Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 主要终点
- To show a difference on vascular density in OCT-A (%), between preterm children (born ≤ 28 SA) and control children (born > 38SA).
研究概览
简要总结
Retinal vascularization in humans develops between the 16th and 36th week of amenorrhea, centrifugally from the papilla. In case of premature birth, the immature retinal periphery is at risk of ischemic damage due to lack of vascular development.
Prematurity is often associated with respiratory fragility. It often requires ventilatory assistance in the form of oxygen therapy, invasive (oro-tracheal intubation) or non-invasive, which leads to reflex arteriolar vasoconstriction aggravating the ischemia already present. One may wonder if there are subclinical retinal vascular changes, detectable on Tomographie par Cohérence Optique-Angiography (, that could explain the greater risk of amblyopia and optical correction observed. Tomographie par Cohérence Optique-Angiography is a fast growing technique in retinal vascular pathologies: it is a simple, fast, reliable, non-invasive, injection-free examination, which allows to study in high resolution the retinal vascularization, with a distinct analysis of the retinal plexuses and the choriocapillaris
详细描述
Retinal vascularization in humans develops between the 16th and 36th week of amenorrhea, centrifugally from the papilla. In case of premature birth, the immature retinal periphery is at risk of ischemia due to lack of vascular development. This lack of perfusion in the retinal periphery leads to abnormal secretion of pro-angiogenic factors, promoting the appearance of abnormal neovessels, which can be complicated by intravitreal hemorrhage and tractional retinal detachment, permanently altering vision.
Conversely, it is known that in premature infants, there is a smaller central avascular zone compared to full-term infants. This area of the retina, where 90% of the cones are concentrated, must be free of vascular structures to allow optimal vision.
Prematurity is often associated with respiratory fragility. It often requires ventilatory support in the form of oxygen therapy, invasive (oro-tracheal intubation) or non-invasive, which causes reflex arteriolar vasoconstriction, aggravating the ischemia already present in the periphery.
Clinically, after birth, ocular disorders are more frequently found in preterm infants: amblyopia and contrast vision disorders, ametropia, strabismus and optic nerve anomalies.
It is questionable whether there are subclinical retinal vascular changes, detectable on Tomographie par Cohérence Optique-Angiography, associated with clinical differences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature group:
- •Any child aged 5 to 15 years born before or at 28 SA (with or without BPD), followed or not at the Creteil's hospital intercommunal
- •Control group:
- •Any child aged 5 to 15 years born ≥ 38SA, consulting ophthalmology at the Creteil 's hospital intercommunal.
- •Acceptance to participate in the protocol
- •Child living near the Creteil's intercommunal hospital
- •Affiliated to a social security system
排除标准
- •Neurobehavioral disorder or psychomotor delay that does not allow the examination to be performed
- •Presence of a POR with zone I involvement or having received IVT of anti-VEGF (as it may directly modify the OCT-A parameters)
- •Pre-existing retinal pathology: macular scarring of any etiology, retinal vascular alterations such as sickle cell disease, diabetes.
- •Pre-existing optic nerve pathologies: glaucoma, coloboma, tumors.
- •Chronic respiratory pathologies other than BPD (i.e. not associated with prematurity): cystic fibrosis, DDB...
- •General pathology unrelated to prematurity that may have a retinal impact: e.g. respiratory diseases other than BPD
- •Participation in an interventional study in ophthalmology
- •A history of hyperthermic convulsions in infants or epilepsy, which contraindicates the use of eye drops.
结局指标
主要结局
To show a difference on vascular density in OCT-A (%), between preterm children (born ≤ 28 SA) and control children (born > 38SA).
时间窗: 1day
Macular and peripapillary vascular densities (%):on OCT-A images at the superficial and deep capillary plexus in the control and preterm groups
次要结局
- To demonstrate a correlation between neonatal history (term, birth weight, duration of oxygen therapy, ventilation mode, presence or absence of BPD), clinical parameters (visual acuity, spherical equivalent), and OCT-A parameters.(1 day)
- To demonstrate differences in OCT-A parameters (central avascular zone area (mm2), between premature children (born ≤ 28 SA) and control children (born > 38SA)(1 day)
- To demonstrate differences in clinical parameters (visual acuity, spherical equivalent) between premature children (born ≤ 28 SA) and control children (born > 38SA)(1 day)
- To demonstrate differences in OCT-A parameters (fractal dimension), between premature children (born ≤ 28 SA) and control children (born > 38SA)(1 day)