Contraceptive Pills and Retinal Vascularization (PILURET)

February 16, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Contraceptive Pills and Retinal Vascularization (Piluret)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation A De Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2019

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 28, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VVR_2019_6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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