Contraceptive Pills and Retinal Vascularization | NCT03964636

Studies
Contraceptive Pills and Retinal Vascularization

NCT03964636

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Feb 17, 2023Actual

Enrollment

51Actual

Phase

Not provided

Conditions

Combined Oral Contraceptives Intake

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 1, 2022Actual

Completion Date

Dec 1, 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 taking of combined 1st and 2nd generation or 3rd and 4th generation oral contraceptives is associated with a change in retinal micro-vascularization compared to the absence of combined oral contraceptive intake.

Women of childbearing age will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to their medical and ophthalmologic history and their oestro-progestative contraceptive intake will be collected.

The objective is to find an association between retinal vascular density and combined oral contraceptives 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

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
no contraceptive intake			Diagnostic Test: OCT-A (optical coherence tomography)
combined 1st/2nd generation oral contraceptives intake			Diagnostic Test: OCT-A (optical coherence tomography)
3rd/4th generation combined oral contraceptives intake			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 medical and ophthalmologic history, and their oestro-progestative contraceptive intake.

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 the control group : No Estro-progestin contraceptive treatment (oral, transdermal) for at least 6 months
for the cases under combined 1st and 2nd generation pills : Estro-progestin contraceptive treatment for at least 6 months
for the cases under combined 3rd and 2th generation pills: Estro-progestin contraceptive treatment for at least 6 months

Exclusion criteria:

Menopausal woman
Ametropia greater than + 3 hyperopia diopters or-3 myopia diopters
Astigmatism greater than 2 dioptres
Smoking patient (cigarette or e-cigarette)
Caffeine intake within 2 hours prior to the OCT-A exam
Any known retinal pathology
Antecedent of deep vein thrombosis or deep arterial thrombosis

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women of chilbearing age presenting to an ophthalmologic consultation at the Foundation Rothschild will be included in one of the 3 groups: no contraceptive intake, combined 1st/2nd generation oral contraceptives and 3rd/4th generation combined oral contraceptives, 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

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Browse Branches

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