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Teleophthalmology for Diabetic Retinopathy

N/A
Waitlist Available
Led By Yao Liu, MD, MS
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months, 36 months, 48 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if an implementation program can increase diabetic eye screening rates using teleophthalmology in rural health systems, with 10 systems and 10,000 patients taking part.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on the implementation of a service (teleophthalmology) rather than a medical treatment, traditional side effects are not applicable. However, there may be technical issues or challenges in data management.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months, 36 months, 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months, 36 months, 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Patients Who Complete Annual Diabetic Eye Screening
Secondary study objectives
Change in Proportion of Patients Who Complete Annual Diabetic Eye Screening
Eye
Identification of workflow strategies, organizational factors, and implementation components that distinguish between health systems with high and low teleophthalmology use
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,234 Previous Clinical Trials
3,200,281 Total Patients Enrolled
5 Trials studying Diabetic Retinopathy
9,762 Patients Enrolled for Diabetic Retinopathy
National Eye Institute (NEI)NIH
556 Previous Clinical Trials
1,407,460 Total Patients Enrolled
50 Trials studying Diabetic Retinopathy
42,835 Patients Enrolled for Diabetic Retinopathy
Yao Liu, MD, MSPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
3,526 Total Patients Enrolled
2 Trials studying Diabetic Retinopathy
3,526 Patients Enrolled for Diabetic Retinopathy

Media Library

I-SITE Clinical Trial Eligibility Overview. Trial Name: NCT05254535 — N/A
Diabetic Retinopathy Research Study Groups: Intervention
Diabetic Retinopathy Clinical Trial 2023: I-SITE Highlights & Side Effects. Trial Name: NCT05254535 — N/A
I-SITE 2023 Treatment Timeline for Medical Study. Trial Name: NCT05254535 — N/A
~5 spots leftby Dec 2026