Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery
NCT ID: NCT04161963
Last Updated: 2020-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2019-03-04
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Phaco
tandard ultrasound phacoemulsification cataract surgery
SD-OCT
Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
OCT-A
swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula
FLACS
femtolaser assisted cataract surgery
SD-OCT
Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
OCT-A
swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula
phaco+MIGS
combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery
SD-OCT
Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
OCT-A
swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula
Interventions
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SD-OCT
Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
OCT-A
swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula
Eligibility Criteria
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Inclusion Criteria
* Patients with a diagnosis of cataract and open angle glaucoma
* Signed lnformed Consent
* Patients at the age of 18 or older
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Marc Töteberg-Harms, MD, FEBO
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich, Department of Ophthalmology
Locations
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Department of Ophthalmology
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ICCME
Identifier Type: -
Identifier Source: org_study_id
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