Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care (BabySTEPS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 4
- 主要终点
- Number of infants with reproducible imaging of the peripheral vascular-avascular junction (Aim 1B)
研究概览
简要总结
Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that may impact vision in vulnerable preterm neonates for a lifetime. This study utilizes new technology to determine visual and neurological development of very preterm infants in the intensive care nursery, during a period of rapid growth of the retina, optic nerve and brain. The long-term goal of this study is to help improve preterm infant health care via objective bedside imaging and analysis that characterizes early critical indicators of poor vision, neurological development and ROP, which will rapidly translate to better early intervention and improved future vision care.
详细描述
Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that may impact vision in vulnerable preterm neonates for a lifetime. Clinical care of infants with ROP decreases the likelihood of blindness, but abnormal vision is common, especially in those with disease severe enough to require treatment. Because it has not been possible to distinguish whether disease and/or maldevelopment that affects specific retinal cells and/or the central nervous system (CNS) cause the vision loss, especially when it is less severe, there has been no strategy to prevent subnormal acuity in the majority of infants treated for ROP.
The interval that a preterm infant at risk for ROP spends in an intensive care nursery (ICN) is a time of rapid retinal development. Clinicians and researchers do not know how local, CNS and systemic development and disease processes are reflected in the retinal microanatomy. Abnormalities in the retina during infancy are likely early predictors of later vision problems and developmental delay. From study of preterm retinal substructures, brain anatomy, connectivity and functional networks and neuroinflammatory biomarkers this study will elucidate the pathway by which local retinal anatomic changes impact and may predict later subnormal vision and CNS function. The results of this research will enable the investigator to: distinguish ocular from non-ocular contributions to vision loss; guide future treatment directed to modify retinal anomalies such as edema; and determine which microanatomic retinal biomarkers are best to monitor effects of ROP, and effects of systemic therapies on the eye and brain. In contrast to indirect ophthalmoscopy or photography, novel non-contact ocular imaging at the bedside would enable direct telemedicine screening for ROP and for neural development in multiple nurseries.
The long-term goal is to help improve preterm infant health care via objective bedside imaging and analysis that characterizes early critical indicators of poor vision, neurological development and ROP. This will rapidly translate to early intervention and improved future vision care. Specific goals of this research are threefold: to implement technological innovations to improve optical coherence tomography (OCT) imaging in non-sedated infants in the ICN; to distinguish elements of retinal microanatomy which predict maldevelopment of visual pathway and poor neurodevelopment that may impact vision in preterm infants; and to delineate which elements and regions (posterior and peripheral) of preterm infant OCT-derived retinal microanatomy best inform us about severity of disease and visual outcomes in infants with ROP.
In addition to providing a breakthrough method for bedside analysis of the very preterm (VPT) infant posterior and peripheral retina, this study will provide the pediatric ophthalmologic and telemedicine community with methods to distinguish microanatomic markers that predict infants at risk for abnormal vision, visual pathway injury, poor functional development and progression of ROP (and combinations thereof). These biomarkers will be useful for determining ophthalmic and CNS therapeutic interventions and monitoring their impact on the visual pathway and will thus likely cross over with relevance to other infant eye and brain disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Weeks 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal Guardian
- •Parent/Legal Guardian is able and willing to consent to study participation for the infant with likelihood of follow up at standard of care visits at approximately 1-month, 4-months, 9-months and 2 years corrected age
- •Infant/child undergoing clinically indicated examination under anesthesia (for the testing of the custom widefield OCT lens) that may or may not have eye pathology. (Only for Aim 1)
- •Infant meets the American Association of Pediatrics eligibility of ROP screening (Infants with a birth weight of ≤1500 g or gestational age of 30 weeks), and is age ≤ 34 6/7 weeks postmenstrual age at first visit
- •Adults (over the age of 18 years) that may or may not have eye pathology (Only for Aim *Participants in Aim 3 will not have a brain MRI, collection of scavenged blood for neuroinflammatory markers, or the neurodevelopmental 2-year visit.
排除标准
- •Participant or Parent/Legal Guardian (of infant/child) unwilling or unable to provide consent
- •Adult participant or infant/child has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peters anomaly or cataract)
- •Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly). Note that infants with brain hemorrhages and sequelae would be eligible.
结局指标
主要结局
Number of infants with reproducible imaging of the peripheral vascular-avascular junction (Aim 1B)
时间窗: 4 years
Analysis of reproducibility of imaging of the peripheral vascular-avascular junction in infants
Brain MRI grading
时间窗: 3 years
Grading and analysis of brain MRI scans collected at approximately term-equivalent age
Maximum ROP stage as determined during clinical evaluation
时间窗: 4 years
Analysis of maximum ROP stage per eye as determined during clinical evaluation
Initiate ICN research imaging with the novel ultralight hand piece and high speed SSOCT (Aim 1A)
时间窗: 4 years
Start-up of research imaging in the intensive care nursery using the new ultralight hand piece and swept source OCT
Number of microns of retinal thickness and distance from foveal to ellipsoid zone band as seen on retinal vascular imaging using infant specific automated image processing
时间窗: 3 months
Develop infant-specific automated image processing/analyses for retinal vascular imaging
Retinal microanatomy grading from Swept Source Optical Coherence Tomography (SSOCT)
时间窗: 4 years
Grading and measurement of retinal microanatomy from SSOCT images
Peripheral retinal microanatomy grading
时间窗: 4 years
Analyses of peripheral retinal microanatomy at the vascular-avascular junction as recorded via SSOCT
Number of microns of retinal thickness and distance from foveal to ellipsoid zone band as seen from multi-layer segmentation using infant specific automated image processing (1C)
时间窗: 3 months
Develop infant-specific automated image processing/analyses or multi-layer segmentation
Neurodevelopmental scores
时间窗: 3 years
Analysis of Bayley Scales-III Neurodevelopmental testing at age 2 years
Visual acuity scores
时间窗: 3 years
Analyses of data from Teller Visual acuity testing at 9 months
ROP severity grade of retinal microanatomy by OCT
时间窗: 4 years
Severity of ROP as determined by analysis of posterior and peripheral retinal microanatomy
次要结局
- ROP specifics from OCT imaging(4 years)
- Clinician's decision to treat(4 years)
- Neuroinflammatory marker scores(2 years)
- Presence of non-ROP ocular conditions(4 years)
- ROP specifics from clinical examination(4 years)
