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This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess two grids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | Eyes judged as age-appropriate normal as determined by an Investigator and that meet applicable inclusion/exclusion criteria. |
| |
| Glaucoma | Eyes that have been diagnoses with Glaucoma |
| |
| Retinal Disease | Eyes that have been diagnoses with a Retinal Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography | Device | Imaging of the Retina |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Layer Thickness | Measurement of the thickness of Retinal layers thickness to assess 2 grids | 5 months |
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Inclusion All Eye Populations
Exclusion All Eye Populations
Inclusion Normal Population
Exclusion Normal Population
Fixation losses > 20%, False Positives > 33%, False Negatives > 15%
-Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings: On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; Glaucoma hemi-field test "outside normal limits"
Inclusion Glaucoma Population
Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue
Exclusion Glaucoma Population
Fixation losses > 20%, False Positives > 33%, False Negatives > 15%
Inclusion Retina Population
Exclusion Retina Population
-Subjects with presence of any ocular pathology other than retinal conditions in the study eye (cataracts are acceptable)
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Normals, Glaucoma and Retinal Subjects as per Inclusion/Exclusion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State University of New York Optometry School | New York | New York | 10036 | United States |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |