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Sponsored by: |
Hospital Juarez de Mexico |
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Information provided by: | Hospital Juarez de Mexico |
ClinicalTrials.gov Identifier: | NCT00886392 |
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.
Condition |
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Diabetes Mellitus Diabetic Retinopathy Macular Edema |
Study Type: | Observational |
Study Design: | Ecologic or Community, Prospective |
Official Title: | Distribution of Macular Edema Severity Level at the Moment of Diagnosis |
Enrollment: | 118 |
Study Start Date: | June 2006 |
Study Completion Date: | April 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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diabetic macular edema
Type 2 diabetes patients who had clinically significant macular edema by the criterion of the ETDRS
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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.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
Inclusion Criteria:
Exclusion Criteria:
Mexico, Distrito Federal | |
Hospital Juarez de Mexico | |
Mexico, Distrito Federal, Mexico, 07760 |
Principal Investigator: | Patricia Muñoz Ibarra, MD | Hospital Juarez de Mexico |
Study Director: | Dulce M Razo Blanco Hernandez, MD | Hospital Juarez de Mexico |
Study Chair: | Virgilio Lima Gomez, MD, MsC | Hospital Juarez de Mexico |
Responsible Party: | Hospital Juarez de Mexico ( Virgilio Lima Gomez ) |
Study ID Numbers: | HJM 1449/08.02.13 |
Study First Received: | April 21, 2009 |
Last Updated: | April 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00886392 History of Changes |
Health Authority: | Mexico: Federal Commission for Sanitary Risks Protection; United States: Federal Government |
Clinically Significant Macular Edema Diabetic Macular Edema Optical Coherence Tomography Diabetic Retinopathy Severity |
Metabolic Diseases Eye Diseases Diabetes Mellitus Vascular Diseases Retinal Degeneration Macular Degeneration Edema Endocrine System Diseases Diabetic Angiopathies |
Macular Edema Signs and Symptoms Diabetic Retinopathy Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Retinal Diseases Diabetes Complications |
Metabolic Diseases Eye Diseases Diabetes Mellitus Vascular Diseases Retinal Degeneration Macular Degeneration Edema Endocrine System Diseases |
Diabetic Angiopathies Signs and Symptoms Macular Edema Diabetic Retinopathy Cardiovascular Diseases Glucose Metabolism Disorders Retinal Diseases Diabetes Complications |