The P200TxE will be used to obtain peripheral OCT (optical coherence tomography) images.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
26
The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
Retina Consultants of San Diego
Poway, California, United States
Qualitative Assessment of OCT Clinical Utility
Clinical utility of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
Time frame: 1 year
Qualitative Assessment of OCT Scan Quality
Image quality of the OCT scans will be assessed from the clinician questionnaire using a four point scale.
Time frame: 1 year
Safety Assessment from Adverse Events
Analysis of safety will be assessed through adverse events reported by the site and documented on each subject's case report form.
Time frame: 1 year
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