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?

This trial tests a new method for individuals with eye conditions to capture images of their retinas (the light-sensitive part of the eye) at home using a self-administered OCT imaging system, similar to devices used by eye doctors. The goal is to reduce the need for frequent eye doctor visits, which can be challenging due to travel issues or health problems. Participants will either use this self-monitoring device or have images taken by a technician as usual. Suitable candidates have an eye condition requiring regular monitoring and are scheduled for standard OCT imaging at the eye clinic. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could make eye care more accessible and convenient.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing a device for eye imaging, so it's unlikely that your medications would be affected, but you should confirm with the study team.

What prior data suggests that this OCT device is safe for self-monitoring?

Studies have shown that the self-administered OCT imaging system is safe to use. In a recent study, 96% of participants successfully took pictures of their eyes at home without technician assistance. This indicates that the system is easy to use and does not seem to cause harm when used independently.

Another study found that participants successfully captured images 93.7% of the time. This high success rate suggests that the device is both effective and reliable. Additionally, the American Academy of Ophthalmology reports a low risk of personal data misuse from the images.

Overall, users tolerate the self-imaging OCT device well, with no major safety concerns reported in these studies.12345

Why are researchers excited about this trial?

Most treatments for retinal imaging require a visit to an eye clinic, where technicians use specialized equipment to capture images of the retina. But the self-administered OCT imaging system offers a new approach by allowing patients to capture these images themselves at home. This unique feature provides increased convenience and accessibility, potentially leading to better monitoring and management of eye health. Researchers are excited because this method could make regular retinal monitoring easier and more frequent, ultimately improving early detection and treatment outcomes for retinal conditions.

What evidence suggests that this self-administered OCT imaging system is effective for retinal imaging?

Research has shown that people can effectively use self-administered OCT (optical coherence tomography) to capture clear images of their eyes. In one study, participants successfully took their own eye images 93.7% of the time. Another study demonstrated that this method accurately identified certain eye conditions, with a sensitivity of 87.69% and a specificity of 98.29%. By following simple visual instructions, patients captured clear images independently. In this trial, participants will either use the self-administered OCT imaging system or have images taken by a technician using a standard OCT device. These findings suggest that self-administered OCT could reliably allow people to check their eye health at home.678910

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+

Citations

Pivotal Trial Toward Effectiveness of Self-administered ...

Self-imaging was performed successfully by 387 participants in 2451 of 2616 attempts (93.7%). For repeatability, the coefficient of variance for ...

Expanding Access to Retinal Imaging Through Patient ... - PMC

This study evaluated the feasibility, image quality, and referral accuracy of a patient-operated optical coherence tomography (OCT) device ...

Cost-effectiveness of incorporating self-imaging optical ...

We found that the FP + SI-OCT strategy demonstrated superior sensitivity (87.69% vs 61.53%) and specificity (98.29% vs 92.47%) in detecting DME when compared ...

Usability and Quality of Retinal Images Captured by a Self- ...

The images were successfully self-captured solely by patients moving their head and gaze in response to directional visual feedback; most clinic-based OCT ...

The Future of Home-Based OCT for Retina Patients

A home-based OCT platform could help detect fluid recurrence or progression between visits, providing patients and physicians with vital knowledge about disease ...

Pivotal Trial Validating Usability and Visualization ...

Recent studies of a patient using the self-installed and self-operated spectral-domain OCT system from the same manufacturer demonstrated highly successful ...

Pivotal Trial Toward Effectiveness of Self-administered OCT in ...

Results. Self-imaging was performed successfully by 387 participants in 2451 of 2616 attempts (93.7%). For repeatability, the coefficient of ...

Notal Vision Home Optical Coherence Tomography (OCT ...

Upon self-imaging, images are automatically and securely transmitted to the Notal Health Cloud for viewing by the prescribing user. Raw data are.

SCANLY® Home OCT

96% of all participants were able to successfully obtain OCT images at home. The participants performed a total of 5,426 scans in the study eye, with 98% of all ...

Daily Self-Imaging with Patient-Operated Home OCT in ...

Several outcome measures were used. The first was daily self-imaging completion, that is, the proportion of OCT scans successfully performed, transmitted, and ...