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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
125
The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
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.
Illinois College of Optometry
Chicago, Illinois, United States
RECRUITINGLimit of Agreement (LOA) between the P200TE and predicate device measurements of full retinal thickness.
Time frame: 1 year
Limit of Agreement (LOA) between the P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).
Time frame: 1 year
Limit of Agreement (LOA) between the P200TE and predicate device measurements of ganglion cell complex thickness (μm).
Time frame: 1 year
Limit of Agreement (LOA) between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)
Time frame: 1 year
Precision between the P200TE and predicate device measurements of full retinal thickness
Time frame: 1 year
Precision between the P200TE and predicate device measurements of retinal nerve fiber layer thickness.
Time frame: 1 year
Precision between the P200TE and predicate device measurements of ganglion cell complex thickness
Time frame: 1 year
Precision between the P200TE and predicate device measurements of optic disc (disc area, rim area, cup-to-disc area, cup-to-disc vertical, cup-to-disc horizontal)
Time frame: 1 year
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