OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits

Study Overview
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Brief Summary
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The purpose of this protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral algorithm will enable identification of patients at risk for vision loss from diabetic macular edema and facilitate direct referral to retina specialists for more timely evaluation and treatment.

Official Title
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Diabetic Macular Edema Found by OCT Utilization at Non-ophthalmic Diabetes Care Visits

Conditions
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Diabetes, Diabetic Macular Edema, Diabetic Retinopathy

Intervention / Treatment
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* Device: OCT imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 or type 2 diabetes mellitus as evidenced by: Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR Documented diabetes by American Diabetes Association and/or World Health Organization criteria Age greater than or equal to 18 years old Diabetes duration of 10 more years OR last measured HbA1c of 10% or more Able and willing to participate in study procedures and comply with study follow-up visits Able to give informed consent for study participation Not moving out of the study area during the 1 year follow-up period Exclusion Criteria: Unable to cooperate with the OCT image acquisition procedure or other study procedures Unable or unwilling to comply with the study follow-up visits Unable or unwilling to sign form for release of retinal medical records

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT imaging<br>All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status. | Device: OCT imaging<br>* Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Retina Care Referral for Patients With Diabetic Macular Edema | Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm | Baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Referral Rates for Patients With DME | Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm | Baseline visit | 
| Rates of Retinal Treatment for Patients With DME | Percentage of participants are referred by OCT-guided algorithm who are confirmed to have vision threatening retinopathy at first visit with retina specialist after study enrollment | One month | 
| Rates of Retinal Treatment Over 1 Year for Patients With DME | Percentage of participants who are referred by OCT guided algorithm to a retina specialist who receive treatment for DME over the course of 9 months follow-up by retina specialist | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, diabetic macular edema, diabetic retinopathy, optical coherence tomography