NCT05471986

Multicenter Diagnostic Clinical Performance Study For Automated Detection of Diabetic Retinopathy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 900 (estimated)
• Sponsor: Ural Telekomunikasyon Sanayi Ticaret Anonim Sirketi · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

This study is a retrospective study to assess the efficacy and accuracy of the EyeCheckup software in screening for diabetic retinopathy in healthcare settings.

Detailed description

This is a clinical diagnostic performance study for EyeCheckup with data obtained consecutively at multiple geographically different sites within the US population. These sites include all healthcare settings with a trained ophthalmic camera operator using non-mydriatic cameras that are compatible with EyeCheckup. Moreover, primary endpoints are devised that will be used to validate EyeCheckup to diagnose DR in the primary care and eye care settings. During this color fundus images representing either 4 wide field or 7 standard fields of view will be graded by a qualified professional for diabetic retinopathy according to ETDRS on DRSS scale. The human grading output will be compared with diagnosis generated for diabetic retinopathy by AI software. A comparison of both these grades will be used to determine sensitivity and specificity for the EyeCheckup software for screening for diabetic retinopathy.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DEVICE	Color Fundus Photography/Non-Mydriatic Opthalmic Cameras	Subjects will have underwent Fundus Photography using FDA approved non-mydriatic fundus cameras compatible with EyeCheckup which are either TOPCON NW400, CANNON CR2, CANNON CR2 Plus or OPTOMED AURORA IQ

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-07-25
• Last updated: 2023-11-29

Regulatory

• FDA-regulated device study