Status:
ACTIVE_NOT_RECRUITING
Validation of i-ROP DL to Detect More Than Mild ROP
Lead Sponsor:
Siloam Vision
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Retinopathy of Prematurity
ROP
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief 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' perf...
Detailed Description
This clinical research is a retrospective, pivotal, multi-reader, multi-case (MRMC) study with an enriched sample of approximately 300 cases which will be selected from the library of telemedicine cas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06109285
Start Date
June 25 2024
End Date
March 1 2026
Last Update
December 17 2025
Active Locations (1)
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1
Oregon Health and Sciences University
Portland, Oregon, United States, 97239