OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits



Status:Completed
Conditions:Cardiology, Ocular, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:12/24/2017
Start Date:March 17, 2014
End Date:July 15, 2016

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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.


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
We found this trial at
4
sites
Chattanooga, Tennessee 37411
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Chattanooga, TN
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One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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Boston, MA
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750 East Adams Street
Syracuse, New York 13210
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Syracuse, NY
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Wellfleet, Massachusetts 02667
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Wellfleet, MA
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