Clinical trial NCT00886392: Diabetic Macular Edema Severity at Diagnosis
Official title: Distribution of Macular Edema Severity Level at the Moment of Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Diabetic Retinopathy
Macular Edema
Keywords: Clinically Significant Macular Edema
Diabetic Macular Edema
Optical Coherence Tomography
Diabetic Retinopathy
Severity
Lead sponsor: Hospital Juarez de Mexico
Sponsor class: OTHER_GOV
First posted: 2009-04-22
Enrollment: 118
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: 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)
timeFrame: at the diagnosis moment
Secondary outcomes:
measure: 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
timeFrame: at the diagnosis moment
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Hospital Juarez de Mexico
state: Distrito Federal
Study officials:
affiliation: Hospital Juarez de Mexico
name: Patricia Muñoz Ibarra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Juarez de Mexico
name: Dulce M Razo Blanco Hernandez, MD
role: STUDY_DIRECTOR
affiliation: Hospital Juarez de Mexico
name: Virgilio Lima Gomez, MD, MsC
role: STUDY_CHAIR
References: