Diabetic Macular Edema Severity at Diagnosis

Diabetes Mellitus Clinical Trial

Official title:

Distribution of Macular Edema Severity Level at the Moment of Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886392
• Other study ID #: HJM 1449/08.02.13
• Status: Completed
• Phase: N/A
• First received: April 21, 2009
• Last updated: April 21, 2009
• Start date: June 2006
• Est. completion date: April 2008

Study information

• Verified date: April 2009
• Source: Hospital Juarez de Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks ProtectionUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Edema
• Macular Edema
• Retinal Diseases

Locations

Country	Name	City	State
Mexico	Hospital Juarez de Mexico	Mexico	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Juarez de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes