Purpose of this Study
We are doing this study to find out if pictures taken of the back of the eye (retina) using a special type of camera called Optical Coherence Tomography (OCT) can predict how well a baby will be able to see and how their brain works at school age.
El propósito de este estudio es determinar si las fotos tomadas del fondo de ojo (retina) usando una cámara especial que se llama Tomografía de coherencia Óptica (OCT), puede predecir la visión y como el cerebro funciona a la edad escolar.
Who Can Participate?
Eligibility
Infants or children who were born prematurely and:
- Were transferred to Duke Hospital or Duke Regional Hospital if they weren't born there
- Weighed less than 1 kilogram (2 pounds, 3 ounces) at birth
- Were born between the 20th and 29th weeks of pregnancy
- Are enrolled in the BabySTEPS1 (Pro00069721) study with consent given to be contacted for this school age follow-up study
- Que han sido trasladados al Hospital Regional de Duke en el caso que no hubieran nacido allí
- Que el peso al nacer sea menos de 1 kg (son 2 libras y 3 onzas)
- Que hayan nacido entre las semanas 20 y 29 del embarazo
- Que estén participando del estudio BabySTEPS1 (Pro00069721) donde se dio consentimiento para poder contactarlos a la edad escolar del niño/a para la cita de seguimiento
Age Range
0-50
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
Description
If your child joins this study, they will:
- Have eye images taken using OCT while they are in the nursery or in the operating room
- Possibly have other pictures taken using different cameras for comparison (RetCam, Spectralis, Optos, LENSTAR)
- Share information from their medical record
- Have information collected on the ease of imaging, infant comfort and Retinopathy of Prematurity (ROP)
- Have eye exams
- Se le tomara unas imágenes de los ojos usando OCT cuando el/ella están en la nursery o si va a la sala de cirugía
- Es posible que se tomen otras fotos con otros equipos para comparar (RetCam, Spectralis, Optos, LENSTAR)
- Se tendrá acceso a la información de la historia clínica
- Obtener información respecto al grado de dificultad de sacar las fotos, el grado de confort del niño/a y la Retinopatía de la prematurez
- Se le realizaran examines de los ojos
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 2; School Age Follow on Study
Principal Investigator
Cynthia
Toth
Protocol Number
PRO00107978
NCT ID
NCT04995341
Phase
N/A
Enrollment Status
Open to Enrollment