OSNAT 800 IO for Diabetic Retinopathy

SC
Overseen ByStudy Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: PulseMedica
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 eye imaging technology for people with diabetic retinopathy, a condition that can lead to vision loss. The goal is to determine if the OSNAT 800 IO device can successfully track eye movements in real-time while capturing 3D images of the eye. People diagnosed with diabetic retinopathy who have clear vision in both eyes might be suitable candidates for this study. It offers a chance to contribute to the development of better methods for monitoring and managing eye health. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance eye care for many.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the OSNAT 800 IO device is safe for retinal imaging?

Research has shown that the OSNAT 800 IO device is being tested to capture 3D images of the eye and track eye movements in real time for individuals with diabetic retinopathy, a condition that can lead to vision loss. This study focuses on verifying the device's functionality rather than its safety in the traditional sense.

Specific safety data for the OSNAT 800 IO device from previous studies is not available. However, similar devices generally pose a low risk because they are non-invasive, meaning they do not involve surgery or entering the body. Most individuals experience little to no discomfort during eye imaging.

Since the trial does not involve testing a new drug or surgery, and based on the performance of similar devices, it is reasonable to consider the OSNAT 800 IO likely safe and well-tolerated. Participants will have their eyes imaged with the device during a regular care appointment, indicating that any risk is minimal.12345

Why are researchers excited about this trial?

Researchers are excited about the OSNAT 800 IO because it offers a real-time eye tracking and imaging solution for diabetic retinopathy patients, which could provide more immediate and precise monitoring compared to standard imaging methods like fundus photography or optical coherence tomography. Unlike existing treatments that focus on managing symptoms or slowing disease progression, this device enhances diagnostic capabilities by capturing detailed images during routine eye exams. This advancement could lead to earlier detection of changes in the eye, allowing for timely interventions and potentially better outcomes for patients.

What evidence suggests that the OSNAT 800 IO is effective for real-time eye tracking in diabetic retinopathy?

Research shows that the OSNAT 800 IO, used by participants in this trial, is a promising tool for diabetic retinopathy. This device captures 3D images of the eye and tracks eye movements in real-time. Early results suggest it excels at capturing detailed images of the retina. It may help identify early changes in the eyes of people with diabetes, potentially improving monitoring and treatment planning. However, further studies are needed to confirm its effectiveness in reducing vision loss.12467

Are You a Good Fit for This Trial?

Inclusion Criteria

Male or female
Diagnosed diabetic retinopathy
Two eyes with clear ocular media

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retinal Imaging

Participants undergo retinal imaging using the OSNAT800 IO device to assess real-time eye tracking capabilities

Single session
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • OSNAT 800 IO
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Retinal Imaging using the OSNAT800 IO deviceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

PulseMedica

Lead Sponsor

Trials
3
Recruited
340+

Citations

Real-time Eye Tracking and Imaging of the Eye in Diabetic ...This trial is testing a new camera called the OSNAT800 IO that takes 3D pictures of the back of the eye and tracks eye movements in real-time.
OSNAT 800 IO in Diabetic Retinopathy and Retinal ImagingThe purpose of this study is to assess the feasibility of PulseMedica's prototype device, the OSNAT800 Imaging Only (IO), in providing real-time ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40674746/
Performance of a Retinal Imaging Camera With On-Device ...Our findings about the performance and usability of this retinal camera system support its deployment as an integrated end-to-end retinal ...
Early detection of dementia through retinal imaging and ...Using 5751 OCTA images from 1671 participants in a multi-center study, our model demonstrated superior performance in EOAD (internal data: AUC = 0.9355, ...
Guidelines for the use and interpretation of assays for ... - I.R.I.S.... Osnat Ashur-Fabian,. Atanas G. Atanasov, Alicia K. Au, Patrick ... Published online: 08 Feb 2021. Submit your article to this journal. Article ...
Patient perspectives on artificial intelligence in healthcareData extraction focused on study characteristics, AI applications, healthcare domains, and patient-reported perceptions organized into thematic categories.
Balancing Benefits and Risks: The Case for Retinal Images ...Retinal images have benefits for research, but HIPAA protects patient privacy. The Academy concludes the risk of re-identification is low, and ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security