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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

Tracking Information
First Submitted Date May 24, 2019
First Posted Date May 28, 2019
Last Update Posted Date July 22, 2020
Actual Study Start Date July 17, 2019
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2019)
Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A. [ Time Frame: At the inclusion consultation ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Nicotine on Retinal Vascularization
Official Title Impact of Nicotine on Retinal Vascularization (Tabaret)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Tabagism
Intervention 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
Study Groups/Cohorts
  • smokers
    Intervention: Diagnostic Test: OCT-A (Optical Coherence Tomography)
  • vapers
    Intervention: Diagnostic Test: OCT-A (Optical Coherence Tomography)
  • non smokers/non vapers
    Intervention: Diagnostic Test: OCT-A (Optical Coherence Tomography)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 24, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Vivien Vasseur +33148036437 vvasseur@for.paris
Contact: Amélie Yavchitz +33148036454 ayavchitz@for.paris
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03964623
Other Study ID Numbers VVR_2019_5
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Collaborators Not Provided
Investigators Not Provided
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date July 2020