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

T

Toulouse University Hospital

Status

Unknown

Conditions

Choroid Disease
Hypertension Ocular

Treatments

Other: Examination of pressure during the exercise
Other: Examination of pressures before stopping the exercise
Other: Examination of pressures after stopping the exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT03532867
RC31/17/0059
2017-A02206-47 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

13 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Healthy volunteers
Experimental group
Description:
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
Treatment:
Other: Examination of pressure during the exercise
Other: Examination of pressures after stopping the exercise
Other: Examination of pressures before stopping the exercise

Trial contacts and locations

1

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Central trial contact

Vincent SOLER, MD; Isabelle OLIVIER, PhD

Data sourced from clinicaltrials.gov

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