Clinical and Genetic Analysis of ROP

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.

Conditions

• Retinopathy of Prematurity

Interventions

OTHER

No intervention administered.

Eye exams are standard of care and would be performed regardless of participation in this study.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• U.S. National Science Foundation

  collaborator FED

• Massachusetts General Hospital

  collaborator OTHER

• Northeastern University

  collaborator OTHER

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  collaborator OTHER

• William Beaumont Hospitals

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Utah

  collaborator OTHER

• National Eye Institute (NEI)

  collaborator NIH

• Oregon Health and Science University

  lead OTHER

Principal Investigators

• John P Campbell, M.D. · Oregon Health and Science University

Eligibility

Max Age

1 Year

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-07-01

Primary Completion

2024-05-31

Completion

2030-05-31

Countries

• United States

Study Locations