Trials / Unknown
UnknownNCT06173232
Assessment of Retinal Fundus Imaging Camera
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Digital Diagnostics, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this prospective study is to evaluate device performance when using fundus images taken from retinal fundus cameras in subjects with and without diabetic retinopathy per ETDRS level 35 and higher with or without macular edema.
Detailed description
The goal of this prospective study is to evaluate device performance when using fundus images taken from retinal fundus cameras in subjects with and without diabetic retinopathy (ETDRS level 35 and higher) with or without macular edema. Study subjects will sign the informed consent form, and data collection will involve being imaged by cameras.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Camera Imaging | Camera Imaging |
Timeline
- Start date
- 2023-11-20
- Primary completion
- 2024-03-01
- Completion
- 2024-05-01
- First posted
- 2023-12-15
- Last updated
- 2023-12-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06173232. Inclusion in this directory is not an endorsement.