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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01194310
First received: August 31, 2010
Last updated: July 10, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
Glaucoma Cataract Procedure: phaco Procedure: phaco-ELT Procedure: phaco-Trabectome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Longtime Efficiency of Combined Cataract-Surgery and Excimer-Laser-Trabeculotomy or Trabectome in Glaucoma Surgery

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Enrollment: 245
Actual Study Start Date: January 1, 2009
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194310

Locations
Switzerland
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01194310     History of Changes
Other Study ID Numbers: Phako/ELT/Trabectome-12m
Study First Received: August 31, 2010
Last Updated: July 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
glaucoma
cataract

Additional relevant MeSH terms:
Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on August 16, 2017