Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

• Conditions: Glaucoma; Cataract
• Interventions: Device: SD-OCT; Device: OCT-A

• Registration Number: NCT04161963
• Lead Sponsor: University of 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.

Study Timeline

• Study Start: 2019-03-04
• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-11
• Study First Posted: 2019-11-13
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phaco	OCT-A	tandard ultrasound phacoemulsification cataract surgery
FLACS	SD-OCT	femtolaser assisted cataract surgery
Phaco	SD-OCT	tandard ultrasound phacoemulsification cataract surgery
FLACS	OCT-A	femtolaser assisted cataract surgery
phaco+MIGS	OCT-A	combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery
phaco+MIGS	SD-OCT	combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery

Primary Outcome Measures

Name	Time	Method
incidence of CME	6 months postop +/-2 weeks	incidence of subclinical cystoid macular edema

Trial Locations

Locations (1)

Department of Ophthalmology; 🇨🇭 Zurich, ZH, Switzerland