Clinical and Genetic Analysis of ROP
(ROP)
2 other identifiers
observational
2,000
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 20, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2030
ExpectedApril 20, 2022
April 1, 2022
12.9 years
May 20, 2020
April 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate diagnostic accuracy of an AI system for ROP diagnosis
Premature babies are examined for retinopathy of prematurity (ROP), a potentially blinding diesese. As a standard of care, retinal images are taken during ROP examinations. This research group has collected a repository of images over the past 9 years and with those images, the investigators have developed an artificial intelligence (AI) system that has the ability to diagnose severe ROP with high accuracy. The primary outcome measure in continuing to recruit subjects for this study is to collect more images to improve the existing AI system and expand the ability to diagnose ROP.
4 years
Study Arms (1)
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.
Interventions
Eye exams are standard of care and would be performed regardless of participation in this study.
Eligibility Criteria
Premature babies that are born earlier than 31 weeks gestational age or less than 1500 grams and are hospitalized at one of the 5 participating recruitment sites.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- National Institutes of Health (NIH)collaborator
- U.S. National Science Foundationcollaborator
- Massachusetts General Hospitalcollaborator
- Northeastern Universitycollaborator
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Centercollaborator
- Corewell Health Eastcollaborator
- University of Illinois at Chicagocollaborator
- Stanford Universitycollaborator
- University of Utahcollaborator
- National Eye Institute (NEI)collaborator
Study Sites (5)
Stanford University
Palo Alto, California, 94303, United States
University of Illinois Chicago
Chicago, Illinois, 60607, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Biospecimen
Blood or saliva samples were taken over the first 9 years of this study and are currently being analyzed. The study is no longer consenting subjects for dna collection.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John P Campbell, M.D.
Oregon Health and Science University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 20, 2020
First Posted
June 9, 2020
Study Start
July 1, 2011
Primary Completion
May 31, 2024
Study Completion (Estimated)
May 31, 2030
Last Updated
April 20, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Unknown at this time.
- Access Criteria
- Undetermined at this time.
All study subject data will be assigned a unique study code and recorded in a format OHSU-####, where: (a) OHSU refers to the study center that subject was recruited from (to distinguish from subjects recruited from other centers), (b) #### is a sequential number. The key to the unique study code linking the identity of the subjects will be kept in secure password protected files accessible only to authorized study personnel. De-identified data from outside sites and coded data from OHSU will be stored indefinitely in a secure IRB approved repository (7775) and may be used for future research studies. Only de-identified data will be shared with outside research collaborators.