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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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This longitudinal interventional case series will utilize the patients at the University of Michigan W.K. Kellogg Eye Center scheduled to begin treatment for diabetic macular edema. Baseline measures will be taken which include structural assessments such as circulatory capacity utilizing fluorescein angiography, in addition to retinal layer integrity and thickness using high resolution optical coherence tomography. Also, functional assessments such as visual acuity, contrast sensitivity, photostress recovery, dark adaptation, perimetry, and cellular fluorescence will be tested. Adverse events will be recorded and compared with historical controls to ensure that currently accepted interventions are safe. Finally, potential confounding variables for DME including those related to the eye, systemic factors, and patient demographics will be recorded to assess the influence of these variables on treatment response.
The primary objective is to develop hypotheses that might better explain the retinal structural (anatomical) and/or functional (physiological) mechanisms of visual impairment in eyes receiving treatment for diabetic macular edema (DME).
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| Measure | Description | Time Frame |
|---|---|---|
| Dark adaptation (AdaptRx) | Rod intercept (minutes) | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Optical coherence tomography | Thickness of nerve fiber layer and ganglion cell layer, volume of intraretinal cysts, volume of subretinal fluid, central subfield thickness, thickness of choroid (enhanced depth imaging), status of vitreoretinal interface, presence of epiretinal membrane, status of inner segment/outer segment junction | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescein angiography | Fluorescein transit time, foveal avascular zone (FAZ) greatest linear dimension, FAZ area, presence of perifoveal capillary loss, area of dye leakage, and microaneurysm density | 12 months |
| Lipofuscin fundus autofluorescence |
Inclusion Criteria:
Exclusion Criteria:
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Individuals undergoing treatment for diabetic macular edema at the University of Michigan W.K. Kellogg Eye Center.
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| Name | Affiliation | Role |
|---|---|---|
| Grant Comer, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
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Index of retinal autofluorescence
| 12 Months |
| Color photographs | Diabetic Retinopathy Disease Severity Scale | 12 Months |
| Frequency Doubling Threshold visual field | Mean deviation, pattern standard deviation | 12 Months |
| Contrast sensitivity | Log contrast sensitivity | 12 Months |
| Photostress test | 12 Months |
| Flavoprotein fluorescence | Index of metabolic fluorescence, average intensity (grey scale unit (gsu)), average curve width (GSU), heterogeneity score | 12 Months |