Self-Monitoring Optical Coherence Tomography Device for Retinal Telehealth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Positive predictive value (PPV) as measured by OCT images.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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/
- •7. Patients with significant media opacities precluding an OCT scan (posterior subcapsular cataract, vitreous hemorrhage, etc), or severe ptosis.
Arms & Interventions
Technician-acquired OCT
Technicians will use a standard OCT device to obtain OCT images of the eyes as per standard of care.
Intervention: Technician-acquired OCT imaging (Procedure)
Self-administered OCT Images
Participants will use an OCT device to obtain OCT images of the eyes.
Intervention: Self-administered OCT imaging system (Procedure)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- 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)
Investigators
Warren Sobol
Physician
Case Western Reserve University