Automated Screening Device to Detect MTMROP

Completed · Not applicable

Conditions studied: Retinopathy of Prematurity, ROP

In brief

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.

Key facts

Study ID: NCT06517836
Run by: Siloam Vision
People needed: 1284
Starts: 2024-10-20
Expected to finish: 2025-03-01
Last updated by the study team: 2025-12-18

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Oregon Health and Sciences University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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