TABARET: Impact of Nicotine on Retinal Vascularization

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Recruiting

CT.gov ID

NCT03964623

Collaborator

(none)

Enrollment

Location

41.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Tabagism	Diagnostic Test: OCT-A (Optical Coherence Tomography)

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Impact of Nicotine on Retinal Vascularization (Tabaret)

Actual Study Start Date :

Jul 17, 2019

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A. [At the inclusion consultation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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