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OpenTrials
Completed

NCT Number: NCT03964623

Impact of Nicotine on Retinal Vascularization

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.

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Key information

Conditions

Tabagism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondation A de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: At the inclusion consultation

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

Impact of Nicotine on Retinal Vascularization (Tabaret)

Acronym: TABARET

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 28, 2019
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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