Status:
COMPLETED
Automated Screening Device to Detect MTMROP
Lead Sponsor:
Siloam Vision
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Retinopathy of Prematurity
ROP
Eligibility:
All Genders
4-2 years
Phase:
NA
Brief Summary
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 provide...
Detailed Description
Retinopathy of prematurity is a disease that develops when babies are born prematurely, before the retina has fully developed. It is a leading cause of childhood blindness worldwide, but blindness is ...
Eligibility Criteria
Inclusion
- Eligible subjects under protocol e-ROP, defined as Infants with birth weight (BW) less than 1251 g meeting current ROP screening.
- All examinations will be eligible for inclusion regardless of the e-ROP label for image quality.
- Cases are collected during the telemedicine-based remote digital fundus imaging (RDFI-TM) evaluations.
Exclusion
- Postmenstrual age greater than 39 weeks at first opportunity for imaging unless transferred in for ROP treatment.
- Admission to a neonatal intensive care unit (NICU) with regressing or treated ROP.
- Significant media opacity precluding visualization of the retina.
- Major ocular or systemic congenital abnormality.
Key Trial Info
Start Date :
October 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
1284 Patients enrolled
Trial Details
Trial ID
NCT06517836
Start Date
October 20 2024
End Date
March 1 2025
Last Update
December 18 2025
Active Locations (1)
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1
Oregon Health and Sciences University
Portland, Oregon, United States, 97239