Diabetic Macular EdemaDICAT-IINCT04096131
Influence of Cataract Surgery on Early DME The DICAT-II Study
An observational study of Diabetic Macular Edema and Cataract Senile, run by European School of Advanced Studies in Ophthalmology at 1 site in Switzerland.
Trial summary
To determine if cataract surgery may have an impact on the natural history of early DME (E-DME) Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Diabetic Macular Edema, Cataract Senile, Surgery--Complications
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 143 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Jan 2020to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Aphakia.
- Evidence of uncontrolled glaucoma.
- Intraocular pressure must be <25 mmHg, with no more than one topical glaucoma medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Cataract Surgery on Early DME: the DICAT-II Study
To determine if cataract surgery may have an impact on the natural history of early DME (E-DME)
Read the 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
- Being tested
- cataract surgery
- Keywords
- diabetic macular edema, cataract, surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryProcedure or surgery
phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| SURGERY | subjects with early DME undergoing cataract surgery Receives: Procedure: cataract surgery | |
| OBSERVATION | subjects with early DME |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start28 Jan 2020
- Primary completion30 Nov 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- European School of Advanced Studies in Ophthalmology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Panozzo, European School of Advanced Studies in Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096131
- Sponsor's protocol ID
- DICAT-II
- Acronym
- DICAT-II
- Status last verified
- Aug 2021
- First submitted
- 9 Sep 2019
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Cataract Surgery on Early DME: the DICAT-II Study
- ClinicalTrials.gov ID
- NCT04096131
- Acronym / sponsor ID
- DICAT-II / DICAT-II
- Keywords
- diabetic macular edema, cataract, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- European School of Advanced Studies in OphthalmologyUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SURGERY | – | Procedure: cataract surgerysubjects with early DME undergoing cataract surgery |
| OBSERVATION | – | –subjects with early DME |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cataract surgeryphacoemulsification | Procedure or surgery | SURGERY |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema and Cataract Senile, run by European School of Advanced Studies in Ophthalmology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of cataract surgery on E-DME (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.