Self-Monitoring OCT

NCT07584798 | Not Yet Recruiting DMC

• 1 other identifier: STUDY20211004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obtaining OCT (Optical Coherence Tomography) Images

Keywords

Ocular diseases; Eye care provider; Self monitoring

Outcome Measures

Primary Outcomes (6)

• Number of inner retinal abnormalities detected as measured by OCT images

  Up to 60 minutes

• Number of outer retinal abnormalities detected as measured by OCT images.

  Up to 60 minutes

• Sensitivity as measured by OCT images.

  Up to 60 mins

• Specificity as measured by OCT images.

  Up to 60 mins

• Positive predictive value (PPV) as measured by OCT images.

  Up to 60 mins

• Negative predictive value (NPV) as measured by OCT images.

  Up to 60 mins

Secondary Outcomes (3)

• Image-quality as recorded by nurse coordinator during patient interaction with the device.

  Up to 60 mins

• Number of successful completion of self-scans as recorded by nurse coordinator during patient interaction with the device.

  Up to 60 mins

• Number of repeated attempts

  Up to 60 mins

Study Arms (2)

Self-administered OCT Images

EXPERIMENTAL

Participants will use an OCT device to obtain OCT images of the eyes.

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.

Procedure: Technician-acquired OCT imaging

Interventions

Self-administered OCT imaging system PROCEDURE

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.

Self-administered OCT Images

Technician-acquired OCT imaging PROCEDURE

Technician-acquired OCT obtained using routine clinical equipment during the same visit

Technician-acquired OCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Provision of signed and dated informed consent.
• \. Age ≥ 18 years.
• \. Presenting for care at a University Hospitals Eye Institute clinic
• \. Willing to complete study questionnaires.
• \. Scheduled to undergo standard technician-acquired OCT

You may not qualify if:

• \. Unable to provide informed consent or, in the judgment of study staff, unable to understand study procedures.
• \. 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).
• \. Facial skin condition or open wound at the points of device contact that would make use of the headrest unsafe.
• \. Acute medical or ocular condition requiring immediate evaluation that, in the PI's judgment, precludes participation at that time.
• \. Any other condition that, in the opinion of the PI/designee, would place the participant at undue risk or compromise data quality (documented).
• \. Patients with visual acuity \<20/200.
• \. Patients with significant media opacities precluding an OCT scan (posterior subcapsular cataract, vitreous hemorrhage, etc), or severe ptosis.

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Study Officials

• Warren Sobol, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)