CataractICCMENCT04161963
Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery
An observational study of Cataract and Glaucoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
Cystoid macular edema (CME) can limit visual acuity after cataract surgery. Little is known whether the incidence is similar between standard ultrasound phacoemulsification cataract surgery (phaco), femtolaser assisted cataract surgery (FLACS), and combined phacoemulsification cataract surgery plus micro invasive… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SD-OCT and OCT-A
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Mar 2019to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who will undergo cataract surgery or combined catarct MIGS glaucoma surgery at the University Hospital Zurich
Who may be able to join
- Patients with a diagnosis of cataract or
- Patients with a diagnosis of cataract and open angle glaucoma
- Signed lnformed Consent
- Patients at the age of 18 or older
Who cannot join
- Loss of follow up, i.e. not available during the post-operation follow-up inteval.
- Previous known of CME, macular pathology (e.g., Diabetes, exudative age-related macular degeneration, status post retinal vein occlusion) or posterior uveitis.
- Patient unable to understand the study due to cognitive or linguistic incapacity.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Ophthalmology
Zurich, Canton of Zurich, 8091
Marc Toeteberg-Harms, MD, FEBO, +41 44 255 - 1111, marc.toeteberg@usz.ch
About this study
Cystoid macular edema (CME) can limit visual acuity after cataract surgery. Little is known whether the incidence is similar between standard ultrasound phacoemulsification cataract surgery (phaco), femtolaser assisted cataract surgery (FLACS), and combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery (phaco+MIGS) procedures.
Read the detailed description
Subclinical cystoid macular edema (CME) can limit visual acuity after cataract surgery. Little is known whether the incidence is similar between standard ultrasound phacoemulsification cataract surgery (phaco), femtolaser assisted cataract surgery (FLACS), and combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery (phaco+MIGS) procedures.
The investigators hypothesize that CME incidence will be in the following order: FLACS < phaco < phaco+MIGS due to the increase of inflammation with the different surgical procedures.
The study is designed as a single centre, prospective study. The study includes patients with a diagnosis of cataract or cataract and glaucoma who will undergo one of the three above mentioned sürgical procedures at the Department of Ophthalmology at the UniversityHospital Zurich (USZ), Zurich, Switzerland. CME will be assessed by optical coherence tomography of the macular with Heidelberg Spectralis SD-OCT of the Macular at: baseline (i.e. preoperative), 1 week, 1 month, 3 months, and 6 months post-surgery. Furthermore, a swept source Optical Coherence Tomography Angiography (OCT-A) using Zeiss Plex Elite 9000 will be performed at: baseline (i.e. preoperative), 1 week, 1 month, and 6 months post-surgery to image the retinal vessels.
- Being tested
- SD-OCT, OCT-A
- Keywords
- Cataract, Glaucoma, cystroid macular edema
- Medical subject headings
- Cataract, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SD-OCTDevice
Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
OCT-ADevice
swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula
| Study group | Role | What they receive |
|---|---|---|
| Phaco | tandard ultrasound phacoemulsification cataract surgery Receives: Device: SD-OCT; Device: OCT-A | |
| FLACS | femtolaser assisted cataract surgery Receives: Device: SD-OCT; Device: OCT-A | |
| phaco+MIGS | combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery Receives: Device: SD-OCT; Device: OCT-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of CME
incidence of subclinical cystoid macular edema
Measured: baseline/preop
incidence of CME
incidence of subclinical cystoid macular edema
Measured: 1 week postop +/- 4 days
incidence of CME
incidence of subclinical cystoid macular edema
Measured: 1 month postop +/-2 weeks
incidence of CME
incidence of subclinical cystoid macular edema
Measured: 3 months postop +/-2 weeks
incidence of CME
incidence of subclinical cystoid macular edema
Measured: 6 months postop +/-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start4 Mar 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Töteberg-Harms, MD, FEBO, Principal investigator, University Hospital Zurich, Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161963
- Sponsor's protocol ID
- ICCME
- Acronym
- ICCME
- Status last verified
- Mar 2020
- First submitted
- 11 Nov 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery
- ClinicalTrials.gov ID
- NCT04161963
- Acronym / sponsor ID
- ICCME / ICCME
- Keywords
- Cataract, Glaucoma, cystroid macular edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Nov 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.
Cystoid macular edema (CME) can limit visual acuity after cataract surgery. Little is known whether the incidence is similar between standard ultrasound phacoemulsification cataract surgery (phaco), femtolaser assisted cataract surgery (FLACS), and combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery (phaco+MIGS) procedures.
Detailed description
Subclinical cystoid macular edema (CME) can limit visual acuity after cataract surgery. Little is known whether the incidence is similar between standard ultrasound phacoemulsification cataract surgery (phaco), femtolaser assisted cataract surgery (FLACS), and combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery (phaco+MIGS) procedures.
The investigators hypothesize that CME incidence will be in the following order: FLACS < phaco < phaco+MIGS due to the increase of inflammation with the different surgical procedures.
The study is designed as a single centre, prospective study. The study includes patients with a diagnosis of cataract or cataract and glaucoma who will undergo one of the three above mentioned sürgical procedures at the Department of Ophthalmology at the UniversityHospital Zurich (USZ), Zurich, Switzerland. CME will be assessed by optical coherence tomography of the macular with Heidelberg Spectralis SD-OCT of the Macular at: baseline (i.e. preoperative), 1 week, 1 month, 3 months, and 6 months post-surgery. Furthermore, a swept source Optical Coherence Tomography Angiography (OCT-A) using Zeiss Plex Elite 9000 will be performed at: baseline (i.e. preoperative), 1 week, 1 month, and 6 months post-surgery to image the retinal vessels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phaco | – | Device: SD-OCT, Device: OCT-Atandard ultrasound phacoemulsification cataract surgery |
| FLACS | – | Device: SD-OCT, Device: OCT-Afemtolaser assisted cataract surgery |
| phaco+MIGS | – | Device: SD-OCT, Device: OCT-Acombined phacoemulsification cataract surgery plus micro invasive glaucoma surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who will undergo cataract surgery or combined catarct MIGS glaucoma surgery at the University Hospital Zurich
Key inclusion criteria (4 listed)
- Patients with a diagnosis of cataract or
- Patients with a diagnosis of cataract and open angle glaucoma
- Signed lnformed Consent
- Patients at the age of 18 or older
Key exclusion criteria (3 listed)
- Loss of follow up, i.e. not available during the post-operation follow-up inteval.
- Previous known of CME, macular pathology (e.g., Diabetes, exudative age-related macular degeneration, status post retinal vein occlusion) or posterior uveitis.
- Patient unable to understand the study due to cognitive or linguistic incapacity.
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 |
|---|---|---|
| SD-OCTOptical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT | Device | FLACS, Phaco, phaco+MIGS |
| OCT-Aswept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula | Device | FLACS, Phaco, phaco+MIGS |
Primary outcome
incidence of CME
Time frame: baseline/preop
incidence of subclinical cystoid macular edema
incidence of CME
Time frame: 1 week postop +/- 4 days
incidence of subclinical cystoid macular edema
incidence of CME
Time frame: 1 month postop +/-2 weeks
incidence of subclinical cystoid macular edema
incidence of CME
Time frame: 3 months postop +/-2 weeks
incidence of subclinical cystoid macular edema
incidence of CME
Time frame: 6 months postop +/-2 weeks
incidence of subclinical cystoid macular edema
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Marc Töteberg-Harms, MD, FEBO principal investigator
University Hospital Zurich, Department of Ophthalmology
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 Cataract and Glaucoma, run by University of Zurich 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Töteberg-Harms, MD, FEBO (+41442558794 ext. +41442558794, marc.toeteberg@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of CME (time frame: baseline/preop). The study lists 5 primary outcomes in all. 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 26 Mar 2020.