Nicotine Influence on the Retina Following the Use of Electronic Cigarette

NCT05801419 | Completed

• 1 other identifier: ZRC07
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Electronic Cigarette Use; Retina; Change

Outcome Measures

Primary Outcomes (4)

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

  Assessed with pattern visual event-related potential (ERP)

  At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

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

  Assessed with pattern electroretinogram (pERG)

  At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

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

  Assessed with eye fundus tissue oximetry

  At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

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

  Assessed with optical coherence tomography angiography (OCT-A)

  At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline

Study Arms (1)

Baseline, post e-cigarette without nicotine and post e-cigarette with nicotine

EXPERIMENTAL

Pattern visual event-related potential (ERP) and pattern electroretinogram (pERG) on right eye (non-dilated pupil), followed by eye fundus tissue oximetry on left eye (dilated pupil), followed by optical coherence tomography angiography (OCT-A) on left eye (dilated pupil).

Device: RETI-port/scan 21; Device: Zilia Ocular; Device: OCT-A; Combination Product: Electronic cigarette without nicotine; Combination Product: Electronic cigarette with nicotine

Interventions

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.

Baseline, post e-cigarette without nicotine and post e-cigarette 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.

Baseline, post e-cigarette without nicotine and post e-cigarette 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.

Baseline, post e-cigarette without nicotine and post e-cigarette 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.

Baseline, post e-cigarette without nicotine and post e-cigarette with nicotine

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.

Baseline, post e-cigarette without nicotine and post e-cigarette with nicotine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christian Casanova: lead

Study Sites (1)

École d'optométrie de l'Université de Montréal

Montreal, Quebec, H3T 1P1, Canada

Location

MeSH Terms

Conditions

Vaping

Interventions

Electronic Nicotine Delivery Systems; Nicotine

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Christian Casanova, PhD

  École d'optométrie de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: April 6, 2023
• Study Start: August 25, 2022
• Primary Completion: November 23, 2023
• Study Completion: November 23, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)