Electronic Cigarette UseNCT05801419
Nicotine Influence on the Retina Following the Use of Electronic Cigarette
A study testing RETI-port/scan 21, Zilia Ocular and OCT-A in people with Electronic Cigarette Use and Retina; Change, run by Christian Casanova at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Electronic Cigarette Use, Retina; Change
- What is being tested?
- RETI-port/scan 21, Zilia Ocular and OCT-A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 25 Aug 2022to 23 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
École d'optométrie de l'Université de Montréal
Montreal, Quebec, H3T 1P1
About this study
Official title: Nicotine Influence on Vascularization and Retinal Metabolism Following Electronic Cigarette Use
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.
Read more
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
- Being tested
- RETI-port/scan 21, Zilia Ocular, OCT-A, Electronic cigarette without nicotine, Electronic cigarette with nicotine
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RETI-port/scan 21Device
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 OcularDevice
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-ADevice
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 nicotineCombination 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 nicotineCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: RETI-port/scan 21; Device: Zilia Ocular; Device: OCT-A; Combination Product: Electronic cigarette without nicotine; Combination Product: Electronic cigarette with nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: At baseline, approximately 13 after baseline and after approximately 28 minutes after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start25 Aug 2022
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Casanova
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Christian Casanova, Zilia Inc.
- Investigators
- Christian Casanova, PhD, Principal investigator, École d'optométrie de l'Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801419
- Sponsor's protocol ID
- ZRC07
- Status last verified
- Dec 2023
- First submitted
- 26 Sep 2022
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Influence on Vascularization and Retinal Metabolism Following Electronic Cigarette Use
- ClinicalTrials.gov ID
- NCT05801419
- Acronym / sponsor ID
- ZRC07
- Conditions
- Electronic Cigarette Use, Retina; Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Christian CasanovaIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Baseline, post e-cigarette without nicotine and post e-cigarette with nicotine | Experimental | Device: RETI-port/scan 21, Device: Zilia Ocular, Device: OCT-A, Combination Product: Electronic cigarette without nicotine, Combination Product: Electronic cigarette with nicotinePattern 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RETI-port/scan 21Pattern 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 | Baseline, post e-cigarette without nicotine and post e-cigarette with nicotine |
| Zilia OcularEye 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 | Baseline, post e-cigarette without nicotine and post e-cigarette with nicotine |
| OCT-AOptical coherence tomography angiography measure on left eye (dilated pupil) at baseline, post e-cigarette vaping without nicotine and post e-cigarette vaping with nicotine. | Device | Baseline, post e-cigarette without nicotine and post e-cigarette with nicotine |
| Electronic cigarette without nicotineVaping 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. | Combination product | Baseline, post e-cigarette without nicotine and post e-cigarette with nicotine |
| Electronic cigarette with nicotineVaping 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. | Combination product | Baseline, post e-cigarette without nicotine and post e-cigarette with nicotine |
Primary outcome
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)
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)
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Casanova, PhD principal investigator
École d'optométrie de l'Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RETI-port/scan 21, Zilia Ocular and OCT-A in people with Electronic Cigarette Use and Retina; Change, run by Christian Casanova at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023.