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

NCT04096131 | Completed DMC

• 1 other identifier: DICAT-II
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Macular Edema; Cataract Senile; Surgery--Complications

Keywords

diabetic macular edema; cataract; surgery

Outcome Measures

Primary Outcomes (1)

• 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of at least 50 microns in central subfield thickness (CST) or 0.5 mm3 in macular volume (MV) measured by SD-OCT will be withdrawn from the study to receive adequate therapeutic intervention.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

Study Arms (2)

SURGERY

subjects with early DME undergoing cataract surgery

Procedure: cataract surgery

OBSERVATION

subjects with early DME

Interventions

cataract surgery PROCEDURE

phacoemulsification

SURGERY

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study Groups GROUP 1: Eyes with E-DME scheduled for cataract surgery GROUP 2: Control Group. Eyes with E-DME and clear media, non-significant cataract, pseudophakic (Group 2a: phakic; Group 2b: pseudophakic) or eyes with cataract scheduled for surgery after the end of follow up. Gold candidate: patient with bilateral E-DME and cataract in at least one eye.

You may qualify if:

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

You may not qualify if:

• Past ocular surgery of any kind (except for cataract surgery) or ocular pathologies other than diabetic retinopathy.
• Macular edema considered to be due to a cause other than diabetic macular edema.
• 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.
• Any ocular pathology or ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema
• 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.
• History of YAG capsulotomy performed within two months before enrollment.
• Aphakia.
• Evidence of uncontrolled glaucoma.
• Intraocular pressure must be \<25 mmHg, with no more than one topical glaucoma medication.

Sponsors & Collaborators

• European School of Advanced Studies in Ophthalmology: lead

Study Sites (1)

ESASO Scientific Projects

Lugano, CH-6901, Switzerland

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Studies Coordinator

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 19, 2019
• Study Start: January 28, 2020
• Primary Completion: November 30, 2020
• Study Completion: January 31, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)