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The purpose of this research study is to test participants ability to obtain OCT images of the eyes using an OCT device that is comparable to FDA-approved OCT devices on the market, without the help of an eye technician. Patients with ocular diseases often need to come to frequent appointments with an eye care provider for close monitoring and evaluation. Transportation difficulties, other medical problems, and limited appointments slots can make regular follow-up challenging. In addition, the anxiety of permanent vision loss and subjective nature of monitoring symptoms highlight the need for an alternative solution in which patients can self-generate OCT images of the eye for the eye care provider to review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-administered OCT Images | Experimental | Participants will use an OCT device to obtain OCT images of the eyes. |
|
| Technician-acquired OCT | Active Comparator | Technicians will use a standard OCT device to obtain OCT images of the eyes as per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-administered OCT imaging system | Procedure | Self-administered OCT imaging using modified portable OCT with headrest and software workflow to enable patient self-operation and secure image transfer to a remote reading center. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of inner retinal abnormalities detected as measured by OCT images | Up to 60 minutes | |
| Number of outer retinal abnormalities detected as measured by OCT images. | Up to 60 minutes | |
| Sensitivity as measured by OCT images. | Up to 60 mins | |
| Specificity as measured by OCT images. | Up to 60 mins | |
| Positive predictive value (PPV) as measured by OCT images. | Up to 60 mins | |
| Negative predictive value (NPV) as measured by OCT images. | Up to 60 mins |
| Measure | Description | Time Frame |
|---|---|---|
| Image-quality as recorded by nurse coordinator during patient interaction with the device. | Up to 60 mins | |
| Number of successful completion of self-scans as recorded by nurse coordinator during patient interaction with the device. | Up to 60 mins |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Warren Sobol, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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| Technician-acquired OCT imaging | Procedure | Technician-acquired OCT obtained using routine clinical equipment during the same visit |
|
| Number of repeated attempts | Up to 60 mins |