Clinical and Genetic Analysis of Retinopathy of Prematurity
Oregon Health and Science University
Summary
Retinopathy of Prematurity (ROP) is a vascular disease affecting the retinas (back of the eye) of low birth weight infants. Although it can be treated effectively if diagnosed early, it continues to be a leading cause of childhood blindness in the United States and throughout the world. The investigators feel that this study will result in specific knowledge discovery about ROP, as well as general knowledge about how image-based data and genetic data can be combined to better understand clinical disease. Participants will be recruited from the neonatal intensive care unit (NICU) at OHSU, along with 4 collaborating institutions (William Beaumont Hospital, Stanford University, University of Illinois Chicago and University of Utah). Hospitalized infants who receive ROP screening examinations for routine care will be eligible for this study, and will be offered the opportunity to participate. Subjects who provide informed consent will have clinical data from routine care collected along with demographic characteristics, results from routine ROP screening examinations, presence of systemic disease or risk factors. Retinal photographs will be taken during these routine eye exams, using a commercially-available camera that has been FDA-cleared for taking pictures from retinas of premature infants. These retinal pictures do not contain any identifiable patient information, and are taken as routine standard of care. The long-term goal of this research is to establish a quantitative framework for retinopathy of prematurity (ROP) care based on clinical, imaging, genetic, and informatics principles. The investigators have previously recruited and rigorously phenotyped and genotyped a large study cohort, including implementation of a novel reference standard diagnosis; and built a world-class research consortium for image, genetic, and bioinformatics analysis.
Description
This NIH funded multi-center study began July 2011 with 8 study sites approved by their individual IRBs. Recruitment and data was conducted at the following sites: OHSU, Columbia Universtiy, Cornell College, William Beaumont Hospital, Children's Hospital LA, University of Miami, University of Illinois Chicago, Cedars Sinai Medical Center and Asociacion para Evitar la Ceguera (APEC) in Mexico City. For the competitive renewal of the grant which begins 6-01-20, the recruitment sites have been reduced to 5 which include OHSU, William Beaumont, University of Illinois Chicago, University of Utah an…
Eligibility
- Age range
- Up to 1 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * All infants hospitalized at participating Neonatal Intensive Care Units will be eligible for the study if they meet plublished criteria for requiring ROP screening examination, or if they are transferred to the study center for specialized ophthalmic care. These eligibility criteria are identical at each study center, and match what is done in standard clinical practice according to national guidelines published jointly by the American Academy of Pediatrics, American Academy of Ophthalmology, and American Associatioin for Pediatric Ophthalmology and Strabismus (AAP-AAO,…
Interventions
- OtherNo intervention administered.
Eye exams are standard of care and would be performed regardless of participation in this study.
Locations (5)
- Stanford UniversityPalo Alto, California
- University of Illinois ChicagoChicago, Illinois
- William Beaumont HospitalRoyal Oak, Michigan
- Oregon Health & Science UniversityPortland, Oregon
- University of UtahSalt Lake City, Utah