Trabeculectomy Versus Canaloplasty (TVC)

This study has been completed.
Sponsor:
Information provided by:
University Eye Hospital, Würzburg
ClinicalTrials.gov Identifier:
NCT01228799
First received: October 20, 2010
Last updated: August 16, 2013
Last verified: October 2010

October 20, 2010
August 16, 2013
June 2010
December 2012   (final data collection date for primary outcome measure)
  • success rate (complete and qualified success) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg
  • success rate (complete and qualified success) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg
Same as current
Complete list of historical versions of study NCT01228799 on ClinicalTrials.gov Archive Site
  • IOP, medication, complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively
  • IOP, medication, complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively
Same as current
Not Provided
Not Provided
 
Trabeculectomy Versus Canaloplasty
Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma

Study aims for comparison of trabeculectomy and canaloplasty, in order to find out if one operation is superior to the other. Both procedures are performed in patients with medically uncontrolled open-angle glaucoma. Canaloplasty is a recently newly introduced procedure, which showed encouraging results without antimetabolite usage intra- and postoperatively. Purpose of the study is to compare both surgeries concerning success rate, intraocular pressure, medication and complications. So far there is no comparison of the standard procedure trabeculectomy and the new approach, canaloplasty available.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Glaucoma
  • Canaloplasty
  • Trabeculectomy
  • Procedure: trabeculectomy
    trabeculectomy with mitomycin C 0.2mg/ml
  • Procedure: Canaloplasty
    Canaloplasty with implant of suture
  • Active Comparator: Trabeculectomy
    Trabeculectomy with Mitomycin C
    Intervention: Procedure: trabeculectomy
  • Active Comparator: Canaloplasty
    Canaloplasty with implant of suture
    Intervention: Procedure: Canaloplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:1. diagnosed primary or secondary open-angle glaucoma 2. IOP > 16 mmHg (<60 days prior surgery) 3. IOP > 21 mmHg 4. no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed

Exclusion Criteria:

  1. angle closure glaucoma
  2. congenital glaucoma
  3. combined procedures (glaucoma and cataract)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01228799
TVC-1, TVC
No
University Eye Hospital, University Hospitals Würzburg
University Eye Hospital, Würzburg
Not Provided
Principal Investigator: Thomas Klink, MD University Eye Hospital, Würzburg
University Eye Hospital, Würzburg
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP