This study is a prospective comparative, randomized, single center study to assess agreement and precision of the Optos 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
137
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.
New England Retina Consultants
Springfield, Massachusetts, United States
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of full retinal thickness (μm).
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm).
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of ganglion cell complex thickness (μm).
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Limit of Agreement (LOA) between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio).
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of full retinal thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of retinal nerve fiber layer thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of ganglion cell complex thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision between the Optos P200TE and predicate device measurements of optic disc (area, volume, cup-to-disc ratio).
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Precision of the P200TE for the super pixel grid measurements of the full retinal thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision of the P200TE for the super pixel grid measurements of the RNFL thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)
Precision of the P200TE for the super pixel grid measurements of GCC thickness.
Time frame: At the end of Visit 1 or optional Visit 2 (each visit is 1 day)