MOPAS: Study of Changes in Retrofoveolar Choroidal Thickness During Aerobic Exercise

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Unknown status

CT.gov ID

NCT03532867

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Choroid Disease Hypertension Ocular	Other: Examination of pressures before stopping the exercise Other: Examination of pressure during the exercise Other: Examination of pressures after stopping the exercise	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

13 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

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)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)

Primary Purpose:

Other

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

Anticipated Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy volunteers 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	Other: Examination of pressures before stopping the exercise 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. Other: Examination of pressure during the exercise 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. Other: Examination of pressures after stopping the exercise 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.

Arm

Intervention/Treatment

Experimental: Healthy volunteers

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

Other: Examination of pressures before stopping the exercise

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.

Other: Examination of pressure during the exercise

Other: Examination of pressures after stopping the exercise

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.

Outcome Measures

Primary Outcome Measures

Measurement of macular choroidal thickness before, during and after standardized aerobic exercise inducing a standardized increase in arterial systolic pressure [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.

Secondary Outcome Measures

Measurement of systolic and diastolic blood pressure [2 hours (during the consultation)]
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.
Measurement of intraocular pressure [2 hours (during the consultation)]
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.
Analysis of the peripapillary choroid in OCT [2 hours (during the consultation)]
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.
Analysis of the retinal vascular caliber on the infrared image of the OCT [2 hours (during the consultation)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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