NCT04161963

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

November 11, 2019

Last Update Submit

March 24, 2020

Conditions

CataractGlaucoma

Keywords

CataractGlaucomacystroid macular edema

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (3)

Phaco

tandard ultrasound phacoemulsification cataract surgery

Device: SD-OCTDevice: OCT-A

FLACS

femtolaser assisted cataract surgery

Device: SD-OCTDevice: OCT-A

phaco+MIGS

combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery

Device: SD-OCTDevice: OCT-A

Interventions

SD-OCTDEVICE

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

FLACSPhacophaco+MIGS
OCT-ADEVICE

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

FLACSPhacophaco+MIGS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

CataractGlaucoma

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesOcular Hypertension

Study Officials

  • Marc Töteberg-Harms, MD, FEBO

    University Hospital Zurich, Department of Ophthalmology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Töteberg-Harms, MD, FEBO

CONTACT

+41442558794marc.toeteberg@usz.ch

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 13, 2019

Study Start

March 4, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)