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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)NIH

547 Previous Clinical Trials

1,402,141 Total Patients Enrolled

15 Trials studying Retinopathy of Prematurity

4,642 Patients Enrolled for Retinopathy of Prematurity

Siloam VisionLead Sponsor

John P Campbell, MD/MPHPrincipal InvestigatorOregon Health and Science University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial available to those who have reached the age of majority?

"Prospective participants must be between 20 and 80 years old to qualify for enrollment in the clinical trial."

Answered by AI

What is the total number of individuals involved in this research investigation?

"Affirmative. The data available on clinicaltrials.gov confirms that this medical investigation is currently seeking eligible individuals to enroll. This study was first listed on November 29, 2023, and last revised on April 15, 2024. A total of 16 participants are sought from a single research site."

Answered by AI

Is it possible for me to be included as a participant in this clinical trial?

"Recruitment is underway for 16 candidates aged between 20 and 80 diagnosed with retinopathy of prematurity. In addition, individuals must fulfill the subsequent requirements: Provision of signed informed consent, Completion of successful training on study protocol and utilization of research software tools, Submission of a signed reader study agreement, Possession of U.S. board-eligible/board-certified status as a Medical Doctor or Ophthalmologist (certification from the American Board of Ophthalmology or its equivalent)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Validation of i-ROP DL to Detect More Than Mild ROP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06109285.

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