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

Primary Purpose

Choroid Disease, Hypertension Ocular

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Examination of pressures before stopping the exercise
Examination of pressure during the exercise
Examination of pressures after stopping the exercise
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Choroid Disease focused on measuring Exercise Test, Blood Pressure, Choroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healthy volunteers

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
April 16, 2018
Last Updated
April 16, 2019
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03532867
Brief Title
Study of Changes in Retrofoveolar Choroidal Thickness During Aerobic Exercise
Acronym
MOPAS
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2019 (Anticipated)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroid Disease, Hypertension Ocular
Keywords
Exercise Test, Blood Pressure, Choroid

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Examination of pressures before stopping the exercise
Intervention Description
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
Intervention Name(s)
Examination of pressure during the exercise
Intervention Description
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
Intervention Name(s)
Examination of pressures after stopping the exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of macular choroidal thickness before, during and after standardized aerobic exercise inducing a standardized increase in arterial systolic pressure
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Measurement of systolic and diastolic blood pressure
Description
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.
Time Frame
2 hours (during the consultation)
Title
Measurement of intraocular pressure
Description
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.
Time Frame
2 hours (during the consultation)
Title
Analysis of the peripapillary choroid in OCT
Description
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.
Time Frame
2 hours (during the consultation)
Title
Analysis of the retinal vascular caliber on the infrared image of the OCT
Description
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.
Time Frame
2 hours (during the consultation)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent SOLER, MD
Phone
5 61 77 71 74
Ext
33
Email
soler.v@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle OLIVIER, PhD
Phone
5 61 77 70 51
Ext
33
Email
olivier.i@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent SOLER, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent SOLER, MD
Phone
5 61 77 71 74
Ext
33
Email
soler.v@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Isabelle OLIVIER, PhD
Phone
5 61 77 70 51
Ext
33
Email
olivier.i@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Changes in Retrofoveolar Choroidal Thickness During Aerobic Exercise

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