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
  Purpose

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.


Condition Intervention
Glaucoma
Canaloplasty
Trabeculectomy
Procedure: trabeculectomy
Procedure: Canaloplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma

Resource links provided by NLM:


Further study details as provided by University Eye Hospital, Würzburg:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 64
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Trabeculectomy
Trabeculectomy with Mitomycin C
Procedure: trabeculectomy
trabeculectomy with mitomycin C 0.2mg/ml
Active Comparator: Canaloplasty
Canaloplasty with implant of suture
Procedure: Canaloplasty
Canaloplasty with implant of suture

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT01228799

Locations
Germany
University Eye Hospital
Würzburg, Bavaria, Germany, 97080
Sponsors and Collaborators
University Eye Hospital, Würzburg
Investigators
Principal Investigator: Thomas Klink, MD University Eye Hospital, Würzburg
  More Information

No publications provided

Responsible Party: University Eye Hospital, University Hospitals Würzburg
ClinicalTrials.gov Identifier: NCT01228799     History of Changes
Other Study ID Numbers: TVC-1, TVC
Study First Received: October 20, 2010
Last Updated: August 16, 2013
Health Authority: Germany: No

Keywords provided by University Eye Hospital, Würzburg:
trabeculectomy,
canaloplasty,
glaucoma surgery
non-penetrating surgery

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on October 23, 2014