Impact of Nicotine on Retinal Vascularization

Tabagism Clinical Trial

— TABARET  

Official title:

Impact of Nicotine on Retinal Vascularization (Tabaret)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964623
• Other study ID #: VVR_2019_5
• Status: Completed
• Start date: July 17, 2019
• Est. completion date: December 2, 2022

Study information

• Verified date: February 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neovascularization, Pathologic
• 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

Locations

Country	Name	City	State
France	Fondation A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A.		At the inclusion consultation