NCT01194310

Brief Summary

This study compares efficacy (i.e. IOP and hypotensive medications) of phaco alone vs. combined phaco plus excimer laser trabeculotomy vs. combined phaco plus trabectome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

8 years

First QC Date

August 31, 2010

Last Update Submit

July 10, 2017

Conditions

GlaucomaCataract

Keywords

glaucomacataract

Study Arms (3)

phaco alone

patients w/ diagnosis of open angle glaucoma underwent phaco alone

Procedure: phaco

phaco-ELT

patients w/ diagnosis of open angle glaucoma underwent combined phaco plus ELT

Procedure: phacoProcedure: phaco-ELT

phaco-Trabectome

patients w/ diagnosis of open angle glaucoma underwent combined phaco plus Trabectome

Procedure: phacoProcedure: phaco-Trabectome

Interventions

phacoPROCEDURE

Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone

phaco alonephaco-ELTphaco-Trabectome
phaco-ELTPROCEDURE

Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus excimer laser trabeculotomy (ELT)

phaco-ELT
phaco-TrabectomePROCEDURE

Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus Trabectome

phaco-Trabectome

Eligibility Criteria

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

primary care clinic

You may qualify if:

  • All patients, which had Phaco, Phako/ELT, or Phaco-Trabectome from 01/2008 until 12/2011, where screened 12 month after surgery

You may not qualify if:

  • IOP \>35 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zurich, Switzerland

Location

Related Publications (1)

  • Toteberg-Harms M, Hanson JV, Funk J. Cataract surgery combined with excimer laser trabeculotomy to lower intraocular pressure: effectiveness dependent on preoperative IOP. BMC Ophthalmol. 2013 Jun 24;13:24. doi: 10.1186/1471-2415-13-24.

    PMID: 23799932DERIVED

MeSH Terms

Conditions

GlaucomaCataract

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2010

First Posted

September 2, 2010

Study Start

January 1, 2009

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

July 13, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)