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Validation of i-ROP DL to Detect More Than Mild ROP

NCT06109285 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-12-17

No results posted yet for this study

Summary

The purpose of the pivotal reader study is to assess the readers' accuracy in diagnosing plus disease versus no plus or pre-plus disease with or without the aid of the i-ROP DL. Ophthalmologists' performance metrics for the following modalities will be evaluated:

* Standard evaluation following the standard of care process ("without i-ROP DL")
* Evaluation following the standard of care process with the aid of the i-ROP DL ("with i-ROP DL") This retrospective multi-reader multi-case (MRMC) study will have an enriched sample of approximately 300 eye cases (1 study eye per subject): 60 plus cases, 120 pre-plus cases and 120 no plus cases. Enrichment is with respect to proportions of plus cases and pre-plus cases.

The primary objective of this study is to evaluate whether the area under the receiver operating characteristic (ROC) curve (AUC) based on probability scores of plus disease statistically significantly non-inferior or superior with the aid of the i-ROP DL versus without the aid of the i-ROP DL. Multiple secondary endpoints are outlined in the next section.

Conditions

  • Retinopathy of Prematurity
  • ROP

Interventions

DEVICE

iROP DL

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).

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Siloam Vision

    lead INDUSTRY

Principal Investigators

  • John P Campbell, MD/MPH · Oregon Health and Science University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-25
Primary Completion
2026-02-01
Completion
2026-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06109285 on ClinicalTrials.gov