Impact of Nicotine on Retinal Vascularization (TABARET)

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.

Study Overview

• Status: Completed
• Conditions: Tabagism
• Intervention / Treatment: Diagnostic test: OCT-A (Optical Coherence Tomography)

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation A De Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A.	At the inclusion consultation

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): December 2, 2022
• Study Completion (Actual): December 2, 2022

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: nicotine; smokers; OCT-A; vapers; non-smokers/non-vapers; retinal micro-vascularization
• Additional Relevant MeSH Terms: Pathologic Processes; Metaplasia; Neovascularization, Pathologic
• Other Study ID Numbers: VVR_2019_5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No