Retinal Nerve Fiber Layer and Macular Thickness Changes During Pregnancy by Optical Coherence Tomography: Prospective, Observational, Nonrandomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Retinal nerve fiber layer(RNFL) and Macular thickness by Optical coherence tomography(OCT) during pregnancy
研究概览
简要总结
Purpose:
Primary: to prospectively measure Retinal Nerve Fiber Layer (RNFL) and macular thickness changes during pregnancy by Optical coherence tomography
Secondary: The effect of pregnancy abnormalities on RNFL and macular thickness in participants who develop systemic or ocular complications during the study period.
详细描述
There are several known ophthalmic physiologic changes in pregnancy:
- Refractive Change: progesterone-mediated changes in fluid content partially accounts for refractive change of lens and cornea; myopic shift of less than 1 D was observed in in 15% of participating pregnant women
- Night vision decreased mainly with low serum vitamin A levels in pregnant women.
- Fall of the IOP in second half of pregnancy (about 10% drop)
- Corneal changes (increased thickness; decreased sensitivity) = contact lens intolerance
The retina and optic nerve are considered part of central nervous system, the retina and choroid are highly vascularized. Due to changes in CSF and brain volume, vascular and fluid changes all over the pregnant woman's body we expect to find changes in RNFL and macular thickness during pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1st trimester (6-14w) pregnant healthy women
- •No known medical problems related to their current pregnancy on recruitment
- •Age 18-45yrs
- •No known retinal or optic nerve disease
- •Refraction between +3.0 and -4.0 diopters
- •Agrees to participate in the study
排除标准
- •Retinal or optic nerve disease
- •Refractive errors more than +3.0 and -4.
- •If already finished 14w gestation when recruited to the 1st OCT examination
- •Known to have HTN or DM before gestation
- •Ocular media abnormality that obscures OCT view or examination
结局指标
主要结局
Retinal nerve fiber layer(RNFL) and Macular thickness by Optical coherence tomography(OCT) during pregnancy
时间窗: 1 year
The RNFL, measured in micrometers, will be followed up during the study. Every trimester (starting at the 1st trimester) an OCT will be performed measuring the thickness of the RNFL. An OCT will be performed 3 months postpartum as a control. The Macular thickness will be measured in the same manner.
次要结局
- Effect of systemic and ocular diseases on Retinal Fiber Layer and Macula during pregnancy(1 year)