Retinal Disease
Conditions
Brief summary
The P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.
Interventions
DEVICEDevice: P200TxE
The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
Sponsors
Optos, PLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed; 2. Subjects who can follow the instructions by the clinical staff at the clinical site, 3. Subjects who agree to participate in the study; 4. Subjects presenting with some form of peripheral retina pathology or retina pathology with peripheral manifestations.
Exclusion criteria
1. Subjects unable to tolerate ophthalmic imaging; 2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Assessment of OCT Scan Quality | 1 year | Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale. |
| Qualitative Assessment of OCT Clinical Utility | 1 year | Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment from Adverse Events | 1 year | Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form. |
Countries
United States
Outcome results
None listed