Trials / Active Not Recruiting
Active Not RecruitingNCT05808699
Camera Qualification Study
Camera Qualification of an Additional Fundus Camera Paired With An Autonomous AI for Detecting Diabetic Retinopathy
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 626 (actual)
- Sponsor
- Digital Diagnostics, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
A multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with IDx-DR.
Detailed description
A multi-center Study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | handheld fundus camera | Fundus camera |
Timeline
- Start date
- 2023-03-03
- Primary completion
- 2023-11-30
- Completion
- 2025-01-30
- First posted
- 2023-04-11
- Last updated
- 2024-10-22
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05808699. Inclusion in this directory is not an endorsement.