Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Diabetic Macular Edema Severity at Diagnosis

This study has been completed.
Sponsor:
Information provided by:
Hospital Juarez de Mexico
ClinicalTrials.gov Identifier:
NCT00886392
First received: April 21, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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
Diabetes Mellitus
Diabetic Retinopathy
Macular Edema

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Distribution of Macular Edema Severity Level at the Moment of Diagnosis

Resource links provided by NLM:


Further study details as provided by Hospital Juarez de Mexico:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: April 21, 2009
Last Updated: April 21, 2009
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection
United States: Federal Government

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
Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Glucose Metabolism Disorders
Macular Degeneration
Metabolic Diseases
Retinal Degeneration
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014