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.
Who can participate
Age range
4 Weeks – 2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
sensitivity and specificity of the i-ROP DL system