Impact of Nicotine on Retinal Vascularization | NCT03964623

Studies
Impact of Nicotine on Retinal Vascularization

NCT03964623

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Feb 17, 2023Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Tabagism

Interventions

OCT-A (Optical Coherence Tomography)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2019Actual

Primary Completion Date

Dec 2, 2022Actual

Completion Date

Dec 2, 2022Actual

First Submitted Date

May 24, 2019

First Submission Date that Met QC Criteria

May 24, 2019

First Posted Date

May 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2023

Last Update Posted Date

Feb 17, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Fondation A de Rothschild		Paris		75019	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence

Ancestor Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

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Browse Branches

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