OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits
Completed · Not applicable
Conditions studied: Diabetes, Diabetic Macular Edema, Diabetic Retinopathy
In brief
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.
Key facts
- Study ID
- NCT01875783
- Run by
- Joslin Diabetes Center
- People needed
- 385
- Starts
- 2014-03-17
- Expected to finish
- 2016-07-15
- Last updated by the study team
- 2017-12-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Joslin Diabetes Center — Boston, Massachusetts, United States
- OuterCape Health Services, Inc — Wellfleet, Massachusetts, United States
- SUNY Upstate Medical University — Syracuse, New York, United States
- University of Endocrine Consultants — Chattanooga, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.