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OpenTrials
Completed

NCT Number: NCT01875783

OCT Screening for Diabetic Macular Edema at Primary 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.

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Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Macular Edema Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OCT imaging

Device

Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Genentech, Inc.
  • Juvenile Diabetes Research Foundation
  • Optovue

Registry information

Official study title

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

Acronym: DME FOUND

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 12, 2013
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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