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COVD-19
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Evaluate the ability and accuracy of the Retinal Health Monitoring System - Retinal Thickness Module (RHMS - RTM).
Evaluation of the Retinal Health Monitoring System - Retinal Thickness Module in subjects with normal macular thickness and subjects with center-involving macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Subjects with normal macular thickness in one or both eyes. |
| |
| Group 2 | Subjects with center-involving macular edema due to w/AMD in one or both eyes. |
| |
| Group 3 | Subjects with center-involving macular edema due to DR or RVO in one or both eyes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RHMS-RTM | Device | Assessment of retinal thickness. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the RHMS-RTM retinal thickness measurements | To evaluate the ability of the RHMS-RTM device to measure retinal thickness | 1 day |
| RHMS-RTM repeatability | To assess repeatability of the RHMS-RTM device | 1 day |
| Comparison of retinal thickness measurements between the RHMS-RTM and the SD-OCT | To evaluate the agreement of measurements by the RHMS-RTM and SD-OCT | 1 month |
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Inclusion Criteria:
Corrected visual acuity (VA) of 20/100 or better, in the study eye(s)
Media clarity, undilated pupil size, OCT-B scans, axial length measurements in the study eye(s)
Able to perform self-testing of retinal thickness with the RHMS-RTM after training
Able and willing to give informed consent
Group 1:
Group 2 and Group 3 (in at least one or the same eye):
Exclusion Criteria:
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Subjects aged ≥ 18 years old with normal macular thickness, center-involving macular edema due to wAMD, diabetic retinopathy or retinal vein occlusion.
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Gregory, MD | Kubota Vision Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants Medical Group, Inc | Sacramento | California | 95819 | United States |
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D008268 | Macular Degeneration |
| D003930 | Diabetic Retinopathy |
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
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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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| SD-OCT | Diagnostic Test | Assessment of retinal structure. |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |