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临床试验/NCT03532867
NCT03532867Unknown不适用

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

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
13
试验地点
2
主要终点
Measurement of macular choroidal thickness before, during and after standardized aerobic exercise inducing a standardized increase in arterial systolic pressure

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

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

干预措施: Examination of pressures before stopping the exercise (Other)

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

干预措施: Examination of pressure during the exercise (Other)

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

干预措施: Examination of pressures after stopping the exercise (Other)

结局指标

主要结局

Measurement of macular choroidal thickness before, during and after standardized aerobic exercise inducing a standardized increase in arterial systolic pressure

时间窗: 1 day

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.

次要结局

  • Analysis of the retinal vascular caliber on the infrared image of the OCT(2 hours (during the consultation))
  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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