Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

Conditions
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Cataract, Glaucoma

Intervention / Treatment
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* Device: SD-OCT
* Device: OCT-A


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phaco<br>tandard ultrasound phacoemulsification cataract surgery | Device: SD-OCT<br>* Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT<br>Device: OCT-A<br>* swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula<br>|
| FLACS<br>femtolaser assisted cataract surgery | Device: SD-OCT<br>* Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT<br>Device: OCT-A<br>* swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula<br>|
| phaco+MIGS<br>combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery | Device: SD-OCT<br>* Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT<br>Device: OCT-A<br>* swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract, Glaucoma, cystroid macular edema