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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01875783
Recruitment Status : Completed
First Posted : June 12, 2013
Results First Posted : September 20, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
Genentech, Inc.
Juvenile Diabetes Research Foundation
Optovue
Information provided by (Responsible Party):
Joslin Diabetes Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetic Macular Edema Diabetic Retinopathy Device: OCT imaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 385 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Investigator)
Masking Description: Primary diabetes care specialists masked to results of OCT intervention
Primary Purpose: Diagnostic
Official Title: Diabetic Macular Edema Found by OCT Utilization at Non-ophthalmic Diabetes Care Visits
Actual Study Start Date : March 17, 2014
Actual Primary Completion Date : May 14, 2015
Actual Study Completion Date : July 15, 2016

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875783


Locations
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United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
OuterCape Health Services, Inc
Wellfleet, Massachusetts, United States, 02667
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, Tennessee
University of Endocrine Consultants
Chattanooga, Tennessee, United States, 37411
Sponsors and Collaborators
Joslin Diabetes Center
Genentech, Inc.
Juvenile Diabetes Research Foundation
Optovue
Investigators
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Principal Investigator: Jennifer K Sun, MD Joslin Diabetes Center
More Information
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Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01875783    
Other Study ID Numbers: 2011-17
First Posted: June 12, 2013    Key Record Dates
Results First Posted: September 20, 2017
Last Update Posted: December 22, 2017
Last Verified: November 2017
Keywords provided by Joslin Diabetes Center:
diabetes
diabetic macular edema
diabetic retinopathy
optical coherence tomography
Additional relevant MeSH terms:
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Macular Edema
Retinal Diseases
Diabetic Retinopathy
Diabetes Mellitus
Edema
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications