Obtaining OCT (Optical Coherence Tomography) Images
Conditions
Keywords
Ocular diseases, Eye care provider, Self monitoring
Brief summary
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.
Interventions
PROCEDURESelf-administered OCT imaging system
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.
PROCEDURETechnician-acquired OCT imaging
Technician-acquired OCT obtained using routine clinical equipment during the same visit
Sponsors
Case Western Reserve University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 1\. Provision of signed and dated informed consent. * 2\. Age ≥ 18 years. * 3\. Presenting for care at a University Hospitals Eye Institute clinic * 4\. Willing to complete study questionnaires. * 5\. Scheduled to undergo standard technician-acquired OCT
Exclusion criteria
* 1\. Unable to provide informed consent or, in the judgment of study staff, unable to understand study procedures. * 2\. Unable to cooperate with imaging or maintain stable positioning such that an evaluable OCT scan cannot be obtained (e.g., severe tremor or inability to maintain head position). * 3\. Facial skin condition or open wound at the points of device contact that would make use of the headrest unsafe. * 4\. Acute medical or ocular condition requiring immediate evaluation that, in the PI's judgment, precludes participation at that time. * 5\. Any other condition that, in the opinion of the PI/designee, would place the participant at undue risk or compromise data quality (documented). * 6\. Patients with visual acuity \<20/200. * 7\. Patients with significant media opacities precluding an OCT scan (posterior subcapsular cataract, vitreous hemorrhage, etc), or severe ptosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of inner retinal abnormalities detected as measured by OCT images | through study completion, an average of 1 year |
| Number of outer retinal abnormalities detected as measured by OCT images. | through study completion, an average of 1 year |
| Sensitivity as measured by OCT images. | through study completion, an average of 1 year |
| Specificity as measured by OCT images. | through study completion, an average of 1 year |
| Positive predictive value (PPV) as measured by OCT images. | through study completion, an average of 1 year |
| Negative predictive value (NPV) as measured by OCT images. | through study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Image-quality as recorded by nurse coordinator during patient interaction with the device. | 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. | through study completion, an average of 1 year |
| Number of repeated attempts | through study completion, an average of 1 year |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORWarren Sobol, MD
University Hospitals Cleveland Medical Center
Outcome results
None listed