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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
100
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.
Technician-acquired OCT obtained using routine clinical equipment during the same visit
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Number of inner retinal abnormalities detected as measured by OCT images
Time frame: through study completion, an average of 1 year
Number of outer retinal abnormalities detected as measured by OCT images.
Time frame: through study completion, an average of 1 year
Sensitivity as measured by OCT images.
Time frame: through study completion, an average of 1 year
Specificity as measured by OCT images.
Time frame: through study completion, an average of 1 year
Positive predictive value (PPV) as measured by OCT images.
Time frame: through study completion, an average of 1 year
Negative predictive value (NPV) as measured by OCT images.
Time frame: through study completion, an average of 1 year
Image-quality as recorded by nurse coordinator during patient interaction with the device.
Time frame: through study completion, an average of 1 year
Number of successful completion of self-scans as recorded by nurse coordinator during patient interaction with the device.
Time frame: through study completion, an average of 1 year
Number of repeated attempts
Time frame: through study completion, an average of 1 year
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