Clinical and Genetic Analysis of ROP

Recruiting now

Conditions studied: Retinopathy of Prematurity

In brief

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.

Key facts

Study ID

NCT04420156

Run by

Oregon Health and Science University

People needed

2000

Starts

2011-07-01

Expected to finish

2030-05-31

Last updated by the study team

2022-04-20

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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, Pediatrics, 2013).

You may not qualify if…

• Patients will be excluded if they have structural ocular anomalies, or if they are considered unstable for examintion by their attending neonatologist.

Where it is running

• University of Illinois Chicago — Chicago, Illinois, United States (enrolling)
• William Beaumont Hospital — Royal Oak, Michigan, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• Stanford University — Palo Alto, California, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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