Validation of a deep learning tool for detecting retinopathy of prematurity
Validation of i-ROP DL to Detect More Than Mild Retinopathy of Prematurity and a Multi-Reader Multi-Case Controlled Clinical Trial to Evaluate the Comparative Accuracy of Diagnosing Plus Disease of Premature Infants With or Without the Aid of the i-ROP DL in Telemedicine Setting
This study is testing if a new deep learning tool can help eye doctors better detect a serious eye condition in premature babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Siloam Vision Industry-sponsored |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06109285 on ClinicalTrials.gov |
What this trial studies
This clinical research evaluates the accuracy of ophthalmologists in diagnosing plus disease in retinopathy of prematurity (ROP) using a deep learning tool called i-ROP DL. The study involves a retrospective analysis of approximately 300 eye cases, comparing the performance of standard evaluations with and without the aid of i-ROP DL. The primary goal is to determine if the use of i-ROP DL improves diagnostic accuracy as measured by the area under the receiver operating characteristic curve (AUC). The study ensures confidentiality and utilizes deidentified data from a previous telemedicine study.
Who should consider this trial
Good fit: Ideal candidates for this study are board-certified ophthalmologists trained in the use of the study software and protocols.
Not a fit: Patients who are not board-certified ophthalmologists or who do not meet the training and consent requirements will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of ROP diagnosis, leading to better treatment outcomes for affected infants.
How similar studies have performed: Other studies have shown promise in using deep learning tools for medical diagnostics, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: 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 this trial is running
Portland, Oregon
- Oregon Health and Sciences University — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: John P Campbell, MD/MPH — Oregon Health and Science University
- Study coordinator: Karyn E Jonas, MSN
- Email: karyn@siloamvision.com
- Phone: 5618182161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.