NCT00886392

Diabetic Macular Edema Severity at Diagnosis

Distribution of Macular Edema Severity Level at the Moment of Diagnosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 118 (actual)
• Sponsor: Hospital Juarez de Mexico · Other Government
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Diabetic Retinopathy
• Macular Edema

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-12-01
• Completion: 2008-04-01
• First posted: 2009-04-22
• Last updated: 2009-04-22

Locations

1 site across 1 country: Mexico