Diabetic Macular Edema Severity at Diagnosis
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.
|Study Design:||Observational Model: Ecologic or Community
Time Perspective: Prospective
|Official Title:||Distribution of Macular Edema Severity Level at the Moment of Diagnosis|
- 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) [ Time Frame: at the diagnosis moment ] [ Designated as safety issue: Yes ]
- 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 [ Time Frame: at the diagnosis moment ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
diabetic macular edema
Type 2 diabetes patients who had clinically significant macular edema by the criterion of the ETDRS
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886392
|Hospital Juarez de Mexico|
|Mexico, Distrito Federal, Mexico, 07760|
|Principal Investigator:||Patricia Muñoz Ibarra, MD||Hospital Juarez de Mexico|
|Study Director:||Dulce M Razo Blanco Hernandez, MD||Hospital Juarez de Mexico|
|Study Chair:||Virgilio Lima Gomez, MD, MsC||Hospital Juarez de Mexico|