Not_yet_recruitingNANCT07584798

Self-Monitoring Optical Coherence Tomography Device for Retinal Telehealth

Sponsor: Case Western Reserve University

Trial Details

ConditionObtaining OCT (Optical Coherence Tomography) Images
InterventionSelf-administered OCT imaging system; Technician-acquired OCT imaging
PhaseNA
StatusNot_yet_recruiting
Participants100
Est. Completion15 Dec 2027
Last Updated13 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

United States
View Registry Entry

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