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OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits

NCT01875783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2017-12-22

Study results available
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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.

Conditions

Interventions

DEVICE

OCT imaging

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

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Optovue

    collaborator INDUSTRY

  • Joslin Diabetes Center

    lead OTHER

Principal Investigators

  • Jennifer K Sun, MD · Joslin Diabetes Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-17
Primary Completion
2015-05-14
Completion
2016-07-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01875783 on ClinicalTrials.gov