ESASO Scientific Projects
Lugano, CH-6901, Switzerland
NCT Number: NCT05080803
Retrospective multi-center observational study on functional and morphological outcome of initial therapy for DME according to ESASO Morphologic Classification.
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Notify Me50 year and older
All sexes
Observational
Lugano, CH-6901, Switzerland
The ESASO morphologic classification of diabetic macular edema defines four stages of progression of the disease: early, advanced, chronic and atrophic maculopathy.
This grading is generated by the analysis of seven biomarkers that fully describe the level of retinal damage. Aim of this classification is to be a valid method for a comprehensive description of DME in scientific studies or clinical practice.
Given the recent publication of ESASO Classification, there aren't observations on the real relevance of grading DME on therapeutic outcome.
This retrospective study wants to give a preliminary answer to this important issue.
As a corollary outcome, this study will also evaluate the concordance of grading among participants.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
. Eligible eyes at the retrospective review
Exclusion criteria
intravitreal administration
Time frame: Four months
Visual acuity and morphological (OCT) stage of the disease (as described in ESASO DME classification) will be evaluated at time 0 and four months after the first injection of intravitreal dexamethasone or one month after the loading phase (3 monthly injections) with anti-VEGF.
Time frame: 3 months
After preliminary instruction on ESASO Staging system of DME, participating centers will evaluate the stage of DME at time 0 of every eye retrospectically selected to participate to the study. This staging will be than validated by the Coordinating Center, and the total concordance of staging (K index) will be used to validate the Classification
European School of Advanced Studies in Ophthalmology
Other
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