NCT04731415尚未招募不适用
Physiologic Change of Posterior Ocular Segment During Pregnancy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Retinal vascular density
研究概览
简要总结
Women's physiology changes markedly during normal pregnancy. The most distinct alterations occur in the hormonal and cardiovascular systems. There is a dramatic increase in both estrogen and progesterone. Blood volume starts to increase in the first gestational period and reaches a peak in the third trimester.
The physiologic ocular changes during pregnancy are mainly the result of hormonal and blood volume increase, and then are usually marked in the third trimester.
详细描述
Ocular anterior segment changes during pregnancy are the followings
- Melanogenesis of eyelid and facial skin -> melasma
- Cellular alteration of lacrimal and meibomian gland -> dry eye symptoms
- Increased corneal thickness and corneal curvature -> contact lens intolerance
- Increased lens thickness -> loss of accommodation
- Decreased intraocular pressure -> better glaucoma control There are few studies of posterior changes in pregnant women. Many limitations of previous publications includes lack of internal control and no data of postpartum contraception. However, choroidal thickness seems to be thicker in pregnant women than non-pregnant women. The other changes are non-inclusive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant women
- •Age > 18 years
- •Gestational age < 12 weeks
- •Written informed consent
排除标准
- •High risk pregnancy such as multifetal pregnancy and preeclampsia
- •History of vitreoretinal diseases such as retinal vasculitis
- •History of intraocular laser treatments or intraocular surgeries
- •History of systemic diseases such as diabetes mellitus and thyroid disease
- •Refractive error; spherical equivalence > 4 diopters
- •Clear ocular media
- •Could not be taken the images by non-dilated pupil
- •Withdrawal Criteria:
- •Preterm labor; gestational age < 34 weeks
- •Multifetal pregnancy was demonstrated by ultrasound
- •Severe labor and delivery complications such as
- •Severe postpartum complications such as postpartum bleeding
- •Taking hormone during the follow-up period
结局指标
主要结局
Retinal vascular density
时间窗: 40 weeks
% of retinal vascular density is measured by optical coherence tomography angiography
次要结局
- Choroidal thickness(40 weeks)
- Retinal nerve fiber layer thickness(40 weeks)
- Optic disc tomography(40 weeks)
研究者
Suthasinee Sinawat
Associate Professor
Khon Kaen University
研究点 (2)
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