Clinical and Genetic Analysis of ROP

Conditions

• Retinopathy of Prematurity

Eligibility Criteria

Sex

ALL

Age

N/A - 1 Year

Healthy Volunteers

Accepted

Interventions

• No intervention administered. — OTHER
  Eye exams are standard of care and would be performed regardless of participation in this study.

Study Details

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 Dates

Start date

Jul 1, 2011

Status verified

Apr 2022

Primary completion

May 31, 2024

Completion

May 31, 2030

Study Design

Enrollment

2,000 participants (estimated)

Arms

• Arm: i-ROP cohort
  Premature infants who are at risk of retinopathy of prematurity(ROP) at participating study sites. As standard of care, babies who are born less than 31 weeks gestational age or less than 1500 grams are routinely screened for ROP. Families are approached to participate in this study where finding from babies' eye exams and associated retinal images along with demographic and other health data are collected and coded with unique identifier. No intervention is administered. The ROP exams and images obtained are done as a standard of care and would be performed even if there is no consent provided.

Primary Outcome Measure

Evaluate diagnostic accuracy of an AI system for ROP diagnosis [ Time Frame: 4 years ]

Central Contacts

• John P Campbell, M.D.
  503-494-7891
  [email protected]
• Susan R Ostmo, M.S.
  503-494-7450
  [email protected]

Locations (5)

Find similar trials in Palo Alto, CA

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