- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00886392
Diabetic Macular Edema Severity at Diagnosis
Distribution of Macular Edema Severity Level at the Moment of Diagnosis
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Distrito Federal
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Mexico, Distrito Federal, Mexico, 07760
- Hospital Juarez de Mexico
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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at the diagnosis moment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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at the diagnosis moment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Virgilio Lima Gomez, MD, MsC, Hospital Juarez de Mexico
- Study Director: Dulce M Razo Blanco Hernandez, MD, Hospital Juarez de Mexico
- Principal Investigator: Patricia Muñoz Ibarra, MD, Hospital Juarez de Mexico
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HJM 1449/08.02.13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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