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NCT06109285 · ClinicalTrials.gov registry record · NA
Validation of i-ROP DL to Detect More Than Mild ROP
A NA study of Retinopathy of Prematurity and ROP, sponsored by Siloam Vision.
- Active
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06109285: Active NA study of Retinopathy of Prematurity and ROP, sponsored by Siloam Vision.
NCT06109285 is a NA study of Retinopathy of Prematurity and ROP that is active but no longer recruiting, run by Siloam Vision. The registered enrollment target is 16 participants, below the 367-participant average among 7 other Retinopathy of Prematurity trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06109285, a NA study of Retinopathy of Prematurity and ROP, is active but no longer recruiting, sponsored by Siloam Vision.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary endpoint of the study will be the sensitivity and specificity of the i-ROP DL system for more than mild ROP.
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 |
What the registry record for NCT06109285 still lists
NCT06109285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 367-participant average among 7 other Retinopathy of Prematurity trials with a reported enrollment target (96% lower).
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.
NCT06109285 reports a single indexed study location in Oregon.
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.
What interventions are being tested in trial NCT06109285?
The interventions under investigation include: iROP DL (DEVICE).
Who is sponsoring clinical trial NCT06109285?
This trial is sponsored by Siloam Vision, which has 2 total clinical trials registered on ClinicalTrials.gov.
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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