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Clinical Trials/NCT01228799
NCT01228799
Completed
Not Applicable

Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma

University Eye Hospital, Würzburg1 site in 1 country64 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma
Sponsor
University Eye Hospital, Würzburg
Enrollment
64
Locations
1
Primary Endpoint
success rate (complete and qualified success)
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
December 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Eye Hospital, Würzburg

Eligibility Criteria

Inclusion Criteria

  • diagnosed primary or secondary open-angle glaucoma
  • IOP \> 16 mmHg (\<60 days prior surgery)
  • IOP \> 21 mmHg
  • no prior glaucoma surgery (once laser trabeculoplasty or cyclophotocoagulation) allowed

Exclusion Criteria

  • angle closure glaucoma
  • congenital glaucoma
  • combined procedures (glaucoma and cataract)

Outcomes

Primary Outcomes

success rate (complete and qualified success)

Time Frame: 2 years

Success is defined 1. IOP \< 21 mmHg and at least 20% IOP reduction from baseline 2. IOP \< 18 mmHg

Secondary Outcomes

  • IOP, medication, complications(2 years)

Study Sites (1)

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