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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optical Coherence Tomography (OCT) | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P200TE | Device | The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device. |
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| Measure | Description | Time Frame |
|---|---|---|
| Limit of Agreement (LOA) between the P200TE and predicate device measurements of full retinal thickness. | 1 year | |
| Limit of Agreement (LOA) between the P200TE and predicate device measurements of retinal nerve fiber layer thickness (μm). | 1 year | |
| Limit of Agreement (LOA) between the P200TE and predicate device measurements of ganglion cell complex thickness (μm). | 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) | 1 year | |
| Precision between the P200TE and predicate device measurements of full retinal thickness. | 1 year | |
| Precision between the P200TE and predicate device measurements of retinal nerve fiber layer thickness. | 1 year | |
| Precision between the P200TE and predicate device measurements of ganglion cell complex thickness | 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) | 1 year |
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Inclusion Criteria for Normal Group
Exclusion Criteria for Normal Group
Inclusion Criteria for Glaucoma Group
Subjects 22 years of age or older on the date of informed consent
Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
BCVA 20/40 or better in the study eye
History of Visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings:
Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
Exclusion Criteria for Glaucoma Group
Inclusion Criteria for Retina Disease Group
Exclusion Criteria for Retinal Disease Group
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illinois College of Optometry | Chicago | Illinois | 60616 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Predicate Device | 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. |
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