OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits (DME FOUND)

Joslin Diabetes Center

Status: Completed

Conditions: Diabetes; Diabetic Macular Edema; Diabetic Retinopathy

Treatments: Device: OCT imaging

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01875783

2011-17

Details and patient eligibility

About

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.

Enrollment: 385 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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385 participants in 1 patient group

OCT imaging

Experimental group

Description:

All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.

Treatment:

Device: OCT imaging