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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
Sponsor:
Information provided by (Responsible Party):
Giacomo Panozzo, European School of Advanced Studies in Ophthalmology

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

Condition or disease Intervention/treatment
Diabetic Macular Edema Cataract Senile Surgery--Complications Procedure: cataract surgery

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
SURGERY
subjects with early DME undergoing cataract surgery
Procedure: cataract surgery
phacoemulsification

OBSERVATION
subjects with early DME



Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096131


Locations
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Switzerland
ESASO Scientific Projects
Lugano, Switzerland, CH-6901
Contact: Giacomo A Panozzo, MD    +393483365239    g.panozzo@iol.it   
Sponsors and Collaborators
European School of Advanced Studies in Ophthalmology
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Responsible Party: Giacomo Panozzo, Scientific Studies Coordinator, European School of Advanced Studies in Ophthalmology
ClinicalTrials.gov Identifier: NCT04096131    
Other Study ID Numbers: DICAT-II
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giacomo Panozzo, European School of Advanced Studies in Ophthalmology:
diabetic macular edema
cataract
surgery
Additional relevant MeSH terms:
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Cataract
Macular Edema
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases