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The Effect of Oral Contraceptive Pills On Eyes

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ClinicalTrials.gov Identifier: NCT02841202
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Yusuf MADENDAG, Kayseri Education and Research Hospital

Brief Summary:
The investigators aimed to evaluate the effect of oral contraceptive pills(OCP) on macula, retinal nerve fiber layer and choroid thickness by using Optical Coherence Tomography (OCT). The present clinical study is the first research reported in the literature which is investigating the posterior ocular segment changes in women using OCP by using OCT.

Condition or disease Intervention/treatment Phase
Adverse Effect of Oral Contraceptives, Subsequent Encounter Drug: oral contraceptive pills Phase 4

Detailed Description:
Spectral-domain optical coherence tomography (OCT) which is used to evaluate retina both qualitatively and qualitatively is a non invasive process. And also OCT makes it possible to perform retinal exams repeatedly without eye drops and dilatation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Oral Contraceptive Pills On Macula, Retinal Nerve Fiber Layer and Choroid Thickness
Study Start Date : January 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Active Comparator: oral contraceptive pills group
healthy women using oral contraceptive pills for only contraception for more than one year was called OCP group
Drug: oral contraceptive pills
Other Name: yasmin

No Intervention: control group
The second group was called control group consisting 20 healthy women and using no drug



Primary Outcome Measures :
  1. Adverse Events on Eyes That Are Related to Treatment [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All the participants in the study group were Caucasian origin and the ages of them ranged from 18 to 48 in the reproductive period

Exclusion Criteria:

  • None of the women in the study was pregnant. Women who reported histories of any medical problems such as thyroid disorders, hypertension, thromboembolic disease, diabetes mellitus, cardiovascular events, Cushing disease, positive malignancy, congenital adrenal hyperplasia, liver disease, psychotic disorders and neither did they use antidepressants nor steroidal hormone drugs and mood stabilizers (lithium, valproic acid, cocaine, antiandrogens, and insulin sensitizers, etc) were excluded from the study. Subjects were also excluded if they used caffeine or tobacco. The investigators also excluded from the study those women who had ocular surgery, ocular trauma or any ocular diseases such as glaucoma, cystoid macular edema, macular degeneration, optic atrophy, intraocular pressure 421 mmHg, cataract, best corrected visual acuity worse than 20/30, high spherical4± 3 dioptre or cylindrical42 dioptre refractive errors and uveitis at the time of OCT measurement.

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): NCT02841202


Sponsors and Collaborators
Kayseri Education and Research Hospital
Investigators
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Principal Investigator: YUSUF MADENDAG Kayseri Education and Research Hospital
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Responsible Party: Yusuf MADENDAG, obstetrics and gynecology, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT02841202    
Other Study ID Numbers: 2013/65
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: July 2016
Keywords provided by Yusuf MADENDAG, Kayseri Education and Research Hospital:
optical coherence tomography
oral contraceptive pills
Additional relevant MeSH terms:
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Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female