Clinical trial NCT03532867: Study of Changes in Retrofoveolar Choroidal Thickness During Aerobic Exercise
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Choroid Disease
Hypertension Ocular
Keywords: Exercise Test
Blood Pressure
Choroid
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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)
Primary purpose: OTHER

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

* 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 ;

Exclusion Criteria :

* 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

Primary outcomes:
measure: Measurement of macular choroidal thickness before, during and after standardized aerobic exercise inducing a standardized increase in arterial systolic pressure
timeFrame: 1 day
Secondary outcomes:
measure: Measurement of systolic and diastolic blood pressure
timeFrame: 2 hours (during the consultation)
measure: Measurement of intraocular pressure
timeFrame: 2 hours (during the consultation)
measure: Analysis of the peripapillary choroid in OCT
timeFrame: 2 hours (during the consultation)
measure: Analysis of the retinal vascular caliber on the infrared image of the OCT
timeFrame: 2 hours (during the consultation)
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Vincent SOLER, MD
role: PRINCIPAL_INVESTIGATOR
References: