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To Compare the agreement and precision between the Topcon DRI OCT Triton and the 3D OCT-1 Maestro with RDB.
The objectives of this study are to compare the agreement and precision between Topcon DRI OCT Triton and 3D OCT-1 Maestro with RDB by measuring the thickness layers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects Presenting With Normal Eyes | Subjects with no known ocular diseases will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro |
| |
| Subjects presenting with Retinal Disease | Subjects with Retinal diseases will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro |
| |
| Subjects presenting with Glaucoma | Subjects with Glaucoma will be scanned on the Topcon DRI OCT Triton (plus) device and 3D OCT-1 Maestro |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topcon DRI OCT Triton (plus) | Device | The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Thickness | The thickness of the macula layer | 1 Minute |
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Inclusion Criteria for Normal Group
Exclusion Criteria for Normal Group
Subjects unable to tolerate ophthalmic imaging
Subjects 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 based on at least one of the following two findings:
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 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 presenting with Glaucoma, Retinal Diseases, or with no Ocular Pathology.
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| Name | Affiliation | Role |
|---|---|---|
| Charles Riesman, MS | Topcon Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fischer Laser Eye Center | Willmar | Minnesota | 56201 | United States |
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| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
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| 3D OCT-1 Maestro | Device | The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes |
|