Validation of i-ROP DL to Detect More Than Mild ROP (NCT06109285)
Validation of i-ROP DL to Detect More Than Mild Retinopathy of Prematurity and a Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of Diagnosing Plus Disease of Premature Infants With or Without the Aid of the i-ROP DL in Telemedicine Setting
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Oregon Health and Sciences University — Portland, Oregon
Age range: 20 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Oregon Health and Sciences University — Portland, Oregon
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Retinopathy of Prematurity
- Bevacizumab Treatment For Type 1 ROP — Little Rock, Arkansas
- Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next) — La Jolla, California
- Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) — Durham, North Carolina
- Clinical and Genetic Analysis of ROP — Palo Alto, California
- Imaging Retinal Vasculature in Infant Eyes — Durham, North Carolina
Explore by condition: All Retinopathy of Prematurity clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.