Contraceptive Pills and Retinal Vascularization (PILURET)

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Combined Oral Contraceptives Intake

Treatments: Diagnostic Test: OCT-A (optical coherence tomography)

Study type: Observational

Funder types: NETWORK

Identifiers

NCT03964636

VVR_2019_6

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

51 participants in 3 patient groups

no contraceptive intake

Treatment:

Diagnostic Test: OCT-A (optical coherence tomography)

combined 1st/2nd generation oral contraceptives intake

Treatment:

Diagnostic Test: OCT-A (optical coherence tomography)

3rd/4th generation combined oral contraceptives intake

Treatment:

Diagnostic Test: OCT-A (optical coherence tomography)