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Status unknownNCT04161963ICCMEUpdated Mar 26, 2020

Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

An observational study in Cataract and Glaucoma, sponsored by University of Zurich. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-26.

Sponsored by University of Zurich · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cataract
  • Glaucoma

Keywords

  • Cataract
  • Glaucoma
  • cystroid macular edema
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Phaco

    tandard ultrasound phacoemulsification cataract surgery

    Device: SD-OCT · Device: OCT-A

  • FLACS

    femtolaser assisted cataract surgery

    Device: SD-OCT · Device: OCT-A

  • phaco+MIGS

    combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery

    Device: SD-OCT · Device: OCT-A

Interventions

  • DeviceSD-OCT

    Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT

  • DeviceOCT-A

    swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula

05

What researchers measure

Primary outcomes

  1. incidence of CME

    incidence of subclinical cystoid macular edema

    Time frame: baseline/preop

  2. incidence of CME

    incidence of subclinical cystoid macular edema

    Time frame: 1 week postop +/- 4 days

  3. incidence of CME

    incidence of subclinical cystoid macular edema

    Time frame: 1 month postop +/-2 weeks

  4. incidence of CME

    incidence of subclinical cystoid macular edema

    Time frame: 3 months postop +/-2 weeks

  5. incidence of CME

    incidence of subclinical cystoid macular edema

    Time frame: 6 months postop +/-2 weeks

06

Study locations

1 of 1 sites recruiting
  • Department of Ophthalmology
    Zurich, ZH 8091, Switzerland
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04161963
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Nov 13, 2019
Start date
Mar 4, 2019
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Mar 26, 2020

Study contacts

Marc Töteberg-Harms, MD, FEBO
Contact
marc.toeteberg@usz.ch
+41442558794 ext. +41442558794
Marc Töteberg-Harms, MD, FEBO
principal investigator · University Hospital Zurich, Department of Ophthalmology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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