Contraceptive Pills and Retinal Vascularization

NCT ID: NCT03964636

Last Updated: 2023-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-17

Study Completion Date

2022-12-01

Brief Summary

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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

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Conditions

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Combined Oral Contraceptives Intake

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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no contraceptive intake

OCT-A (optical coherence tomography)

Intervention Type 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.

combined 1st/2nd generation oral contraceptives intake

OCT-A (optical coherence tomography)

Intervention Type 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.

3rd/4th generation combined oral contraceptives intake

OCT-A (optical coherence tomography)

Intervention Type 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.

Interventions

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OCT-A (optical coherence tomography)

Included patients will have an OCT-A and will be questioned about their medical and ophthalmologic history, and their oestro-progestative contraceptive intake.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation A de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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VVR_2019_6

Identifier Type: -

Identifier Source: org_study_id

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