Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Choroidal thickness
研究概览
简要总结
The purpose of this study is to evaluate choroidal thickness and volume during the third trimester of pregnancy by comparison with a group of age-matched non-pregnant healthy group of women
详细描述
Pregnant women in the last trimester and age-matched healthy controls have an Optical Coherence Tomography (OCT) image taken on the OCT Spectralis® device.
A map of the choroid in the macular area is constructed automatically. Choroidal thickness and volume are calculated for the 9 subfields defined by the Early Treatment Diabetic Retinopathy Study (ETDRS).
A comparative analysis between the two groups will be performed. As a secondary outcome measure, the change in choroidal thickness of the pregnant group of women will be assessed at 6 months postpartum by comparison to the 3rd trimester of pregnancy.
The OCT is a non-invasive examination that poses no risk to the mother or the fetus.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women:
- •uncomplicated pregnancy in the third trimester (from 28 weeks of gestation)
- •For both groups:
- •no systemic or ocular disease
- •absence of systemic medication other than prenatal vitamins
- •no smoking habits
- •emmetropia or a small refractive error (spherical equivalent <1.5 diopters)
排除标准
- •any of the above
结局指标
主要结局
Choroidal thickness
时间窗: 3rd trimester of pregnancy (from 28 weeks gestation to delivery)
Comparison of choroidal thickness between the pregnant group of women and the age-matched group of control subjects
次要结局
- Change in choroidal thickness(During the 3rd trimester (from 28 weeks gestation to delivery) and at 6 months post partum)
研究者
Renata Rothwell
Dr
Gaia Hospital