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AI Screening Device

Reader Study for Retinopathy of Prematurity

N/A
Recruiting
Led By John P Campbell, MD/MPH
Research Sponsored by Siloam Vision
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial aims to improve the image acquisition and processing pipeline for FDA approval. The researchers will evaluate how image quality and field of view affect the device's output and will assess the impact of different camera operators

Who is the study for?
This trial is for U.S. board-eligible or certified ophthalmologists who have signed consent forms, completed training on the study protocol and software, and agreed to participate in a reader study. It's focused on improving diagnosis of Retinopathy of Prematurity (ROP) using an AI system.Check my eligibility
What is being tested?
The i-ROP DL system is being tested for its ability to accurately diagnose 'plus disease' in ROP through image analysis. The study will assess how image quality and camera operator influence results, aiming to validate the system as an autonomous AI screening device.See study design
What are the potential side effects?
Since this trial involves non-invasive imaging with no direct patient interventions like drugs or surgery, there are no typical side effects associated with it. However, inaccuracies in diagnosis could potentially affect clinical decision-making.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sensitivity and Specificity of I-ROP DL for mtmROP
Secondary outcome measures
Sensitivity and specificity of the I-ROP DL system for TR-ROP

Trial Design

1Treatment groups
Experimental Treatment
Group I: Reader StudyExperimental Treatment1 Intervention
Vascular Severity Score Provided on second reading

Find a Location

Who is running the clinical trial?

Siloam VisionLead Sponsor
National Eye Institute (NEI)NIH
547 Previous Clinical Trials
1,402,025 Total Patients Enrolled
15 Trials studying Retinopathy of Prematurity
4,642 Patients Enrolled for Retinopathy of Prematurity
John P Campbell, MD/MPHPrincipal InvestigatorOregon Health and Science University
~0 spots leftby Jul 2024
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