Diabetic Macular Edema Severity at Diagnosis

Distribution of Macular Edema Severity Level at the Moment of Diagnosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00886392

Enrollment

118

Registered

2009-04-22

Start date

2006-06-30

Completion date

2008-04-30

Last updated

2009-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Diabetic Retinopathy, Macular Edema

Keywords

Clinically Significant Macular Edema, Diabetic Macular Edema, Optical Coherence Tomography, Diabetic Retinopathy, Severity

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.

Interventions

None listed

Study design

Observational model

ECOLOGIC_OR_COMMUNITY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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)	at the diagnosis moment

Secondary

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	at the diagnosis moment

Countries

Mexico

Outcome results