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The Effect of Oral Contraceptive Pills On Eyes

K

Kayseri Education and Research Hospital

Status and phase

Completed
Phase 4

Conditions

Adverse Effect of Oral Contraceptives, Subsequent Encounter

Treatments

Drug: oral contraceptive pills

Study type

Interventional

Funder types

Other

Identifiers

NCT02841202
2013/65

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

18 to 48 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

oral contraceptive pills group
Active Comparator group
Description:
healthy women using oral contraceptive pills for only contraception for more than one year was called OCP group
Treatment:
Drug: oral contraceptive pills
control group
No Intervention group
Description:
The second group was called control group consisting 20 healthy women and using no drug

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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