Self-Monitoring OCT
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Western Reserve University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Self-administered OCT imaging system
Procedure/SurgerySelf-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 imaging
Procedure/SurgeryTechnician-acquired OCT obtained using routine clinical equipment during the same visit
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Self-administered OCT ImagesExperimental treatment 1 intervention
Group B: Technician-acquired OCTActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of inner retinal abnormalities detected as measured by OCT images
Time frame
through study completion, an average of 1 year2
Number of outer retinal abnormalities detected as measured by OCT images.
Time frame
through study completion, an average of 1 year3
Sensitivity as measured by OCT images.
Time frame
through study completion, an average of 1 year4
Specificity as measured by OCT images.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Image-quality as recorded by nurse coordinator during patient interaction with the device.
Time frame
through study completion, an average of 1 year2
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 year3
Number of repeated attempts
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: