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

NCT ID: NCT04096131

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 143 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-28
• Study Completion Date: 2021-01-31

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

SURGERY

subjects with early DME undergoing cataract surgery

cataract surgery

Intervention Type: PROCEDURE

phacoemulsification

OBSERVATION

subjects with early DME

No interventions assigned to this group

Interventions

cataract surgery

phacoemulsification

Intervention Type: PROCEDURE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European School of Advanced Studies in Ophthalmology

OTHER

Sponsor Role: lead

Responsible Party

Giacomo Panozzo

Scientific Studies Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ESASO Scientific Projects

Lugano, , Switzerland

Countries

Switzerland

Other Identifiers

DICAT-II

Identifier Type: -

Identifier Source: org_study_id