Study of Changes in Retrofoveolar Choroidal Thickness During Aerobic Exercise

NCT ID: NCT03532867

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2020-07-31

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).

Conditions

Choroid Disease; Hypertension Ocular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Examination of pressures before stopping the exercise

Intervention Type: OTHER

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 exercise

Intervention Type: OTHER

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 exercise

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent SOLER, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

University Hospital Toulouse

Toulouse, , France

Countries

France

Central Contacts

Vincent SOLER, MD

Role: CONTACT

soler.v@chu-toulouse.fr

5 61 77 71 74 ext. 33

Isabelle OLIVIER, PhD

Role: CONTACT

olivier.i@chu-toulouse.fr

5 61 77 70 51 ext. 33

Facility Contacts

Vincent SOLER, MD

Role: primary

soler.v@chu-toulouse.fr

5 61 77 71 74 ext. 33

Isabelle OLIVIER, PhD

Role: backup

olivier.i@chu-toulouse.fr

5 61 77 70 51 ext. 33

Other Identifiers

2017-A02206-47

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/17/0059

Identifier Type: -

Identifier Source: org_study_id