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OpenTrials
Completed

NCT Number: NCT05801419

Nicotine Influence on the Retina Following the Use of Electronic Cigarette

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.

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Key information

Conditions

Electronic Cigarette Use Behavior Retina; Change Smoking Vaping

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

École d'optométrie de l'Université de Montréal

Montreal, Quebec, H3T 1P1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

RETI-port/scan 21

Device

Pattern visual event-related potential and pattern electroretinogram on right eye (non-dilated pupil) at baseline, post e-cigarette vaping without nicotine and post e-cigarette vaping with nicotine.

Zilia Ocular

Device

Eye fundus tissue oximetry measure on left eye (dilated pupil) at baseline, post e-cigarette vaping without nicotine and post e-cigarette vaping with nicotine.

OCT-A

Device

Optical coherence tomography angiography measure on left eye (dilated pupil) at baseline, post e-cigarette vaping without nicotine and post e-cigarette vaping with nicotine.

Electronic cigarette without nicotine

Combination Product

Vaping using an e-cigarette paired with an e-cigarette liquid vial without nicotine. Inhaling through the mouth and exhaling through the nose ten times. Inhalations must last 5 seconds and the participant has 5 minutes to do the 10 inhalations.

Electronic cigarette with nicotine

Combination Product

Vaping using an e-cigarette paired with an e-cigarette liquid vial with nicotine. Inhaling through the mouth and exhaling through the nose ten times. Inhalations must last 5 seconds and the participant has 5 minutes to do the 10 inhalations.

Primary outcomes

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

    Time frame: At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

    Assessed with pattern visual event-related potential (ERP)

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

    Time frame: At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

    Assessed with pattern electroretinogram (pERG)

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

    Time frame: At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

    Assessed with eye fundus tissue oximetry

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

    Time frame: At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

    Assessed with optical coherence tomography angiography (OCT-A)

Sponsors and collaborators

Lead sponsor

Christian Casanova

Industry

Registry information

Official study title

Nicotine Influence on Vascularization and Retinal Metabolism Following Electronic Cigarette Use

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 6, 2023
Registry last updated
Dec 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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