Automated Screening for Retinopathy of Prematurity
Trial Summary
What is the purpose of this trial?
The purpose of the study is 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 healthcare providers in the neonatal intensive care unit (NICU) setting to detect more than mild ROP (MTMROP), defined as type 2 or worse (as defined by the Early Treatment for ROP \[ETROP\] study), or pre-plus, compared to an image-based reference standard diagnosis (RSD).This study will utilize a large multicenter dataset of images obtained as part of the Multicenter Telemedicine Approaches to Evaluating Acute-phase ROP (e-ROP) Study, a National Institute of Health multicenter study.
Research Team
John P Campbell, MD/MPH
Principal Investigator
Oregon Health and Science University
Eligibility Criteria
This trial is for babies born prematurely who are in the NICU and need screening for a serious eye condition called Retinopathy of Prematurity (ROP). The study will use images from previous research to test a new automated system.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Image Acquisition and Analysis
Digital images are acquired by a technician and analyzed by the i-ROP DL system to detect more than mild ROP
Follow-up
Participants are monitored for safety and effectiveness after image analysis, with follow-up appointments scheduled based on screening results
Treatment Details
Interventions
- iROP DL
iROP DL is already approved in United States for the following indications:
- Detection of more-than-mild retinopathy of prematurity (ROP)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Siloam Vision
Lead Sponsor
National Eye Institute (NEI)
Collaborator