Contraceptive Pills and Retinal Vascularization

NCT03964636 | Completed

• 1 other identifier: VVR_2019_6
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Combined Oral Contraceptives Intake

Keywords

OCT-A; combined oral contraceptives

Outcome Measures

Primary Outcomes (1)

• Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A.

  At the inclusion consultation

Study Arms (3)

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

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.

3rd/4th generation combined oral contraceptives intake; combined 1st/2nd generation oral contraceptives intake; no contraceptive intake

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 28, 2019
• Study Start: July 17, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)