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

Trial Summary

What is the purpose of this trial?

This pragmatic clinical trial 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 rural, multi-payer health systems. Up to 10 rural health systems providing teleophthalmology to 10,000 patients with diabetes and 100 clinical care personnel participating in the I-SITE intervention will be enrolled for up to 48 months.

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 data supports the effectiveness of the treatment I-SITE for diabetic retinopathy?

The studies show that teleophthalmology, which involves using technology to assess eye health remotely, is effective in screening for diabetic retinopathy. This suggests that treatments like I-SITE, which may use similar technology, could be effective in managing diabetic eye conditions. ^{1 2 3 4 5}

Is teleophthalmology safe for humans?

The studies on teleophthalmology for diabetic retinopathy focus on screening and do not report any specific safety concerns, suggesting it is generally safe for use in humans. ^{1 6 7 8 9}

How is the I-SITE treatment for diabetic retinopathy different from other treatments?

The I-SITE treatment uses teleophthalmology, which allows for remote screening and diagnosis of diabetic retinopathy through digital imaging, making it more accessible for patients in rural or underserved areas compared to traditional in-person eye exams. ^{1 2 10 11 12}

Research Team

Yao Liu, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

My health system offers diabetic eye screening via telehealth.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

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

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

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

3. 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]

4. 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]

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

Real-Time Ultrawide Field Image Evaluation of Retinopathy in a Diabetes Telemedicine Program. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

A protocol for the retina surgeon's safe initial intravitreal injections. [2021]

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

Risks of intravitreous injection: a comprehensive review. [2022]

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

Teleophthalmology screening for diabetic retinopathy through mobile imaging units within Canada. [2022]

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

Evaluation of remote assessment reliability in the follow-up of patients with diabetic macular edema. [2022]

10. England pubmed.ncbi.nlm.nih.gov

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

11. Canada pubmed.ncbi.nlm.nih.gov

Assessment of Training Outcomes of Nurse Readers for Diabetic Retinopathy Telescreening: Validation Study. [2020]

12. India pubmed.ncbi.nlm.nih.gov

Telemedicine in diabetic retinopathy: Access to rural India. [2018]