Self-Monitoring OCT

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obtaining OCT (Optical Coherence Tomography) Images
• Intervention / Treatment: Procedure: Self-administered OCT imaging system; Procedure: Technician-acquired OCT imaging

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
      • Principal Investigator: Warren Sobol, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-administered OCT Images; Participants will use an OCT device to obtain OCT images of the eyes.	Procedure: Self-administered OCT imaging system; 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.
Active Comparator: Technician-acquired OCT; Technicians will use a standard OCT device to obtain OCT images of the eyes as per standard of care.	Procedure: Technician-acquired OCT imaging; Technician-acquired OCT obtained using routine clinical equipment during the same visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of inner retinal abnormalities detected as measured by OCT images	through study completion, an average of 1 year
Number of outer retinal abnormalities detected as measured by OCT images.	through study completion, an average of 1 year
Sensitivity as measured by OCT images.	through study completion, an average of 1 year
Specificity as measured by OCT images.	through study completion, an average of 1 year
Positive predictive value (PPV) as measured by OCT images.	through study completion, an average of 1 year
Negative predictive value (NPV) as measured by OCT images.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Image-quality as recorded by nurse coordinator during patient interaction with the device.	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.	through study completion, an average of 1 year
Number of repeated attempts	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Investigators: Principal Investigator: Warren Sobol, MD, University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 15, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Self monitoring; Ocular diseases; Eye care provider
• Other Study ID Numbers: STUDY20211004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No