Study of Changes in Retrofoveolar Choroidal Thickness During Aerobic Exercise (MOPAS)

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.

Study Overview

• Status: Unknown
• Conditions: Choroid Disease; Hypertension Ocular
• Intervention / Treatment: Other: Examination of pressures before stopping the exercise; Other: Examination of pressure during the exercise; Other: Examination of pressures after stopping the exercise

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 Type: Interventional
• Enrollment (Anticipated): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	2 hours (during the consultation)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Vincent SOLER, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Blood Pressure; Choroid; Exercise Test
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Ocular Hypertension; Choroid Diseases; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Tin Fluorides
• Other Study ID Numbers: RC31/17/0059; 2017-A02206-47 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No