NCT05806957

Pivotal Trial to Assess the Clinical Performance of Ophthal-360 for the Detection of Diabetic Retinopathy

Pivotal Trial to Assess the Clinical Performance of Ophthal-360

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Ophthalytics, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

Multicenter, prospective, study to assess the performance of the Ophthal-360 platform in the diagnosis of more-than-mild Diabetic Retinopathy (mtmDR) in diabetic patients with no previous diagnosis of DR.

Detailed description

This is a multicenter, prospective study in which 500 adult subjects at risk for DR but never before diagnosed who satisfy all entry criteria will be enrolled at up to 5 primary care sites. An additional sub-study will be performed on 30 subjects to assess the precision of the algorithm in detecting DR by imaging these subjects multiple times to demonstrate intra- and inter-operator reliability of the algorithm. All enrolled subjects will undergo retinal imaging by a novice operator with no experience using the fundus cameras listed. Images from each retinal imaging device will be saved to a computer and uploaded to the server for evaluation by the Ophthal-360 service. A report will be generated and archived for the results of each image. After imaging by the novice operator, each patient will then have their eyes photographed by a professional fundus photographer using standard mydriatic and OCT imaging for macular edema evaluation. These images will be sent to a Fundus Photography Reading Center for final determination and diagnosis. Patients will received the result of the FPRC evaluation, but not be provided the reports generated by the software. A comparison between the FPRC determination and the software generated report will be performed to evaluate the analytical performance of the algorithm.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DEVICE	Fundus Photography	Subjects will undergo Fundus Photography using FDA approved non-mydriatic fundus cameras and mydriatic camera with OCT

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-09-01
• Completion: 2024-09-30
• First posted: 2023-04-10
• Last updated: 2023-04-10

Regulatory

• FDA-regulated device study