Analyzing clinical and genetic factors in Retinopathy of Prematurity
Official title: Clinical and Genetic Analysis of Retinopathy of Prematurity
Run by Oregon Health and Science University · NCT04420156 · Data updated 2026-11-12
This study is trying to see if combining clinical and genetic information can help improve the care and diagnosis of Retinopathy of Prematurity in low birth weight infants using artificial intelligence.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 1 Year |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 5 sites (Palo Alto, California and 4 other locations) |
| Status | Recruiting |
| Started | July 1, 2011 |
| Main results expected | May 31, 2024 |
| Study ends | May 31, 2030 |
| Registry record updated | April 20, 2022 |
| Trial ID | NCT04420156 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are hospitalized infants in NICUs who require ROP screening examinations.
✕Probably not a fit
Patients with structural ocular anomalies or those deemed unstable for examination by their neonatologist may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on Retinopathy of Prematurity (ROP), a condition affecting the retinas of low birth weight infants. It aims to combine clinical and genetic data to enhance understanding and management of ROP through artificial intelligence and analytics. Participants will be recruited from neonatal intensive care units across five collaborating institutions, where they will undergo routine ROP screening and have retinal images collected for analysis. The study seeks to develop a quantitative framework for ROP care and evaluate the accuracy of AI systems in diagnosing and screening this condition.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of Retinopathy of Prematurity, potentially reducing childhood blindness.
How similar studies have gone: Other studies have shown promise in using AI for medical diagnostics, suggesting potential success for this approach in ROP.
Who can join: the full rules
Show full inclusion / exclusion criteria
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, Pediatrics, 2013). Exclusion Criteria: * Patients will be excluded if they have structural ocular anomalies, or if they are considered unstable for examintion by their attending neonatologist.
Where it's running
-
University of Illinois Chicago
Chicago, Illinois, United States Recruiting -
William Beaumont Hospital
Royal Oak, Michigan, United States Recruiting -
Oregon Health & Science University
Portland, Oregon, United States Recruiting -
Stanford University
Palo Alto, California, United States Not yet recruiting -
University of Utah
Salt Lake City, Utah, United States Not yet recruiting
Study contacts
- Principal investigator: John P Campbell, M.D. — Oregon Health and Science University
- Study coordinator: John P Campbell, M.D.
- Email: campbelp@ohsu.edu
- Phone: 503-494-7891
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.