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

Running, not enrolling · Not applicable

Conditions studied: Retinopathy of Prematurity, ROP

In brief

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.

Key facts

Study ID

NCT06109285

Run by

Siloam Vision

People needed

16

Starts

2024-06-25

Expected to finish

2026-03-01

Last updated by the study team

2025-12-17

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Oregon Health and Sciences University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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