ClinicalTrials.gov
ClinicalTrials.gov Menu

Diabetic Macular Edema Severity at Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00886392
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : April 22, 2009
Sponsor:
Information provided by:
Hospital Juarez de Mexico

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.

Condition or disease
Diabetes Mellitus Diabetic Retinopathy Macular Edema

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.


Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Distribution of Macular Edema Severity Level at the Moment of Diagnosis
Study Start Date : June 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Group/Cohort
diabetic macular edema
Type 2 diabetes patients who had clinically significant macular edema by the criterion of the ETDRS



Primary Outcome Measures :
  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) [ Time Frame: at the diagnosis moment ]

Secondary Outcome Measures :
  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 [ Time Frame: at the diagnosis moment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886392


Locations
Mexico
Hospital Juarez de Mexico
Mexico, Distrito Federal, Mexico, 07760
Sponsors and Collaborators
Hospital Juarez de Mexico
Investigators
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: Virgilio Lima Gomez, Hospital Juarez de Mexico
ClinicalTrials.gov Identifier: NCT00886392     History of Changes
Other Study ID Numbers: HJM 1449/08.02.13
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: April 22, 2009
Last Verified: April 2009

Keywords provided by Hospital Juarez de Mexico:
Clinically Significant Macular Edema
Diabetic Macular Edema
Optical Coherence Tomography
Diabetic Retinopathy
Severity

Additional relevant MeSH terms:
Diabetes Mellitus
Edema
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications