Diabetic Macular Edema Severity at Diagnosis

NCT00886392 | Completed

• 1 other identifier: HJM 1449/08.02.13
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Diabetic Retinopathy; Macular Edema

Keywords

Clinically Significant Macular Edema; Diabetic Macular Edema; Optical Coherence Tomography; Diabetic Retinopathy; Severity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

diabetic macular edema

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

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Target population were type 2 diabetic patients with CSME who attended general hospitals of Mexico City and its metropolitan area; available population were patients with CSME evaluated at a general hospital

You may qualify if:

• type 2 diabetic
• regardless of diabetes duration and retinopathy severity level
• one or both eyes with CSME

You may not qualify if:

• media opacities that prevented an adequate fast macular map from being acquired
• a thickened posterior vitreous
• any additional retinal disease

Sponsors & Collaborators

• Hospital Juarez de Mexico: lead

Study Sites (1)

Hospital Juarez de Mexico

Mexico City, Mexico City, 07760, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy; Macular Edema

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Macular Degeneration; Retinal Degeneration

Study Officials

• Patricia Muñoz Ibarra, MD

  Hospital Juarez de Mexico

  PRINCIPAL INVESTIGATOR

• Dulce M Razo Blanco Hernandez, MD

  Hospital Juarez de Mexico

  STUDY DIRECTOR

• Virgilio Lima Gomez, MD, MsC

  Hospital Juarez de Mexico

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 21, 2009
• First Posted: April 22, 2009
• Study Start: June 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: April 1, 2008
• Last Updated: April 22, 2009

Record last verified: 2009-04

Locations

ME (1)