Obtaining OCT (Optical Coherence Tomography) ImagesNCT07584798
Self-Monitoring OCT
A study testing Self-administered OCT imaging system and Technician-acquired OCT imaging in people with Obtaining OCT (Optical Coherence Tomography) Images, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obtaining OCT (Optical Coherence Tomography) Images
- What is being tested?
- Self-administered OCT imaging system and Technician-acquired OCT imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 15 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Warren Sobol, MD
About this study
Official title: Self-Monitoring Optical Coherence Tomography Device for Retinal Telehealth
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.
- Being tested
- Self-administered OCT imaging system, Technician-acquired OCT imaging
- Keywords
- Ocular diseases, Eye care provider, Self monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered OCT imaging systemProcedure or surgery
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 imagingProcedure or surgery
Technician-acquired OCT obtained using routine clinical equipment during the same visit
| Study group | Role | What they receive |
|---|---|---|
| Self-administered OCT Images | Experimental | Participants will use an OCT device to obtain OCT images of the eyes. Receives: Procedure: Self-administered OCT imaging system |
| Technician-acquired OCT | Active comparator | Technicians will use a standard OCT device to obtain OCT images of the eyes as per standard of care. Receives: Procedure: Technician-acquired OCT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of inner retinal abnormalities detected as measured by OCT images
Measured: through study completion, an average of 1 year
Number of outer retinal abnormalities detected as measured by OCT images.
Measured: through study completion, an average of 1 year
Sensitivity as measured by OCT images.
Measured: through study completion, an average of 1 year
Specificity as measured by OCT images.
Measured: through study completion, an average of 1 year
Positive predictive value (PPV) as measured by OCT images.
Measured: through study completion, an average of 1 year
Negative predictive value (NPV) as measured by OCT images.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Image-quality as recorded by nurse coordinator during patient interaction with the device.
Measured: 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.
Measured: through study completion, an average of 1 year
Number of repeated attempts
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study startSep 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obtaining OCT (Optical Coherence Tomography) ImagesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warren Sobol, Case Western Reserve University
- Investigators
- Warren Sobol, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584798
- Sponsor's protocol ID
- STUDY20211004
- Status last verified
- Sep 2026
- First submitted
- 7 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No