Teleophthalmology for Diabetic Retinopathy

Overseen By Yao Liu, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of an eye care program called I-SITE, a teleophthalmology intervention, in the early detection of diabetic retinopathy. This common eye condition in people with diabetes can lead to vision loss. The study will test whether teleophthalmology (remote eye exams) can increase the rate of eye screenings in urban health systems. Individuals with either type 1 or type 2 diabetes who regularly undergo eye exams might be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance eye care for many.

Will I have to stop taking my current medications?

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

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

Research has shown that the I-SITE program, which conducts remote eye exams through technology, is safe for patients. One study found that using a special camera to photograph the back of the eye without eye drops was both safe and effective for diabetic eye exams. This method, tested in young patients, yielded good results. No major side effects were reported, indicating the treatment was well-tolerated. This suggests that I-SITE, which uses similar technology, is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-SITE Intervention for diabetic retinopathy because it leverages teleophthalmology to improve access to eye care. Unlike traditional methods that often require in-person visits to a specialist, this approach enables remote screening and monitoring, making it more convenient for patients, especially those in underserved areas. The use of teleophthalmology could lead to earlier detection and treatment of diabetic retinopathy, potentially improving outcomes and reducing the risk of vision loss. This innovative method aims to bridge the gap in care accessibility and efficiency.

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

Research has shown that the I-SITE Intervention, which participants in this trial may receive, can successfully increase the number of people obtaining eye exams for diabetes through teleophthalmology, a method that uses technology to provide remote eye care. One study found that the number of people completing their diabetic eye exams was significantly higher, reaching up to 100% in the group using the intervention, compared to those who did not. Other reports indicate that screening rates increased to between 74.8% and 90.3% among patients who were contacted. Regular eye exams are crucial because they can help prevent blindness caused by diabetes. The I-SITE program aims to make these essential eye exams more accessible. ^{1 5 6 7 8}

Who Is on the Research Team?

Yao Liu, MD, MS

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for individuals with type 1 or type 2 diabetes who are part of an urban health system and have had diabetic eye screenings. Participants' medical records must include specific ICD-10 codes for diabetes and billing data for teleophthalmology services.

Inclusion Criteria

Billing data will be identified using teleophthalmology (CPT codes 92228 or 92250)

Eligible medical records will be identified using ICD-10 codes for diabetes type 1 or type 2

Identification of eligible records will be performed by clinic personnel at each health system who already have full access to their patient data as part of their employment, and regularly gather and report this type of data to health insurers as part of their clinical role

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care Teleophthalmology

All sites receive usual care teleophthalmology with access to the I-SITE online toolkit and use of non-mydriatic retinal cameras for diabetic eye screening.

6 weeks

1 visit (in-person), ongoing access to toolkit

I-SITE Intervention

Implementation of the I-SITE program including webinars, in-person meetings, and teleconferences to integrate teleophthalmology into primary care workflows.

10 months

1 webinar, 2 in-person meetings, 10 teleconferences

Follow-up

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

24 months

What Are the Treatments Tested in This Trial?

Interventions

• I-SITE Intervention
• Usual Care Teleophthalmology

Trial Overview The study tests the I-SITE program's effectiveness in maintaining high rates of diabetic eye screening through teleophthalmology, compared to usual care, within urban health systems that cater to multiple insurance payers.

How Is the Trial Designed?

Group I: Usual Care Followed by I-SITE Intervention Experimental Treatment 2 Interventions

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+

Citations

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

Implementation for Sustained Impact in Teleophthalmology ... Long-term Comparative Effectiveness of Telemedicine in Providing Diabetic Retinopathy Screening Examinations: A Randomized Clinical Trial.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8558054/

Sustaining Gains in Diabetic Eye Screening Diabetic Eye Screening Rates ... Survey response rates between 2015 and 2019 ranged from 74.8% to 90.3% among patients whom we were able to contact and 39.5–60.2% ...

3. diabetesjournals.org diabetesjournals.org/care/article/48/11/1914/163381/Quantifying-Barriers-to-Diabetic-Eye-Screening-A

Quantifying Barriers to Diabetic Eye Screening: A Two-Center ... The main study outcomes included screening referral and completion, diabetic retinopathy diagnosis (within 1 year), and treatment (within 2 ...

4. nature.com nature.com/articles/s41467-023-44676-z

Autonomous artificial intelligence increases screening and ... Diabetic eye exam completion rate was significantly higher (100%, 95%CI: 95.5%, 100%) in the intervention group (n = 81) than the control group ...

5. med.wisc.edu med.wisc.edu/news/study-to-expand-rural-diabetic-eye-screening/

New study seeks to expand eye screenings for rural diabetic ... “Regular eye screening and early treatment makes it much more likely that we can prevent blindness from diabetes, preserving a patient's vision.

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840380

Diabetic Retinopathy Screening Among Federally Qualified ... Data will be checked for normality of distribution prior to analysis. If assumptions are violated, appropriate transformations will be applied.

7. diabetesjournals.org diabetesjournals.org/care/article/44/3/781/138584/The-SEE-Study-Safety-Efficacy-and-Equity-of

The SEE Study: Safety, Efficacy, and Equity of Implementing ... Use of a nonmydriatic fundus camera with autonomous AI was safe and effective for the diabetic eye exam in youth in our study.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12541539/

Diabetic Retinopathy Screening Among Federally Qualified ... Data will be checked for normality of distribution prior to analysis. If assumptions are violated, appropriate transformations will be applied.