OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits (DME FOUND)

November 22, 2017 updated by: Joslin Diabetes Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

385

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
      • Wellfleet, Massachusetts, United States, 02667
        • OuterCape Health Services, Inc
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • University of Endocrine Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCT imaging
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
Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Retina Care Referral for Patients With Diabetic Macular Edema
Time Frame: 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
Baseline visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal Referral Rates for Patients With DME
Time Frame: 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
Baseline visit
Rates of Retinal Treatment for Patients With DME
Time Frame: 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
One month
Rates of Retinal Treatment Over 1 Year for Patients With DME
Time Frame: 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
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Collaborators

Juvenile Diabetes Research Foundation
Genentech, Inc.
Optovue

Investigators

  • Principal Investigator: Jennifer K Sun, MD, Joslin Diabetes Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2014

Primary Completion (Actual)

May 14, 2015

Study Completion (Actual)

July 15, 2016

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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