Diabetic Macular Edema Severity at Diagnosis

NCT ID: NCT00886392

Last Updated: 2009-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 118 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-04-30

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.

Conditions

Diabetes Mellitus; Diabetic Retinopathy; Macular Edema

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

diabetic macular edema

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Juarez de Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hospital Juarez de Mexico

Principal Investigators

Patricia Muñoz Ibarra, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Juarez de Mexico

Dulce M Razo Blanco Hernandez, MD

Role: STUDY_DIRECTOR

Hospital Juarez de Mexico

Virgilio Lima Gomez, MD, MsC

Role: STUDY_CHAIR

Hospital Juarez de Mexico

Locations

Hospital Juarez de Mexico

Mexico City, Mexico City, Mexico

Countries

Mexico

Other Identifiers

HJM 1449/08.02.13

Identifier Type: -

Identifier Source: org_study_id