Nicotine Influence on the Retina Following the Use of Electronic Cigarette

Electronic Cigarette Use Clinical Trial

Official title:

Nicotine Influence on Vascularization and Retinal Metabolism Following Electronic Cigarette Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05801419
• Other study ID #: ZRC07
• Status: Completed
• Phase: N/A
• Start date: August 25, 2022
• Est. completion date: November 23, 2023

Study information

• Verified date: December 2023
• Source: Zilia Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 23, 2023
• Est. primary completion date: November 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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 d.
• 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.

Related Conditions & MeSH terms

• Electronic Cigarette Use
• Retina; Change

Intervention

Device:
• RETI-port/scan 21
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
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
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.

Combination Product:
• Electronic cigarette without nicotine
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
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.

Locations

Country	Name	City	State
Canada	École d'optométrie de l'Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Christian Casanova

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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