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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01194310
First Posted: September 2, 2010
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Zurich
August 31, 2010
September 2, 2010
July 13, 2017
January 1, 2009
December 31, 2016   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01194310 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phaco vs. Phaco-ELT vs. Phaco-Trabectome 12m
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.

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
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample
primary care clinic
  • Glaucoma
  • Cataract
  • 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)
  • Procedure: phaco-Trabectome
    Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus Trabectome
  • phaco alone
    patients w/ diagnosis of open angle glaucoma underwent phaco alone
    Intervention: Procedure: phaco
  • phaco-ELT
    patients w/ diagnosis of open angle glaucoma underwent combined phaco plus ELT
    Interventions:
    • Procedure: phaco
    • Procedure: phaco-ELT
  • phaco-Trabectome
    patients w/ diagnosis of open angle glaucoma underwent combined phaco plus Trabectome
    Interventions:
    • Procedure: phaco
    • Procedure: phaco-Trabectome
Töteberg-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
245
December 31, 2016
December 31, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT01194310
Phako/ELT/Trabectome-12m
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
University of Zurich
University of Zurich
Not Provided
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
July 2017