of the macular region during aerobic exercise inducing an increase in systolic and diastolic blood pressure in healthy subjects measured by Optical Coherence Tomography (OCT) provides cross-sectional imaging of the choroid and in vivo measurement of its thickness Patients are treated in the usual way but the study is an interventional study, with minimal risks and constraints, because of the imaging (OCT image in EDI mode)
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent SOLER, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532867
- Sponsor's protocol ID
- RC31/17/0059
- Other IDs
- 2017-A02206-47
- Acronym
- MOPAS
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Changes in Retrofoveolar Choroidal Thickness Measured by Optical Coherence Tomography During Aerobic Exercise Inducing an Increase in Systolic Blood Pressure in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03532867
- Acronym / sponsor ID
- MOPAS / RC31/17/0059
- Conditions
- Choroid Disease, Hypertension Ocular
- Keywords
- Exercise Test, Blood Pressure, Choroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 22 May 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.
Study the change of retrofoveolar choroidal thickness measured by optical coherence tomography during aerobic exercise inducing an increase in systolic blood pressure in healthy subjects.Ten healthy participants will perform an exercise (riding a bicycle ergometer) and will be examined with EDI-OCT. Each participant will be scanned before exercise, during the exercise and afterwards at 0 and 5 min. Each OCT measurement will be coupled to the arterial blood pressure evaluation.
Detailed description
Currently there is a growing interest in the study of the choroid in the pathogenesis of many ocular pathologies such as central serous chorioretinitis1, age-related macular degeneration, diabetic retinopathy, and myopia. Moreover, the recent development of new imaging methods allows the exploration of the normal and pathological processes of the choroid. In particular, the Enhanced Depth Imaging (EDI) mode in Optical Coherence Tomography (OCT) provides cross-sectional imaging of the choroid and in vivo measurement of its thickness. Understanding the factors that would modify the choroidal thickness would make it possible to better understand the pathophysiology of many chorioretinal pathologies and would help to guide therapeutics in the future.
However, systemic changes induced by physical activity, and in particular changes in systolic blood pressure, could be responsible for changes in the choroidal blood flow and thus in the choroidal thickness. The study consists in testing ten patients who will perform an exercise testing as part of the practice of a sportive activity. Patients will undergo an OCT in EDI mode to measure the retrofoveolar choroidal thickness during the exercise.
Each OCT image will be coupled to the evaluation of blood pression and heart rate.
Patients are treated in the usual way but the study is an interventional study, with minimal risks and constraints, because of the imaging (OCT image in EDI mode).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To study the changes in choroidal thickness of the macular region during aerobic exercise inducing an increase in systolic and diastolic blood pressure in healthy subjects measured by Optical Coherence Tomography (OCT) provides cross-sectional imaging of the choroid and in vivo measurement of its thickness Patients are treated in the usual way but the study is an interventional study, with minimal risks and constraints, because of the imaging (OCT image in EDI mode)
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Other: Examination of pressures before stopping the exercise, Other: Examination of pressure during the exercise, Other: Examination of pressures after stopping the exerciseAfter an ophthalmic consultation, the healthy volunteers are summoned to perform the exercise test in the form of an aerobic exercise on an ergometric bicycle with 3 different intensity levels calculated on the theoretical maximum aerobic power. The OCT examination in the EDI mode, centered on the macular and peri-papillary region, as well as the systolic and diastolic blood pressure and the heart rate. In healthy patients performing aerobic physical exercise in the Department of Sports Medicine , the investigators will perform the following Intervention : * Examination of pressures before stopping the exercise * Examination of pressure during the exercise * Examination of pressures after stopping the exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male patients wishing to perform a standardized aerobic exercise stress test Best - Corrected visual acuity ≥ 10/10 (Monoyer scale)
- Absence of ocular pathologies
- Absence of previous ocular surgery
- Refraction between -4 diopters and +4 diopters
- Absence of alcohol or drug abuse
Key exclusion criteria (8 listed)
- History of ocular pathologies, intraocular surgery
- Macular or papillary abnormality seen at OCT
- History of systemic pathology such as high blood pressure, diabetes
- Exercise <72 hours
- Intake of coffee or tea <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 |
|---|---|---|
| Examination of pressures before stopping the exerciseIn healthy volunteers performing aerobic physical exercise in the Department of Sports Medicine, the investigators will perform different examinations : * Macular and peri-papillary OCT in EDI mode (bilateral examination), * Intraocular pressure (bilateral examination) * Measurement of systolic and diastolic blood pressure * Heart rate measurement Exercise testing will be performed on bicycle measuring session with 10 minutes at moderate intensity ( 30% OF MPA), 10 minutes at sustained intensity ( 50% of MPA) and 3 minutes at maximum (70% of MPA). The theoretical maximal aerobic power was calculated by a mathematical formula. | Other | Healthy volunteers |
| Examination of pressure during the exerciseIn healthy volunteers performing aerobic physical exercise in the Department of Sports Medicine, the investigators will perform different examinations : * Macular and peri-papillary OCT in EDI mode (bilateral examination), * Intraocular pressure (bilateral examination) * Measurement of systolic and diastolic blood pressure * Heart rate measurement Exercise testing will be performed on bicycle measuring session with 10 minutes at moderate intensity ( 30% OF MPA), 10 minutes at sustained intensity ( 50% of MPA) and 3 minutes at maximum (70% of MPA). The theoretical maximal aerobic power was calculated by a mathematical formula. | Other | Healthy volunteers |
| Examination of pressures after stopping the exerciseIn healthy patients performing aerobic physical exercise in the Department of Sports Medicine, the investigators will perform different examinations : * Macular and peri-papillary OCT in EDI mode (bilateral examination), * Intraocular pressure (bilateral examination) * Measurement of systolic and diastolic blood pressure * Heart rate measurement Exercise testing will be performed on bicycle measuring session with 10 minutes at moderate intensity ( 30% OF MPA), 10 minutes at sustained intensity ( 50% of MPA) and 3 minutes at maximum (70% of MPA). The theoretical maximal aerobic power was calculated by a mathematical formula. | Other | Healthy volunteers |
Primary outcome
Measurement of macular choroidal thickness before, during and after standardized aerobic exercise inducing a standardized increase in arterial systolic pressure
Time frame: 1 day
Measurement of macular choroidal thickness before, during and after standardized aerobic exercise inducing a standardized increase in arterial systolic pressure: the choroidal thickness will be determined thanks to the OCT as the vertical distance between the outer line of the pigmentary epithelium and the internal line of the sclera centered on the fovea thanks to the EDI measurement mode.
4 secondary outcomes
Measurement of systolic and diastolic blood pressure
Time frame: 2 hours (during the consultation)
Measurement of intraocular pressure
Time frame: 2 hours (during the consultation)
Analysis of the peripapillary choroid in OCT
Time frame: 2 hours (during the consultation)
Analysis of the retinal vascular caliber on the infrared image of the OCT
Time frame: 2 hours (during the consultation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Vincent SOLER, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Examination of pressures before stopping the exercise, Examination of pressure during the exercise and Examination of pressures after stopping the exercise in people with Choroid Disease and Hypertension Ocular, run by University Hospital, Toulouse 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 7 inclusion and 8 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 18 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent SOLER, MD (5 61 77 71 74 ext. 33, soler.v@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of macular choroidal thickness before, during and after standardized aerobic exercise inducing a standardized increase in arterial systolic pressure (time frame: 1 day). 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 18 Apr 2019.