NCT04096131

Influence of Cataract Surgery on Early DME The DICAT-II Study

Influence of Cataract Surgery on Early DME: the DICAT-II Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 143 (actual)
• Sponsor: European School of Advanced Studies in Ophthalmology · Academic / Other
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To determine if cataract surgery may have an impact on the natural history of early DME (E-DME)

Detailed description

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

Conditions

• Diabetic Macular Edema
• Cataract Senile
• Surgery--Complications

Interventions

Type	Name	Description
PROCEDURE	cataract surgery	phacoemulsification

Timeline

• Start date: 2020-01-28
• Primary completion: 2020-11-30
• Completion: 2021-01-31
• First posted: 2019-09-19
• Last updated: 2021-08-16

Locations

1 site across 1 country: Switzerland