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Validation of i-ROP DL to Detect More Than Mild ROP
NCT06109285 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DEVICE iROP DL
Study Locations (1)
Oregon
- Oregon Health and Sciences University — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-06-25 |
| Est. Completion | 2026-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06109285
The ClinicalTrials.gov registry entry for NCT06109285 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Siloam Vision, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Retinopathy of Prematurity appearing as the primary indexed condition, and to 1 intervention — of which iROP DL is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06109285 reports 1 study location spanning 1 distinct geographic area — top geographies include Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06109285 about?
NCT06109285 is a clinical study titled "Validation of i-ROP DL to Detect More Than Mild ROP". 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...
What is the current status of trial NCT06109285?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 16 participants. The study started on 2024-06-25. Estimated completion is 2026-03-01.
What conditions does trial NCT06109285 study?
This clinical trial studies the following conditions: Retinopathy of Prematurity, ROP. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06109285?
The interventions under investigation include: iROP DL (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06109285?
This trial is sponsored by Siloam Vision, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06109285 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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