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Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, Full Retinal Thickness, and Ganglion Cell Thickness between the Maestro and iVue OCT devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Eyes | Subjects with no known ocular diseases will be scanned with the iVue and Maestro device |
| |
| Glaucomatous Eyes | Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device |
| |
| Eyes with Retinal Diseases | Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D OCT-1 Maestro | Device | OCT machines used for diagnostic purposes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Optic Disc Measurements (Optic Disc/Cup Size) | Reporting of the Optic Disc Size and Cup Size | 1 Hour |
| Retinal Nerve Fiber Layer (RNFL) Thickness Measurements At Different Clock Hours | RNFL thickness measured at different clock hours | 1 Hour |
| Full Retinal Thickness Measurements | Full Retinal Thicknesses measured in different quadrants of the scan | 1 Hour |
| Ganglion Cell Thickness Measurements | Ganglion Cell Thickness measured in different quadrants of the scan | 1 Hour |
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Inclusion Criteria for Normal Group
Exclusion Criteria for Normal Group
Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
Subjects unable to tolerate ophthalmic imaging
Subject with ocular media not sufficiently clear to obtain acceptable OCT images
HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses> 20% or false positives> 33%, or false negatives> 33%
Visual field defects consistent with glaucomatous optic nerve damage with at least one of the following two findings:
Presence of any ocular pathology except for cataract
Narrow angle
History of leukemia, dementia or multiple sclerosis
Concomitant use of hydroxychloroquine and chloroquine
Inclusion Criteria for Glaucoma Group
Subjects 18 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
Visual field defects consistent with glaucomatous optic nerve damage based on 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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Subjects with no eye disease and subjects with retinal disease or glaucoma.
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| Name | Affiliation | Role |
|---|---|---|
| Charles Reisman, MS | Topcon Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western University of Health Sciences | Pomona | California | 91716 | United States |
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| iVue | Device | OCT machines used for diagnostic purposes |
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