Teleophthalmology for Diabetic Retinopathy

Overseen By Yao Liu, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Non-rural population, High screening rate

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called I-SITE, which aims to boost eye screening for people with diabetes using teleophthalmology (remote eye exams via technology) in rural areas. The goal is to ensure more people with diabetes receive regular eye check-ups to prevent vision problems. The trial seeks rural health systems that already use teleophthalmology but can improve their screening rates. Health systems serving rural patients and able to share anonymous patient information at set times are a good fit for this trial. As an unphased trial, this study offers a unique opportunity to enhance healthcare access and outcomes for rural communities.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the I-SITE implementation program is safe for diabetic eye screening?

Research has shown that teleophthalmology, such as the I-SITE program, effectively increases eye screenings for people with diabetes. This method uses technology to detect eye problems caused by diabetes, helping to prevent blindness. Many places use teleophthalmology, and it is generally safe because it involves only taking pictures of the eyes and examining them remotely. No major safety issues have been reported with this method. It provides a simple, non-invasive way to ensure more people receive necessary eye care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about I-SITE for diabetic retinopathy because it offers a unique approach to eye care by using teleophthalmology in rural health systems. Unlike traditional care that relies heavily on in-person visits, I-SITE leverages technology to bring specialized eye screenings to remote areas, which can significantly improve access and early detection of diabetic retinopathy. This method could bridge the gap in healthcare disparities and ensure more people get the eye care they need without long travel distances.

What evidence suggests that the I-SITE program is effective for increasing diabetic eye screening rates?

Research shows that the I-SITE program, which participants in this trial will experience, can increase eye screenings for people with diabetes by using teleophthalmology, or eye care through telemedicine. Past studies found that I-SITE led to more screenings in rural health areas. This is crucial because early detection of diabetic retinopathy, an eye problem related to diabetes, can prevent vision loss. Although evidence about telemedicine's overall effect in the U.S. remains limited, I-SITE has shown promise in encouraging more people to complete screenings. With I-SITE, more patients receive necessary screenings, marking a positive step toward better eye health for those with diabetes. ^{2 5 6 7 8}

Who Is on the Research Team?

Yao Liu, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for rural health systems that already have a teleophthalmology program for diabetic eye screening but with less than 50% screening rates. These systems must serve patients in areas defined as rural and agree to share de-identified patient data.

Inclusion Criteria

Health system agrees to share de-identified patient data at the requested time intervals

My health system offers diabetic eye screening via telehealth.

Health system serves rural patients as defined as those patients living in counties considered rural by the federal Office of Management and Budget (OMB)

Exclusion Criteria

Health system does not serve a rural patient population

Health system has a diabetic eye screening rate of greater than 50% (e.g., above the national average) as it may limit the ability to measure improvement from I-SITE

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

I-SITE Implementation

Implementation of the I-SITE program to increase diabetic eye screening rates using teleophthalmology

24 months

Series of 2 in-person meetings, 10 monthly teleconferences, and 4 quarterly group teleconferences

Follow-up

Participants are monitored for changes in diabetic eye screening rates and follow-up rates for in-person eye care

24 months

Long-term Follow-up

Continued monitoring of diabetic eye screening rates and follow-up rates for in-person eye care

48 months

What Are the Treatments Tested in This Trial?

Interventions

• I-SITE

Trial Overview The I-SITE program aims to improve diabetic eye screening rates using teleophthalmology in rural health settings. The study will involve up to 10,000 patients and 100 clinical staff across multiple sites over a period of up to 48 months.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Up to 10 rural health systems will be participating in I-SITE implementation with cluster-randomization of the order of initiation for the intervention. All sites will receive usual care teleophthalmology prior to I-SITE implementation.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

A systematic review of 14,866 intravitreous injections showed that the risk of serious adverse events, particularly endophthalmitis, is low, with a prevalence of 0.3% per injection and 0.9% per eye.

Despite the low overall risk, careful injection technique and post-injection monitoring are crucial, as rare complications can lead to permanent vision loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risks of intravitreous injection: a comprehensive review. Jager, RD., Aiello, LP., Patel, SC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8258481/

Implementation for Sustained Impact in Teleophthalmology ... Data on strategies that increased provider teleophthalmology use complements our clinical outcomes demonstrating that I-SITE effectively ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05254535

I-TRUST: Implementation of Teleophthalmology in Rural ... The primary outcome measure will be the change in diabetic eye screening rates between baseline and 24 months after initiation of I-SITE implementation.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10018958/

Effectiveness of telemedicine diabetic retinopathy ... There is limited evidence on whether using telemedicine to screen for DR in primary care clinics in the USA effectively leads to increased DR screening rates.

4. hipxchange.org hipxchange.org/toolkit/i-site/

A Guide to Implementation for Sustained Impact in ... This toolkit is intended for primary care clinics seeking to achieve and sustain increased diabetic eye screening rates using teleophthalmology.

5. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(25)00233-7/fulltext

Autonomous Artificial Intelligence in Diabetic Retinopathy ... From 2019 to 2021, the overall adherence rate increased from 42.6% to 55.5% at AI sites (1949 patients) and increased from 38.0% to 41.0% at non ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9398488/

Teleophthalmology and Inequities in Diabetic Eye Disease ... This study compared the rates and severity of diabetic eye disease, as detected by teleophthalmology, between safety net and non-Safety Net Hospitals (non-SNHs ...

7. nature.com nature.com/articles/s41433-025-04071-y

Persistent disparities in diabetic retinopathy outcomes ... Outcomes included incident DR, sight-threatening complications, ophthalmic treatment and diagnostics, and documented treatment nonadherence. Cox ...

8. diabetesjournals.org diabetesjournals.org/care/article/47/6/930/156717/Measuring-Outcomes-of-Diabetic-Retinopathy

Measuring Outcomes of Diabetic Retinopathy Screening This was despite reporting that their last eye exam was within 2 years (86%), within 12 months (62%), within 6 months (40%), and within 3 months ...