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

Diabetic Macular Edema Clinical Trial

— DICAT-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04096131
• Other study ID #: DICAT-II
• Status: Completed
• Start date: January 28, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: August 2021
• Source: European School of Advanced Studies in Ophthalmology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: January 31, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

Inclusion Criteria:

Eligible patients will be identified during the regular preoperative cataract examination. In the presence of a diabetic patient, an OCT scan will be performed (according to the protocol, see below).

Only eyes with E-DME will be eligible for the study.

Inclusion criteria may be one of the following:

1. Diabetic patients with bilateral E-DME and bilateral cataract. Both eyes will be enrolled: one eye will receive surgery at M4, the other at the end of follow up (M8) or later (gold candidate).

2. Diabetic patients with bilateral E-DME and cataract in just one eye (gold candidate). The eye with E-DME and no cataract may be already pseudophakic (surgery performed at least 18 months before) or with clear media.

3. Diabetic patients with E-DME and cataract in just one eye

4. Diabetic patients with cataract and no E-DME in the eye scheduled for surgery but E-DME in the other eye. Only the eye with E-DME will be enrolled.

Exclusion Criteria:

1. Past ocular surgery of any kind (except for cataract surgery) or ocular pathologies other than diabetic retinopathy.

2. Macular edema considered to be due to a cause other than diabetic macular edema.

3. OCT examination suggesting that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema. In the case of ERM, an OCT scan must be sent to the Coordinating Center for approval.

4. Any ocular pathology or ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema

5. History of any therapy (anti-VEGF treatment, focal/grid macular photocoagulation, intravitreous or peribulbar corticosteroids) for DME or diabetic retinopathy in the past 12 months.

6. History of YAG capsulotomy performed within two months before enrollment.

7. Aphakia.

8. Evidence of uncontrolled glaucoma.

9. Intraocular pressure must be <25 mmHg, with no more than one topical glaucoma medication.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• cataract surgery
phacoemulsification

Locations

Country	Name	City	State
Switzerland	ESASO Scientific Projects	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
European School of Advanced Studies in Ophthalmology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of cataract surgery on E-DME	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.	4 months