Diabetic Macular Edema Severity at Diagnosis

Completed

• Conditions: Diabetes Mellitus; Diabetic Retinopathy; Macular Edema

• Registration Number: NCT00886392
• Lead Sponsor: Hospital Juarez de Mexico

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2007-12
• Study Completion: 2008-04
• Status Verified: 2009-04
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Last Update Submitted: 2009-04-21
• Study First Posted: 2009-04-22
• Last Update Posted: 2009-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Juarez de Mexico; 🇲🇽 Mexico, Distrito Federal, Mexico