OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Retinal Referral Rates for Patients With DME	Baseline visit	Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm
Rates of Retinal Treatment Over 1 Year for Patients With DME	9 months	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
Rates of Retinal Treatment for Patients With DME	One month	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

Locations (4): Joslin Diabetes Center
🇺🇸
Boston, Massachusetts, United States
OuterCape Health Services, Inc
🇺🇸
Wellfleet, Massachusetts, United States
SUNY Upstate Medical University
🇺🇸
Syracuse, New York, United States
University of Endocrine Consultants
🇺🇸
Chattanooga, Tennessee, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States