Influence of Cataract Surgery on Early DME The DICAT-II Study (DICAT-II)
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|ClinicalTrials.gov Identifier: NCT04096131|
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment|
|Diabetic Macular Edema Cataract Senile Surgery--Complications||Procedure: cataract surgery|
Cataract surgery worsens preoperative DME, deserving an adequate pre and postoperative treatment. A large British study demonstrated that even eyes without preexisting edema are at risk of DME development after surgery according to the gravity of retinopathy. A new DME classification (the ESASO Classification of DME) defines a new category of DME, named early DME (E-DME) as follow: presence of small intraretinal cysts associated with well-recognizable and detectable inner retinal layers, ellipsoid zone (EZ) and external limiting membrane (ELM), with increase in central subfield thickness (CST) and/or macular volume (MV) less than 30% of maximum normal values.
Due to its undetectable or minimal impact on visual function, E-DME has not yet been studied, and retinologists usually restrict treatment to more advanced cases.
E-DME is the most frequent type of DME among the population undergoing cataract surgery, estimated by DICAT-I Study in 20.7% of the diabetic subjects, corresponding to 5.4% of the general population.
It has been demonstrated that cataract surgery has a negative impact both on diabetic eyes with no DME and in eyes with advanced DME. Even E-DME therefore probably worsens after surgery but there are no data on this matter.
Study Objective: to determine if cataract surgery may have an impact on the natural history of early DME (E-DME) Study Design: prospective multi-center observational case-control study
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Influence of Cataract Surgery on Early DME: the DICAT-II Study|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||November 1, 2020|
subjects with early DME undergoing cataract surgery
Procedure: cataract surgery
subjects with early DME
- Influence of cataract surgery on E-DME [ Time Frame: 4 months ]
Changes in central subfield thickness (CST) and/or macular volume (MV) measured by SD-OCT in eyes with E-DME during the first 4 months after cataract surgery (Group 1) compared to eyes with the same condition but without any surgical intervention (Group 2).
Eyes in both groups developing a "significant worsening" of E-DME, defined as an increase of at least 50 microns in central subfield thickness (CST) or 0.5 mm3 in macular volume (MV) measured by SD-OCT will be withdrawn from the study to receive adequate therapeutic intervention.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096131
|ESASO Scientific Projects|
|Lugano, Switzerland, CH-6901|
|Contact: Giacomo A Panozzo, MD +393483365239 email@example.com|