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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Monitoring Optical Coherence Tomography Device for Retinal Telehealth
- ClinicalTrials.gov ID
- NCT07584798
- Acronym / sponsor ID
- STUDY20211004
- Keywords
- Ocular diseases, Eye care provider, Self monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-administered OCT Images | Experimental | Procedure: Self-administered OCT imaging systemParticipants will use an OCT device to obtain OCT images of the eyes. |
| Technician-acquired OCT | Active comparator | Procedure: Technician-acquired OCT imagingTechnicians will use a standard OCT device to obtain OCT images of the eyes as per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered OCT imaging systemSelf-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. | Procedure or surgery | Self-administered OCT Images |
| Technician-acquired OCT imagingTechnician-acquired OCT obtained using routine clinical equipment during the same visit | Procedure or surgery | Technician-acquired OCT |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Warren Sobol, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of inner retinal abnormalities detected as measured by OCT images (time frame: through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.