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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Juvenile Diabetes Research Foundation | OTHER |
| Optovue | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT imaging | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT imaging | Device | Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rates of Retinal Treatment for Patients With DME |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer K Sun, MD | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States | ||
| OuterCape Health Services, Inc |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Baseline visit |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Sun | Joslin Diabetes Center | 617-209-2554 | jennifer.sun@joslin.harvard.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Primary diabetes care specialists masked to results of OCT intervention
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 |
| 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 |
| Wellfleet |
| Massachusetts |
| 02667 |
| United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| University of Endocrine Consultants | Chattanooga | Tennessee | 37411 | United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | Posted | Count of Units | eyes | Baseline visit | eyes | eyes |
|
|
|
| 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 | This is the subgroup of participants who were referred for retinal care by the OCT guided referral algorithm | Posted | Count of Participants | Participants | 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 | This is the subgroup of participants who were referred for retina care by the OCT guided referral algorithm. | Posted | Count of Participants | Participants | 9 months |
|
|
|
| 0 |
| 385 |
| 0 |
| 385 |
| 0 |
| 385 |
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| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |