Clinical trial NCT04161963: Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery
Official title: Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract
Glaucoma
Keywords: Cataract
Glaucoma
cystroid macular edema
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who will undergo cataract surgery or combined catarct MIGS glaucoma surgery at the University Hospital Zurich

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.

Eligibility criteria: 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.

Primary outcomes:
measure: incidence of CME
timeFrame: baseline/preop
measure: incidence of CME
timeFrame: 1 week postop +/- 4 days
measure: incidence of CME
timeFrame: 1 month postop +/-2 weeks
measure: incidence of CME
timeFrame: 3 months postop +/-2 weeks
measure: incidence of CME
timeFrame: 6 months postop +/-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Ophthalmology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Department of Ophthalmology
name: Marc Töteberg-Harms, MD, FEBO
role: PRINCIPAL_INVESTIGATOR
References: