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

2000 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment I-SITE Intervention, Usual Care Teleophthalmology for diabetic retinopathy?

Research shows that teleophthalmology, which uses technology to screen for eye diseases like diabetic retinopathy, is effective in identifying these conditions in various settings, such as rural areas in Alberta and Kenya. This approach allows for early detection and management without needing in-person visits, making it a practical and efficient option for patients. ^{1 2 3 4 5}

How is the I-SITE Intervention treatment for diabetic retinopathy unique?

The I-SITE Intervention uses teleophthalmology, which allows for remote screening and monitoring of diabetic retinopathy, making it accessible for patients in rural or underserved areas. This approach differs from traditional in-person eye exams by using digital imaging to assess eye health, potentially increasing early detection and treatment opportunities. ^{1 4 6 7 8}

What is the purpose of this trial?

This study is being conducted to test the effectiveness of I-SITE (Implementation for Sustained Impact in Teleophthalmology), an implementation program to sustain increased diabetic eye screening rates using teleophthalmology in urban, multi-payer health systems.

Research Team

Yao Liu, MD, MS

Principal Investigator

UW School of Medicine and Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

The prevalence of diabetic retinopathy as identified by teleophthalmology in rural Alberta. [2019]

2. India pubmed.ncbi.nlm.nih.gov

The Muranga Teleophthalmology Study: A Comparison of Virtual (Teleretina) Assessment with in-person Clinical Examination to Diagnose Diabetic Retinopathy and Age-related Macular Degeneration in Kenya. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

SMARTPHONE-BASED DILATED FUNDUS PHOTOGRAPHY AND NEAR VISUAL ACUITY TESTING AS INEXPENSIVE SCREENING TOOLS TO DETECT REFERRAL WARRANTED DIABETIC EYE DISEASE. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Eight years' experience in mobile teleophthalmology for diabetic retinopathy screening. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Development of a store-and-forward telescreening system of diabetic retinopathy: lessons learned from Iran. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Diabetic Retinopathy Assessment Variability Among Eye Care Providers in an Urban Teleophthalmology Program. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Implementation of Teleophthalmology to Improve Diabetic Retinopathy Surveillance: Qualitative Interview Study of Clinical Staff Informed by Implementation Science Frameworks. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Identification of diabetic retinopathy by stereoscopic digital imaging via teleophthalmology: a comparison to slide film. [2019]