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This study is a prospective comparative study to gather pilot agreement and precision data in normal subjects, subjects with glaucoma, and subjects with retinal disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Random Sequenced Interventions | Other | Participants from three condition groups (normal, glaucoma, retinal disease) assigned two interventions (Kowa OCT Bi-μ and the Optovue iVue 100) under random sequence assignments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KOWA OCT Bi-µ | Device | Non-contact, ultra-high resolution ophthalmic imaging system for fundus imaging and axial cross-sectional and three-dimensional imaging of retinal structures. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare KOWA OCT Bi-μ and Optovue iVue 100 |
| 1-2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Evaluate any adverse events found during the clinical study | Evaluate any adverse events found during the clinical study | 1-2 days |
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Inclusion Criteria (Normal Group):
Exclusion Criteria (Normal Group):
Inclusion Criteria (Glaucoma Group):
Subjects who have been diagnosed with glaucoma in the glaucoma study eye(s), with optic nerve damage as evidenced by either of the following optic disc or retinal nerve fiber layer structural abnormalities observed via fundus exam during the study visit:
Subjects with a current BSCVA of 20/40 or better in the glaucoma study eye(s) on the date of the visit; and
History of visual field defects within the previous two (2) months from the study visit or measured on the day of the study visit that is consistent with glaucomatous optic nerve damage based on at least one of the following findings:
Exclusion Criteria (Glaucoma Group):
Inclusion Criteria (Retinal Disease Group):
Exclusion Criteria (Retinal Disease Group):
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| Name | Affiliation | Role |
|---|---|---|
| David Hosford, MD, Ph.D | Kowa Research Institute, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Eligible participants assigned two interventions under random sequence assignments.
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| Optovue iVue 100 | Device | U.S. Food and Drug Administration (FDA) cleared and commercially available Optovue iVue 100 |
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