Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery (ICCME)

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.

Study Overview

• Status: Unknown
• Conditions: Glaucoma; Cataract
• Intervention / Treatment: Device: SD-OCT; Device: OCT-A

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • Recruiting
      • Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient who will undergo cataract surgery or combined catarct MIGS glaucoma surgery at the University Hospital Zurich

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phaco; tandard ultrasound phacoemulsification cataract surgery	Device: SD-OCT; Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT; Device: OCT-A; swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula
FLACS; femtolaser assisted cataract surgery	Device: SD-OCT; Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT; Device: 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	Device: SD-OCT; Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT; Device: OCT-A; swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of CME	incidence of subclinical cystoid macular edema	baseline/preop
incidence of CME	incidence of subclinical cystoid macular edema	1 week postop +/- 4 days
incidence of CME	incidence of subclinical cystoid macular edema	1 month postop +/-2 weeks
incidence of CME	incidence of subclinical cystoid macular edema	3 months postop +/-2 weeks
incidence of CME	incidence of subclinical cystoid macular edema	6 months postop +/-2 weeks

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Marc Töteberg-Harms, MD, FEBO, University Hospital Zurich, Department of Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Cataract; Glaucoma; cystroid macular edema
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Lens Diseases; Glaucoma; Macular Edema; Cataract; Capsule Opacification
• Other Study ID Numbers: ICCME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No