---
title: Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery
nct_id: NCT04161963
overall_status: UNKNOWN
sponsor: University of Zurich
study_type: OBSERVATIONAL
primary_condition: Cataract
countries: Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04161963.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04161963"
ct_last_update_post_date: 2020-03-26
last_seen_at: "2026-05-12T06:38:28.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

**NCT ID:** [NCT04161963](https://clinicaltrials.gov/study/NCT04161963)

## Key Facts

- **Status:** UNKNOWN
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 150
- **Lead Sponsor:** University of Zurich
- **Conditions:** Cataract, Glaucoma
- **Start Date:** 2019-03-04
- **Completion Date:** 2021-12-31
- **CT.gov Last Update:** 2020-03-26

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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.
```

## Arms

- **Phaco** — tandard ultrasound phacoemulsification cataract surgery
- **FLACS** — femtolaser assisted cataract surgery
- **phaco+MIGS** — combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery

## Interventions

- **SD-OCT** (DEVICE) — Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
- **OCT-A** (DEVICE) — swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula

## Primary Outcomes

- **incidence of CME** _(time frame: baseline/preop)_ — incidence of subclinical cystoid macular edema
- **incidence of CME** _(time frame: 1 week postop +/- 4 days)_ — incidence of subclinical cystoid macular edema
- **incidence of CME** _(time frame: 1 month postop +/-2 weeks)_ — incidence of subclinical cystoid macular edema
- **incidence of CME** _(time frame: 3 months postop +/-2 weeks)_ — incidence of subclinical cystoid macular edema
- **incidence of CME** _(time frame: 6 months postop +/-2 weeks)_ — incidence of subclinical cystoid macular edema

## Locations (1)

- Department of Ophthalmology, Zurich, Canton of Zurich, Switzerland — _RECRUITING_

## Recent Field Changes (last 30 days)

- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of ophthalmology|zurich|canton of zurich|switzerland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04161963.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04161963*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*