Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 2 and School Age Follow on Study (BabySTEPS2)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 236
- 试验地点
- 4
- 主要终点
- Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading (Cohort 1-3)
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 can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants in the intensive care nursery, to characterize previously unseen abnormalities that can predict a need for referral for ROP treatment, or poor visual or neurological development later in life, up to pre-school age. Our long-term goal is to help improve preterm infant health and vision via objective bedside imaging and analysis that characterizes early critical indicators of ROP, and poor visual function and neurological development, which will rapidly translate to better early intervention and improved future care.
详细描述
As an increasing percentage of preterm infants survive worldwide, the number of infants at risk for retinopathy of prematurity (ROP) is increasing. These infants are also at high risk for future abnormal visual function and neurodevelopment. While current screening approaches address identifying eyes for treatment of severe ROP, there are no attempts to address the later subnormal vision of many preterm infants. In part, this is due to a lack of information about the retina beyond that of retinal vascular development. In addition, the most common method to screen for ROP remains indirect ophthalmoscopic examination by physicians with annotated drawings for documentation, a method proven to be poorly reproducible and stressful to the fragile infant. Bedside retinal photographs enable documentation and the possibility for telemedicine approaches, but lack information about retinal microanatomy, are poor quality in darkly pigmented eyes and also are stressful to the infant because of the required light exposure. We need an infant-friendly, more practical approach to evaluate ROP efficiently and additional information about ocular and neurovascular development that could lead to improved clinical care.
This research builds on our group's ability to reliably capture and process non-contact, infrared optical coherence tomography (OCT) and OCT-angiography of retinal microanatomy and microvasculature at high speed, across a wide field of view, and at the bedside in preterm infants. Our overall objectives are threefold: first, to evaluate infant microanatomy and microvascular flow findings relevant to vision and neurodevelopmental outcomes in children; second, to translate and test our imaging achievements for real-world use by nurses at the bedside and for better clinical insight and feedback; and third, to gather additional data in eyes that progress to treatment and dive deeper into the insight that they provide into pathways of disease in ROP. The investigational OCT imaging will be used in this research to gather information that is otherwise not accessible to the physician. This research will lay the groundwork for future use of infant OCT markers to guide care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
While all participants have the investigational imaging, throughout image grading, the principal investigator and image analysts are masked to all health data (including retinopathy of prematurity examination findings) except age at time of imaging. The visual acuity and neurodevelopmental outcome assessors are masked to all OCT image and fundus photograph grading data.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children previously enrolled in BabySTEPS1 (Pro00069721) that have already consented to being contacted for this school age follow on study, Cohort 1 only
- •Parent/Legal Guardian is able and willing to consent to study participation with follow up approximately between 4.5 and 5 years of age (consent available in Spanish* and English) (SA 1 only)
- •Parent/Legal Guardian is able and willing to consent to study participation for the infant (SA 2 and 2c only)
- •Infant/child undergoing clinically-indicated examination under anesthesia that may or may not have eye pathology (SA 2 only)
- •Infant inborn or outborn at (SA 2 only):
- •Duke Hospital (Years 1, 2 and 3) with birth weight ≤1000 grams, and/or 20 0/7 to 28/ 6/7 (<29 weeks) gestational age
- •Duke Hospital (Years 1, 2 and 3) at high risk to require treatment for ROP irrespective of birth weight and gestational age (e.g. pre-plus, severe ROP in zone 1, APROP, etc.)
- •Duke Regional Hospital (Years 4 and 5) that meets the American Association of Pediatrics eligibility of ROP screening (Infants with a birth weight of ≤1500 g or gestational age of 30 weeks)
- •Adults (over the age of 18 years) that may or may not have eye pathology (SA 2 only)
排除标准
- •Participant or Parent/Legal Guardian 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 Peter's anomaly or cataract) (SA2 only)
- •Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly) (SA2 only)
研究组 & 干预措施
Cohort 1: Functional and structural outcomes in children after bedside OCT imaging in infancy
109 pediatric participants who were previously enrolled in BabySTEPS1 from July 22, 2016 - December 30, 2020 will be enrolled for follow-up neurodevelopmental testing, visual acuity, visual function testing and investigational retinal imaging
干预措施: Investigational ultracompact OCT and OCTA system (Device)
Cohort 2: Test of bedside OCT imaging data to predict RW-ROP or ROP progression
294 infants at risk for retinopathy of prematurity: 176 will be enrolled and have investigational bedside OCT retinal imaging, and their data will be combined with that from 118 infants who had similar imaging in BabySTEPS1 for analysis of the total group versus the indirect ophthalmoscopic clinical exam data.
干预措施: Investigational ultracompact OCT and OCTA system (Device)
Cohort 3: Comparison of ROP imaging with investigational OCT versus retinal camera
102 infants, who are a sub-group of the 132 enrolled in Cohort 2, will also have imaging with a conventional, commercially available, retinal camera system to compare utility, stress, and prediction and documentation of referral-warranted ROP between the camera images and those from investigational OCT.
干预措施: Investigational ultracompact OCT and OCTA system (Device)
Cohort 3: Comparison of ROP imaging with investigational OCT versus retinal camera
102 infants, who are a sub-group of the 132 enrolled in Cohort 2, will also have imaging with a conventional, commercially available, retinal camera system to compare utility, stress, and prediction and documentation of referral-warranted ROP between the camera images and those from investigational OCT.
干预措施: retinal photographs (Device)
Cohort 4: Adult and pediatric participants enrolled for imaging during system development
12 awake healthy adult controls and 6 pediatric participants undergoing examination under anesthesia in the operating room will be imaged with the investigational bedside OCT for the purpose of technological development.
干预措施: Investigational ultracompact OCT and OCTA system (Device)
结局指标
主要结局
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading (Cohort 1-3)
时间窗: Up to 42 weeks post-menstrual age
Retinal thickness (microns) at the fovea and surrounding optic nerve.
Assessment of ease of imaging (Cohort 3 only)
时间窗: Up to 42 weeks post-menstrual age
Based on Likert scales (1-5)
Visual function scores (Cohort 1 only)
时间窗: 4.75-year study visit
Visual function at the 4.75-year visit is measured by the presence or absence of strabismus, nystagmus, and amblyopia
Optotype Visual acuity scores (Cohort 1 only)
时间窗: 5-year study visit
HOTV visual acuity at the 5-year study visit. Visual acuity is recorded as the last line of the HOTV chart on which over 50% of the 4 symbols are identified correctly identified by the participant. If the participant is not capable of performing HOTV, then Teller cards will be used for preferential-looking visual acuity assessment. With Teller, acuity is determined by the smallest cycles per degree.
Neurodevelopmental scores at 2-year study visit (Cohort 1 only)
时间窗: 2-year study visit
Neurodevelopmental testing at the 2-year neurodevelopment study visit: a) Bayley Scales of Infant and Toddler Development: Scores motor skills with the standardized mean motor score of 100; less than 85 indicates mild impairment; less than 70 indicates moderate to severe impairment.
Microanatomy as measured by OCT reading
时间窗: Up to 42 weeks post-menstrual age
Combination of presence and severity of: retinal vessel tortuosity, vascular abnormality score by OCT (VASO), aggressive ROP, extra retinal neovascularization, vitreous abnormalities, shunt vessels, retinoschisis and retinal detachment.
ROP vascular severity score (Cohort 3 only)
时间窗: Up to 42 weeks post-menstrual age
Based on a combination of relative retinal vessel tortuosity score, extraretinal neovascularization and aggressive ROP.
Microanatomy as measured by retinal photo reading (Cohort 3 only)
时间窗: Up 42 weeks post-menstrual age
Combination of presence and severity of retinal vessel tortuosity, aggressive ROP, extra retinal neovascularization, shunt vessels, vitreous opacities, vitreous haze, retinoschisis and retinal detachment.
Microanatomy as measured by clinical exam (Cohort 1-3)
时间窗: Up to 42 weeks post-menstrual age
Clinical determination of combination presence and severity of retinal vessel tortuosity, aggressive ROP, extra retinal neovascularization, shunt vessels, vitreous opacities, vitreous haze, retinoschisis and retinal detachment.
Measurement of stress of imaging (Cohort 3 only)
时间窗: Up to 42 weeks post-menstrual age
Assessment of stress and discomfort using modified CRIES score (crying 0-4; facial expression 0-2; heart rate beats per minute; change in respiratory support) during each eye imaging and compared to baseline pre-imaging score adverse events recorded during imaging (bradycardia, tachycardia, desaturation, emesis, and ocular adverse events e.g. conjunctival hemorrhage)
次要结局
- Neurodevelopmental scores at 5-year study visit (Cohort 1 only)(5-year study visit)
- Neurodevelopmental parental questionnaires at 5-year study visit (Cohort 1 only)(5-year study visit)