CompletedNot Applicable

Automated Screening Device to Detect MTMROP

United States1,284 participantsStarted 2024-10-20

Plain-language 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 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.

Who can participate

Age range4 Weeks – 2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

sensitivity and specificity of the i-ROP DL system

Timeframe: 6 months

Trial details

NCT IDNCT06517836

SponsorSiloam Vision

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-01

View on ClinicalTrials.gov More Retinopathy of Prematurity trials