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

NCT06109285 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 25901R44EY035596
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

ROP; Retinopathy of Prematurity

Keywords

Retinopathy of Prematurity; ROP

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of I-ROP DL for mtmROP

  The primary endpoint of the study will be the sensitivity and specificity of the i-ROP DL system for more than mild ROP.

  6 months

Secondary Outcomes (1)

• Sensitivity and specificity of the I-ROP DL system for TR-ROP

  6 months

Study Arms (1)

Reader Study

EXPERIMENTAL

Vascular Severity Score Provided on second reading

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).

Reader Study

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• U.S. board-eligible/board-certified and licensed Medical Doctor, Doctor of Ophthalmology. (American Board of Ophthalmology or equivalent certification)
• Signed reader study agreement.
• Signed informed consent.
• Successful training on the study protocol and the use of the study software

You may not qualify if:

• Non - U.S. board-eligible/board-certified and licensed Medical Doctor, Doctor of Ophthalmology. (American Board of Ophthalmology or equivalent certification)
• Did not sign reader study agreement.
• Did not sign informed consent.
• Did not successfully complete training on the study protocol and the use of the study software

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: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 31, 2023
• Study Start: June 25, 2024
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)