OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits

Diabetes Clinical Trial

— DME FOUND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875783
• Other study ID #: 2011-17
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: November 22, 2017
• Start date: March 17, 2014
• Est. completion date: July 15, 2016

Study information

• Verified date: November 2017
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: July 15, 2016
• Est. primary completion date: May 14, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	University of Endocrine Consultants	Chattanooga	Tennessee
United States	SUNY Upstate Medical University	Syracuse	New York
United States	OuterCape Health Services, Inc	Wellfleet	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Genentech, Inc., Juvenile Diabetes Research Foundation, Optovue

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of Retina Care Referral for Patients With Diabetic Macular Edema	Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm	Baseline visit
Secondary	Retinal Referral Rates for Patients With DME	Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm	Baseline visit
Secondary	Rates of Retinal Treatment for Patients With DME	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	One month
Secondary	Rates of Retinal Treatment Over 1 Year for Patients With DME	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	9 months