1284 Participants Needed

Automated Screening for Retinopathy of Prematurity

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Siloam Vision
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Research Team

JP

John P Campbell, MD/MPH

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for babies born prematurely who are in the NICU and need screening for a serious eye condition called Retinopathy of Prematurity (ROP). The study will use images from previous research to test a new automated system.

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

My baby was in the NICU for retinopathy of prematurity that is getting better or was treated.
Major ocular or systemic congenital abnormality
Significant media opacity precluding visualization of the retina
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Image Acquisition and Analysis

Digital images are acquired by a technician and analyzed by the i-ROP DL system to detect more than mild ROP

6 months
Weekly image acquisition

Follow-up

Participants are monitored for safety and effectiveness after image analysis, with follow-up appointments scheduled based on screening results

6 months
Weekly follow-up appointments

Treatment Details

Interventions

  • iROP DL
Trial Overview The i-ROP DL system, an automated device designed to detect severe ROP in premature infants using images, is being tested. Its accuracy will be compared with standard image-based diagnoses.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: eROP dataExperimental Treatment1 Intervention

iROP DL is already approved in United States for the following indications:

🇺🇸
Approved in United States as i-ROP DL for:
  • Detection of more-than-mild retinopathy of prematurity (ROP)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Siloam Vision

Lead Sponsor

Trials
2
Recruited
1,300+

National Eye Institute (NEI)

Collaborator

Trials
572
Recruited
1,320,000+
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