Phaco vs. Phaco-ELT vs. Phaco-Trabectome 12m

July 10, 2017 updated by: University of Zurich

Longtime Efficiency of Combined Cataract-Surgery and Excimer-Laser-Trabeculotomy or Trabectome in Glaucoma Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Glaucoma is one of the most common reasons for blindness. Usually an elevated drain resistance is the reason, while aqueous humor production is normal. Medical reduction of intraocular pressure (IOP) is first line therapy in most cases. The gold standard of surgical treatment still is trabeculectomy (TE) but TE has a lot of drawbacks. In particular when glaucoma and cataract coexists, the investigators therefore prefer the combined procedure cataract extraction plus excimer laser trabeculotomy (ELT) or plus Trabectome. Indication is cataract and a moderate elevated IOP without medical therapy or a moderate cataract and elevated IOP with medical therapy.

The ELT is performed by an AIDA XeCl-Excimer Laser System (TUI-Laser AG, Germering, 1,2 mJ per burst, burst duration 16 ns, wave length 308 nm, spot diameter 200 µm). 10 foramina were made over 90 degrees of the anterior chamber angle. Trabectome procedure is performed with the Trabectome unit from Neomedix.

  • Trial with medical device
  • Trial with surgical intervention

Study Type

Observational

Enrollment (Actual)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion criteria:

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

Exclusion criteria:

  • IOP >35 mmHg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
phaco alone
patients w/ diagnosis of open angle glaucoma underwent phaco alone
Procedure: phaco
Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone
phaco-ELT
patients w/ diagnosis of open angle glaucoma underwent combined phaco plus ELT
Procedure: phaco
Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone
Procedure: phaco-ELT
Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus excimer laser trabeculotomy (ELT)
phaco-Trabectome
patients w/ diagnosis of open angle glaucoma underwent combined phaco plus Trabectome
Procedure: phaco
Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone
Procedure: phaco-Trabectome
Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus Trabectome

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

August 31, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (Estimate)

September 2, 2010

Study Record Updates

Last Update Posted (Actual)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 10, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Phako/ELT/Trabectome-12m

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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