Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 10:33 PM
Study NCT ID:
NCT07312669
Status:
COMPLETED
Last Update Posted:
2025-12-31
First Post:
2025-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROP Check Database Premature Infant Outcomes
Sponsor:
Alaska Blind Child Discovery
Organization:
Study Overview
Official Title:
ROP Check Premature Infant Outcomes
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observation of multi-centered care of infants covered by ROP Check cloud-based database is to compare demographic and clinical risk factors to evaluate and improve vision-protecting guidelines.
Detailed Description:
Infants from multiple academic and community hospital neonatal intensive care units (NICUs) and their covering ophthalmologists had the serial eye examination and treatment data covered by ROP Check® cloud-based database. ROP Check assists neonatologists to implement guideline scheduling of infants according to the American Academy of Pediatrics (AAP). Outcome included progression to Type 1 retinopathy of prematurity (ROP) and treatment details such as intra-vitreal anti-VEGF injection and peripheral ablative laser. demographic data including birthweight, gestational age, gender, race/ethnicity are analyzed to determine risk factors severe ROP. Blindness-preventing guidelines are reviewed, analyzed and evidence-based updates are proposed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: