Contraceptive Pills and Retinal Vascularization

Combined Oral Contraceptives Intake Clinical Trial

— PILURET  

Official title:

Contraceptive Pills and Retinal Vascularization (Piluret)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03964636
• Other study ID #: VVR_2019_6
• Status: Completed
• Start date: July 17, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Combined Oral Contraceptives Intake
• Neovascularization, Pathologic

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	Fondation A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

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