An interventional study of Self-administered OCT imaging system and Technician-acquired OCT imaging in Obtaining OCT (Optical Coherence Tomography) Images, sponsored by Case Western Reserve University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Health services research
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.
Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use an OCT device to obtain OCT images of the eyes.
Procedure: Self-administered OCT imaging system
Technicians will use a standard OCT device to obtain OCT images of the eyes as per standard of care.
Procedure: Technician-acquired OCT imaging
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Case Western Reserve University →