Retinal Disease
Conditions
Brief summary
The primary objective is to collect images on the P200TxE device in diseased eyes.
Interventions
DEVICEP200TxE
SLO and OCT 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 subject 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; 4. Subjects who have been diagnosed with retinal pathology and/or glaucoma that affects the posterior pole region including the macula and/or optic nerve. For glaucoma subjects: a. Glaucoma subjects who have a history of visual field loss and RNFL or optic nerve changes.
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 |
|---|---|
| Number of images | 1 year |
Countries
United States
Outcome results
None listed