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Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04161963
Acronym
ICCME
Enrollment
150
Registered
2019-11-13
Start date
2019-03-04
Completion date
2021-12-31
Last updated
2020-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Glaucoma

Keywords

Cataract, Glaucoma, cystroid macular edema

Brief 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 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.

Interventions

DEVICESD-OCT

Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT

DEVICEOCT-A

swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
incidence of CMEbaseline/preopincidence of subclinical cystoid macular edema

Countries

Switzerland

Contacts

Primary ContactMarc Töteberg-Harms, MD, FEBO
marc.toeteberg@usz.ch+41442558794

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026