Status:
COMPLETED
OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits
Lead Sponsor:
Joslin Diabetes Center
Collaborating Sponsors:
Genentech, Inc.
Juvenile Diabetes Research Foundation
Conditions:
Diabetes
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
NA
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 inc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2016
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT01875783
Start Date
March 17 2014
End Date
July 15 2016
Last Update
December 22 2017
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
2
OuterCape Health Services, Inc
Wellfleet, Massachusetts, United States, 02667
3
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
4
University of Endocrine Consultants
Chattanooga, Tennessee, United States, 37411