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Contraceptive Pills and Retinal Vascularization (PILURET)

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ClinicalTrials.gov Identifier: NCT03964636
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

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
Combined Oral Contraceptives Intake Diagnostic Test: OCT-A (optical coherence tomography)

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Contraceptive Pills and Retinal Vascularization (Piluret)
Actual Study Start Date : July 17, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Group/Cohort 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.




Primary Outcome Measures :
  1. Density of retinal vascular Plexus (quantitative variable expressed as a percentage) using OCT-A. [ Time Frame: At the inclusion consultation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964636


Contacts
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Contact: Vivien Vasseur +33148036440 vvasseur@for.paris
Contact: Amélie Yavchitz +33148036454 ayavchitz@for.paris

Locations
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France
Fondation A de Rothschild Recruiting
Paris, France, 75019
Contact: Vivien VASSEUR    148036440 ext +33    vvasseur@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03964636    
Other Study ID Numbers: VVR_2019_6
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
OCT-A
combined oral contraceptives
Additional relevant MeSH terms:
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Neovascularization, Pathologic
Metaplasia
Pathologic Processes