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Impact of Nicotine on Retinal Vascularization (TABARET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964623
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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 via cigarette or e-cigarette data will be collected.

The objective is to seek an association between retinal vascular density and inhaled nicotine intake.


Condition or disease Intervention/treatment
Tabagism Diagnostic Test: OCT-A (Optical Coherence Tomography)

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Nicotine on Retinal Vascularization (Tabaret)
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Group/Cohort Intervention/treatment
smokers Diagnostic Test: 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

vapers Diagnostic Test: 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

non smokers/non vapers Diagnostic Test: 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




Primary Outcome Measures :
  1. Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A. [ Time Frame: At the inclusion consultation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964623


Contacts
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Contact: Vivien Vasseur +33148036437 vvasseur@for.paris
Contact: Amélie Yavchitz +33148036454 ayavchitz@for.paris

Locations
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France
Fondation A de Rothschild Recruiting
Paris, France, 75019
Contact: Vivien VASSEUR    148036440 ext +33    vvasseur@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03964623    
Other Study ID Numbers: VVR_2019_5
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
OCT-A
smokers
vapers
non-smokers/non-vapers
nicotine
retinal micro-vascularization
Additional relevant MeSH terms:
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Neovascularization, Pathologic
Metaplasia
Pathologic Processes