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

Launched by SILOAM VISION · Oct 30, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Validation of i-ROP DL to Detect More Than Mild ROP," is studying how effectively eye doctors can diagnose a specific eye condition called retinopathy of prematurity (ROP) using a new tool called i-ROP DL. ROP is a serious eye disease that can affect premature babies, and it’s important to detect it early to prevent vision problems. The trial will compare how well doctors can identify "plus disease," a more severe form of ROP, both with and without the help of this new tool. About 300 eye cases will be reviewed by trained eye doctors participating in the study.

To be eligible to participate, doctors must be licensed and board-certified in ophthalmology in the U.S. They also need to agree to the study terms and successfully complete training on how to use the study materials. This study is currently recruiting participants, and it aims to provide more accurate ways for doctors to diagnose ROP, which could ultimately improve care for at-risk infants. If you know a doctor who meets these criteria and is interested in contributing to this important research, they may want to get involved!

Gender

ALL

Eligibility 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