Diabetic Macular Edema Severity at Diagnosis

Hospital Juarez de Mexico

Status: Completed

Conditions: Macular Edema; Diabetes Mellitus; Diabetic Retinopathy

Study type: Observational

Funder types: Other

Identifiers

NCT00886392

HJM 1449/08.02.13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

118 participants in 1 patient group

diabetic macular edema

Description:

Type 2 diabetes patients who had clinically significant macular edema by the criterion of the ETDRS