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OCT Screening for Diabetic Macular Edema at Primary Diabetes Care Visits

NCT ID: NCT01875783

Last Updated: 2017-12-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-17

Study Completion Date

2016-07-15

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetic Macular Edema Diabetic Retinopathy

Keywords

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diabetes diabetic macular edema diabetic retinopathy optical coherence tomography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Investigators
Primary diabetes care specialists masked to results of OCT intervention

Study Groups

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OCT imaging

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.

Group Type EXPERIMENTAL

OCT imaging

Intervention Type DEVICE

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

Interventions

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OCT imaging

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role collaborator

Optovue

INDUSTRY

Sponsor Role collaborator

Joslin Diabetes Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer K Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Locations

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Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

OuterCape Health Services, Inc

Wellfleet, Massachusetts, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

University of Endocrine Consultants

Chattanooga, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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2011-17

Identifier Type: -

Identifier Source: org_study_id