Diabetic Macular Edema Severity at Diagnosis

Study Overview
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Brief Summary
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The purpose of this study is to identify the severity level distribution at the moment of diagnosis, in diabetic patients with macular edema from a Mexico City sample, and to identify the rate with severe macular edema that needed immediate treatment.

Detailed Description
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The international severity scale grades macular edema as mild, moderate or severe, according to the distance of the thickening from the center of the fovea; However, this scale does not define the distances which fulfill the criteria of distant from or approaching the center of the macula; a quantitative and reproducible tool, such as optical coherence tomography (OCT), could be more accurate to grade severity, by localizing thickening in a standardized way. As far as we know, distribution of clinically significant macular edema at the moment of diagnosis, according to the international scale has not been described. A study was conducted to identify the rate of eyes that had severe macular edema at the moment of diagnosis, whose risk of visual loss could be higher and required immediate treatment.

Official Title
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Distribution of Macular Edema Severity Level at the Moment of Diagnosis

Conditions
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Diabetes Mellitus, Diabetic Retinopathy, Macular Edema

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetic regardless of diabetes duration and retinopathy severity level one or both eyes with CSME Exclusion Criteria: media opacities that prevented an adequate fast macular map from being acquired a thickened posterior vitreous any additional retinal disease

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diabetic macular edema<br>Type 2 diabetes patients who had clinically significant macular edema by the criterion of the ETDRS | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickening measured by optical coherence tomography in 3 zones: central subfield (when field 1 was thickened), inner ring (when any of fields 2, 3, 4 or 5 was thickened), and inner ring or outer ring (when any of fields 6, 7, 8, or 9 was thickened) |  | at the diagnosis moment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity level: adaptation of International clinical diabetic macular edema severity scale to fields of the OCT; mild if thickening exclusively involved outer-ring, moderate if was in inner-ring without involvement field 1, and severe if was in field 1 |  | at the diagnosis moment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinically Significant Macular Edema, Diabetic Macular Edema, Optical Coherence Tomography, Diabetic Retinopathy, Severity