The Effect of Oral Contraceptive Pills On Macula, Retinal Nerve Fiber Layer and Choroid Thickness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Adverse Events on Eyes That Are Related to Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All the participants in the study group were Caucasian origin and the ages of them ranged from 18 to 48 in the reproductive period
排除标准
- •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.
研究组 & 干预措施
oral contraceptive pills group
healthy women using oral contraceptive pills for only contraception for more than one year was called OCP group
干预措施: oral contraceptive pills (Drug)
结局指标
主要结局
Adverse Events on Eyes That Are Related to Treatment
时间窗: one year
次要结局
未报告次要终点
研究者
Yusuf MADENDAG
obstetrics and gynecology
Kayseri Education and Research Hospital