Trials / Unknown
UnknownNCT05624593
P200TE and Predicate Agreement and Precision Study
P200TE Agreement and Precision Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 125 (estimated)
- Sponsor
- Optos, PLC · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
This study is a prospective comparative, randomized, single center study to assess agreement and precision of the P200TE in comparison to the predicate device in normal subjects, subjects with glaucoma, and subjects with retinal disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | P200TE | The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device. |
| DEVICE | Predicate | The predicate device is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures. |
Timeline
- Start date
- 2022-11-04
- Primary completion
- 2023-03-01
- Completion
- 2023-03-01
- First posted
- 2022-11-22
- Last updated
- 2022-11-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05624593. Inclusion in this directory is not an endorsement.