Nicotine Influence on the Retina Following the Use of Electronic Cigarette

Sponsor
Christian Casanova (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05801419
Collaborator
(none)
44
1
1
10.2
4.3

Study Details

Study Description

Brief Summary

The marketing of electronic 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 electronic cigarette. In addition, the vascular and metabolic impacts due to the potential toxicity of the other components of these electronic 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.

Condition or Disease Intervention/Treatment Phase
  • Device: RETI-port/scan 21
  • Device: Zilia Ocular
  • Device: OCT-A
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
44 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Nicotine Influence on Vascularization and Retinal Metabolism Following Electronic Cigarette Use
Actual Study Start Date :
Aug 25, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Baseline, post electronic cigarette without nicotine and post electronic cigarette with nicotine

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
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.

Device: 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.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Change in retinal electric activity between baseline, after use of e-cigarette without nicotine and after use of e-cigarette with nicotine [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 [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 [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 [At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline]

    Assessed with optical coherence tomography angiography (OCT-A)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 École d'optométrie de l'Université de Montréal Montréal Quebec Canada H3T 1P1

Sponsors and Collaborators

  • Christian Casanova

Investigators

  • Principal Investigator: Christian Casanova, PhD, École d'optométrie de l'Université de Montréal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christian Casanova, Professor, Zilia Inc.
ClinicalTrials.gov Identifier:
NCT05801419
Other Study ID Numbers:
  • ZRC07
First Posted:
Apr 6, 2023
Last Update Posted:
Apr 6, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Apr 6, 2023