TabagismTABARETNCT03964623
Impact of Nicotine on Retinal Vascularization
An observational study of Tabagism, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The main hypothesis is the nicotine is associated with a modification of retinal micro-vascularization. Patients will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to medical history, oral contraceptive intake and nicotine consumption… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tabagism
- What is being tested?
- OCT-A (Optical Coherence Tomography)
- Type of treatment
- Pill or oral medicine
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2019to 2 Dec 2022
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People presenting to an ophthalmologic consultation at the Foundation Rothschild will be included in one of the 3 groups: smokers, non-smokers/non-vapers or vapers if they meet the inclusion and non-inclusion criteria
Who may be able to join
- For group of smokers: Patient reporting active smoking for at least 3 months and at least 1 cigarette per day on average over a week
- For group of vapers : Patient using exclusively the electronic cigarette with a nicotine level of more than 6mg/ml for at least 3 months and at least 1 times per day on average over a week.
- For group of no-smokers no-vapersNon-smoking and no vaping, for more than 6 months
- Non-inclusion criteria:
- Caffeine intake within 2 hours prior to the OCT-A exam
- ametropia greater than + 3 dioptres of hyperopia or-3 dioptres of myopia
- astigmatism greater than 2 dioptres
- Known retinal or retina vascular pathology
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Nicotine on Retinal Vascularization (Tabaret)
The main hypothesis is the nicotine is associated with a modification of retinal micro-vascularization.
Patients will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to medical history, oral contraceptive intake and nicotine consumption via cigarette or e-cigarette data will be collected.
The objective is to seek an association between retinal vascular density and inhaled nicotine intake.
- Conditions
- Tabagism
- Being tested
- OCT-A (Optical Coherence Tomography)
- Keywords
- OCT-A, smokers, vapers, non-smokers/non-vapers, nicotine, retinal micro-vascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-A (Optical Coherence Tomography)Diagnostic test
Included patients will have an OCT-A and will be questioned about their nicotine intake, their background and taking an oral conception
| Study group | Role | What they receive |
|---|---|---|
| smokers | Not described Receives: Diagnostic Test: OCT-A (Optical Coherence Tomography) | |
| vapers | Not described Receives: Diagnostic Test: OCT-A (Optical Coherence Tomography) | |
| non smokers/non vapers | Not described Receives: Diagnostic Test: OCT-A (Optical Coherence Tomography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A.
Measured: At the inclusion consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start17 Jul 2019
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TabagismStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964623
- Sponsor's protocol ID
- VVR_2019_5
- Acronym
- TABARET
- Status last verified
- Feb 2023
- First submitted
- 24 May 2019
- Last updated
- 17 Feb 2023
- Results posted
- 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 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nicotine on Retinal Vascularization (Tabaret)
- ClinicalTrials.gov ID
- NCT03964623
- Acronym / sponsor ID
- TABARET / VVR_2019_5
- Conditions
- Tabagism
- Keywords
- OCT-A, smokers, vapers, non-smokers/non-vapers, nicotine, retinal micro-vascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 28 May 2019 (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 main hypothesis is the nicotine is associated with a modification of retinal micro-vascularization.
Patients will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to medical history, oral contraceptive intake and nicotine consumption via cigarette or e-cigarette data will be collected.
The objective is to seek an association between retinal vascular density and inhaled nicotine intake.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| smokers | – | Diagnostic Test: OCT-A (Optical Coherence Tomography) |
| vapers | – | Diagnostic Test: OCT-A (Optical Coherence Tomography) |
| non smokers/non vapers | – | Diagnostic Test: OCT-A (Optical Coherence Tomography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People presenting to an ophthalmologic consultation at the Foundation Rothschild will be included in one of the 3 groups: smokers, non-smokers/non-vapers or vapers if they meet the inclusion and non-inclusion criteria
Key inclusion criteria (8 listed)
- For group of smokers: Patient reporting active smoking for at least 3 months and at least 1 cigarette per day on average over a week
- For group of vapers : Patient using exclusively the electronic cigarette with a nicotine level of more than 6mg/ml for at least 3 months and at least 1 times per day on average over a week.
- For group of no-smokers no-vapersNon-smoking and no vaping, for more than 6 months
- Caffeine intake within 2 hours prior to the OCT-A exam
- ametropia greater than + 3 dioptres of hyperopia or-3 dioptres of myopia
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OCT-A (Optical Coherence Tomography)Included patients will have an OCT-A and will be questioned about their nicotine intake, their background and taking an oral conception | Diagnostic test | non smokers/non vapers, smokers, vapers |
Primary outcome
Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A.
Time frame: At the inclusion consultation
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 17 Feb 2023.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tabagism, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 8 inclusion and 0 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 17 Feb 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 France. 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?
Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A. (time frame: At the inclusion consultation). 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 17 Feb 2023.