Self-Monitoring OCT (NCT07584798) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Self-Monitoring OCT
United States100 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<20/200.
* 7\. Patients with significant media opacities precluding an OCT scan (posterior subcapsular cataract, vitreous hemorrhage, etc), or severe ptosis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of inner retinal abnormalities detected as measured by OCT images
Timeframe: Up to 60 minutes
2
Number of outer retinal abnormalities detected as measured by OCT images.
Timeframe: Up to 60 minutes
3
Sensitivity as measured by OCT images.
Timeframe: Up to 60 mins
4
Specificity as measured by OCT images.
Timeframe: Up to 60 mins
5
Positive predictive value (PPV) as measured by OCT images.
Timeframe: Up to 60 mins
6
Negative predictive value (NPV) as measured by OCT images.