Automated Screening Device to Detect MTMROP

NCT06517836 | Completed DMC FDA Device

• 2 other identifiers: SVCT-0021R44EY035596-01
• Study Type: interventional
• Target: 1,284
• Locations: 1 country
• Sites: 1

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 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.

Conditions

ROP; Retinopathy of Prematurity

Keywords

Retinopathy of Prematurity; ROP

Outcome Measures

Primary Outcomes (1)

• sensitivity and specificity of the i-ROP DL system

  sensitivity and specificity of the I-ROP DL system for more than mild ROP and treatment requiring (type 1) ROP

  6 months

Study Arms (1)

eROP data

EXPERIMENTAL

Device: iROP DL

Interventions

iROP DL DEVICE

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).

eROP data

Eligibility Criteria

• Age: 4 Weeks - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.
• 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.

Sponsors & Collaborators

• Siloam Vision: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Oregon Health and Sciences University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• John P Campbell, MD/MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: October 20, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)