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NCT Number: NCT07584798

Self-Monitoring OCT

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.

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Key information

Conditions

Obtaining OCT (Optical Coherence Tomography) Images

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location contact

Warren Sobol, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Technician-acquired OCT imaging

Procedure

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

Primary outcomes

  1. Number of inner retinal abnormalities detected as measured by OCT images

    Time frame: Up to 60 minutes

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

    Time frame: Up to 60 minutes

  3. Sensitivity as measured by OCT images.

    Time frame: Up to 60 mins

  4. Specificity as measured by OCT images.

    Time frame: Up to 60 mins

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

    Time frame: Up to 60 mins

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

    Time frame: Up to 60 mins

Secondary outcomes

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

    Time frame: Up to 60 mins

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

    Time frame: Up to 60 mins

  3. Number of repeated attempts

    Time frame: Up to 60 mins

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

Self-Monitoring Optical Coherence Tomography Device for Retinal Telehealth

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.