OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits

Joslin Diabetes Center385 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

385

Conditions

Diabetes Diabetic Macular Edema Diabetic Retinopathy

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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

Time frame: Baseline visit

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 9 months