Study of Changes in Retrofoveolar Choroidal Thickness During Aerobic Exercise

NCT03532867 | Unknown

• 2 other identifiers: RC31/17/00592017-A02206-47
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Choroid Disease; Hypertension Ocular

Keywords

Exercise Test; Blood Pressure; Choroid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Measurement of systolic and diastolic blood pressure

  2 hours (during the consultation)

• Measurement of intraocular pressure

  2 hours (during the consultation)

• Analysis of the peripapillary choroid in OCT

  2 hours (during the consultation)

• Analysis of the retinal vascular caliber on the infrared image of the OCT

  2 hours (during the consultation)

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

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

Interventions

Examination of pressures before stopping the exercise 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.

Healthy volunteers

Examination of pressure during the exercise 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.

Healthy volunteers

Examination of pressures after stopping the exercise 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.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Choroid Diseases; Ocular Hypertension

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Vincent SOLER, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent SOLER, MD

CONTACT

5 61 77 71 74; soler.v@chu-toulouse.fr

Isabelle OLIVIER, PhD

CONTACT

5 61 77 70 51; olivier.i@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 22, 2018
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)