Impact of Nicotine on Retinal Vascularization

NCT03964623 | Completed

• 1 other identifier: VVR_2019_5
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Tabagism

Keywords

OCT-A; smokers; vapers; non-smokers/non-vapers; nicotine; retinal micro-vascularization

Outcome Measures

Primary Outcomes (1)

• Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A.

  At the inclusion consultation

Study Arms (3)

smokers

Diagnostic Test: OCT-A (Optical Coherence Tomography)

vapers

Diagnostic Test: OCT-A (Optical Coherence Tomography)

non smokers/non vapers

Diagnostic Test: OCT-A (Optical Coherence Tomography)

Interventions

OCT-A (Optical Coherence Tomography) DIAGNOSTIC_TEST

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; smokers; vapers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 28, 2019
• Study Start: July 17, 2019
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)