PILURET: Contraceptive Pills and Retinal Vascularization
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| no contraceptive intake
|
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.
|
| combined 1st/2nd generation oral contraceptives intake
|
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.
|
| 3rd/4th generation combined oral contraceptives intake
|
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.
|
Outcome Measures
Primary Outcome Measures
- Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A. [At the inclusion consultation]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondation A de Rothschild | Paris | France | 75019 |
Sponsors and Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VVR_2019_6