Completed

NCT Number: NCT03964636

Contraceptive Pills and Retinal Vascularization

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.

Completed

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Key information

Conditions

Combined Oral Contraceptives Intake

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondation A de Rothschild

Paris, 75019, France

Who can participate

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

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

Treatment and study plan

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.

Primary outcomes

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

Contraceptive Pills and Retinal Vascularization (Piluret)

Acronym: PILURET

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.