Automated Screening Device to Detect MTMROP

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,284

Participants

Timeline

Start Date

October 20, 2024

Primary Completion Date

January 1, 2025

Study Completion Date

March 1, 2025

Conditions
Retinopathy of PrematurityROP
Interventions
DEVICE

iROP DL

First, to evaluate the i-ROP DL system for autonomous ROP screening. To demonstrate the sensitivity and specificity of the i-ROP DL system on images obtained by technicians in the neonatal intensive care unit (NICU) setting to detect more than mild ROP (MTMROP), defined as type 2 or worse from the Early Treatment for ROP study) compared to an image-based reference standard diagnosis (RSD).

Trial Locations (1)

97239

Oregon Health and Sciences University, Portland

All Listed Sponsors
collaborator

National Eye Institute (NEI)

NIH

lead

Siloam Vision

INDUSTRY

NCT06517836 - Automated Screening Device to Detect MTMROP | Biotech Hunter | Biotech Hunter