The Effect of Oral Contraceptive Pills On Eyes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adverse Effect of Oral Contraceptives, Subsequent Encounter

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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oral contraceptive pills group

healthy women using oral contraceptive pills for only contraception for more than one year was called OCP group

Group Type ACTIVE_COMPARATOR

oral contraceptive pills

Intervention Type DRUG

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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oral contraceptive pills

Intervention Type DRUG

Other Intervention Names

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yasmin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes