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| Name | Class |
|---|---|
| Elman Retina Group | OTHER |
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Primary objective:
To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in AMD (Age-related Macular Degeneration) patients.
Secondary objectives:
To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.
To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DME patients. OCT images from the central 10 degrees of the macula in DME patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images.
Patients will complete a questionnaire regarding the usability of the NOTAL-OCT v.2.5 device
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOTAL OCT v.2.5 and Commercial OCT on AMD Patients | OCT Images will be obtained in the central 10 degrees of the macula in AMD patients using the NOTAL OCT v.2.5 device and a Commercial device (Zeiss Cirrus/Heidelberg SPECTRALIS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5) | Device | OCT SCAN |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in AMD (Age-related Macular Degeneration) patients | To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of AMD patients. OCT images from the central 10 degrees of the macula in AMD patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images. | less than an hour |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of presence/absence of fluid on OCT images from NOTAL-OCT v.2.5 device with a commercial OCT device, in DR (Diabetic Retinopathy) patients | To evaluate the sensitivity and specificity regarding the presence and absence of fluid on OCT images of DR patients. OCT images from the central 10 degrees of the macula in DR patients will be obtained using the NOTAL OCT v.2.5 and a commercial OCT device (Zeiss Cirrus / Heidlberg SPECTRALIS). These images will be evaluated for the presence/absence of fluid in the images by a human grader. The sensitivity and specificity will be determined by comparison of the presence/absence of fluid in the NOTAL OCT v2.5 images with the presence/absence of fluid in the commercial OCT images. |
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Inclusion Criteria:
Exclusion Criteria:
- Any ophthalmic or systemic condition that in the opinion of the investigator would preclude the patient from participating in the study.
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AMD and DME patients
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| Name | Affiliation | Role |
|---|---|---|
| Michael Elman | Michael Elman, M.D. 9114 Philadelphia Rd #310 Baltimore, Maryland 21237 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elman Retina Group, PA | Baltimore | Maryland | 21237 | United States |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| less then an hour |
| Patient experience using the NOTAL-OCT v.2.5 device | Patients will complete a questionnaire with 13 statements or questions regarding the usability of the NOTAL-OCT v.2.5 device. For the first 10 statements, patients are asked to specify a level of agreement to the statement. The scale is named "Level of Agreement" and ranges from 1 = strongly agree, to 5 = strongly disagree. A patient's indicating a value of 1 is considered to be a better outcome. The remaining 3 questions are free-form. | less than an hour |