Self-Monitoring Optical Coherence Tomography Device for Retinal Telehealth
Sponsor: Case Western Reserve University
Trial Details
| Condition | Obtaining OCT (Optical Coherence Tomography) Images |
| Intervention | Self-administered OCT imaging system; Technician-acquired OCT imaging |
| Phase | NA |
| Status | Not_yet_recruiting |
| Participants | 100 |
| Est. Completion | 15 Dec 2027 |
| Last Updated | 13 May 2026 |
Primary Outcome
Number of inner retinal abnormalities detected as measured by OCT images; Number of outer retinal abnormalities detected as measured by OCT images.; Sensitivity as measured by OCT images.; Specificity as measured by OCT images.; Positive predictive value (PPV) as measured by OCT images.; Negative predictive value (NPV) as measured by OCT images.
Eligibility Criteria
Inclusion Criteria
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.
Trial Sites
Countries
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