Self-Monitoring OCT

Conditions

• Obtaining OCT (Optical Coherence Tomography) Images

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.
• Technician-acquired OCT imaging — PROCEDURE
  Technician-acquired OCT obtained using routine clinical equipment during the same visit

Study Details

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.

Key Dates

Start date

Jul 1, 2026

Status verified

May 2026

Primary completion

Dec 15, 2027

Completion

Dec 15, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Self-administered OCT Images
  Participants will use an OCT device to obtain OCT images of the eyes.
• Active Comparator: Technician-acquired OCT
  Technicians will use a standard OCT device to obtain OCT images of the eyes as per standard of care.

Primary Outcome Measure

Number of inner retinal abnormalities detected as measured by OCT images [ Time Frame: Up to 60 minutes ]

Locations (1)

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