Status:
RECRUITING
Clinical and Genetic Analysis of ROP
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
National Institutes of Health (NIH)
U.S. National Science Foundation
Conditions:
Retinopathy of Prematurity
Eligibility:
All Genders
Up to 1 years
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 b...
Detailed Description
This NIH funded multi-center study began July 2011 with 8 study sites approved by their individual IRBs. Recruitment and data was conducted at the following sites: OHSU, Columbia Universtiy, Cornell C...
Eligibility Criteria
Inclusion
- 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
- Patients will be excluded if they have structural ocular anomalies, or if they are considered unstable for examintion by their attending neonatologist.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2030
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04420156
Start Date
July 1 2011
End Date
May 31 2030
Last Update
April 20 2022
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Palo Alto, California, United States, 94303
2
University of Illinois Chicago
Chicago, Illinois, United States, 60607
3
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
4
Oregon Health & Science University
Portland, Oregon, United States, 97239