Retinal Disease
Conditions
Brief summary
The study evaluates image quality between two devices.
Interventions
DEVICEP200TxE
The P200TxE ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.
DEVICEP200DTx
The P200DTx ophthalmoscope provides widefield scanning laser ophthalmascope (SLO) fundus imaging.
Sponsors
Optos, PLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
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 diagnosed with retinal pathology. Example of pathologies may include but are not limited to Age-related Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Central Serous Retinopathy, and others as confirmed by the investigator;
Exclusion criteria
1. Subjects unable to tolerate ophthalmic imaging; 2. Subjects with ocular media not sufficiently clear to obtain acceptable images;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Image assessment | 6 months | Results from a qualitative assessment of the clinical utility and image quality of the images from both devices will be assessed from a clinician questionnaire and three independent masked and qualified graders using a four point scale (0-3). |
| Safety Assessment from Adverse Events | 6 months | 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