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临床试验/NCT05801419
NCT05801419已完成不适用

Nicotine Influence on Vascularization and Retinal Metabolism Following Electronic Cigarette Use

Christian Casanova2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Change in retinal electric activity between baseline, after use of e-cigarette without nicotine and after use of e-cigarette with nicotine

研究概览

简要总结

The marketing of electronic cigarettes (e-cigarettes) in 2003 was initially intended to present a healthier alternative to smokers. Subsequently, it became an extremely widespread fashion phenomenon, especially among young people. It thus contributes to attracting new consumers thanks to its modern and technological presentation, combined with a panoply of captivating fragrances.

In 2014, the FDA still does not recognize this practice as a substitute for smoking intended to limit it, and several recent studies have demonstrated the potential harmful effects of e-cigarettes on health. Indeed, the latter also have pulmonary effects reminiscent of those of the original cigarette, namely breathing difficulties or even lung inflammation.

In addition, a potential impact on the vascular system has recently been highlighted by the use of these e-cigarettes. Thus, their components can lead to vascular changes in the reactivity of blood vessels, an increase in blood pressure or even endothelial dysfunction and vascular and cerebral oxidative stress.

The aim of this study is to detect these phenomena at the level of the retinal circulation, window of the central nervous system, in order to be able to confirm the acute vascular impacts of the use of an e-cigarette. In addition, the vascular and metabolic impacts due to the potential toxicity of the other components of these e-cigarettes could be investigated. Finally, the comparison between patients who are smokers and occasional smokers will provide a better understanding of the different acute and chronic effects of nicotine.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subject between 18 and 40 years old.
  • The subject must be a regular smoker (more than 1 cigarette per day for 2 years) OR be an occasional smoker (between 1 and 15 cigarettes in his life).
  • The subject must be able to sign a free and informed consent, and to follow the instructions.
  • Complete visual examination within the last 5 years.

排除标准

  • Narrow iridocorneal angles.
  • Inadequate or contraindicated pupil dilation.
  • Insufficient visual fixation.
  • Ametropia greater than -6 and +6 δ.
  • Known hypersensitivity or allergy to any component of the ophthalmic formulation used, including benzalkonium chloride (preservative) and components of the vaping liquid.
  • Eye trauma or eye surgery in the last 6 months.
  • Evidence of present or recent infection or inflammation in both eyes.
  • The use of ocular or systemic medication 30 days prior to the study.
  • Presence of ocular pathology (corneal oedema, severe keratoconjunctivitis sicca, advanced cataract, retinopathy, glaucoma).
  • Systemic disease (uncontrolled diabetes, myasthenia gravis...) or pulmonary, cardiac, hepatic, renal, endocrine problems.
  • History of epilepsy and psychiatric: schizophrenia, bipolarity, anxiety, depression.
  • Being pregnant or breastfeeding.
  • History of alcohol abuse.
  • History of drug or psychotropic use.

结局指标

主要结局

Change in retinal electric activity between baseline, after use of e-cigarette without nicotine and after use of e-cigarette with nicotine

时间窗: At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

Assessed with pattern visual event-related potential (ERP)

Change in eye fundus tissue oxygen saturation between baseline, after use of e-cigarette without nicotine and after use of e-cigarette with nicotine

时间窗: At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

Assessed with eye fundus tissue oximetry

Change in visual cortex response between baseline, after use of e-cigarette without nicotine and after use of e-cigarette with nicotine

时间窗: At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

Assessed with pattern electroretinogram (pERG)

Change in retinal capillaries density between between baseline, after use of e-cigarette without nicotine and after use of e-cigarette with nicotine

时间窗: At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

Assessed with optical coherence tomography angiography (OCT-A)

次要结局

未报告次要终点

研究者

发起方
Christian Casanova
申办方类型
Industry
责任方
Sponsor Investigator
主要研究者

Christian Casanova

Professor

Zilia Inc.

研究点 (2)

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