Clinical trial Recruiting at 3 sites Observational Ages Any age to 1 Year

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.

More Retinopathy of Prematurity trials

Quick facts

Study typeObservational
AgesAny age to 1 Year
SexAll
Enrollment2000 (estimated)
SponsorOregon Health and Science University
Academic / other
Locations5 sites (Palo Alto, California and 4 other locations)
StatusRecruiting
StartedJuly 1, 2011
Main results expectedMay 31, 2024
Study endsMay 31, 2030
Registry record updatedApril 20, 2022
Trial IDNCT04420156 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

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.