The Effect of Oral Contraceptive Pills On Eyes

NCT02841202 | Completed Phase 4

• 1 other identifier: 2013/65
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adverse Effect of Oral Contraceptives, Subsequent Encounter

Keywords

optical coherence tomography; oral contraceptive pills

Outcome Measures

Primary Outcomes (1)

• Adverse Events on Eyes That Are Related to Treatment

  one year

Study Arms (2)

oral contraceptive pills group

ACTIVE COMPARATOR

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

Drug: oral contraceptive pills

control group

NO INTERVENTION

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

Interventions

oral contraceptive pills DRUG

Also known as: yasmin

oral contraceptive pills group

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kayseri Education and Research Hospital: lead

MeSH Terms

Interventions

drospirenone and ethinyl estradiol combination

Study Officials

• YUSUF MADENDAG

  Kayseri Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: obstetrics and gynecology

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 22, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: August 21, 2017

Record last verified: 2016-07