Self-Monitoring OCT for Retinal Imaging

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Western Reserve University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

WS

Warren Sobol, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) who are visiting a University Hospitals Eye Institute clinic, are scheduled for standard eye imaging (OCT), and are willing to fill out study questionnaires.

Inclusion Criteria

I have signed and dated the informed consent form.
I am receiving care at a University Hospitals Eye Institute clinic.
I am willing to fill out study questionnaires.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Self-monitoring

Participants use an OCT device to obtain OCT images of the eyes without the help of an eye technician

8 weeks
Participants self-monitor at home

Technician-acquired OCT

Technicians use a standard OCT device to obtain OCT images of the eyes as per standard of care

8 weeks
Regular visits to eye care provider

Follow-up

Participants are monitored for safety and effectiveness after the self-monitoring phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Self-administered OCT imaging system
  • Technician-acquired OCT imaging

Trial Overview

The study compares two ways of getting detailed images of the eyes: one where patients use an OCT device themselves, and another where a trained technician takes the images. The goal is to see if self-imaging works as well as technician-acquired imaging.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Self-administered OCT ImagesExperimental Treatment1 Intervention
Group II: Technician-acquired OCTActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials
314
Recruited
236,000+