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Trabeculectomy Versus Canaloplasty (TVC)

Primary Purpose

Glaucoma, Canaloplasty, Trabeculectomy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
trabeculectomy
Canaloplasty
Sponsored by
University Eye Hospital, Würzburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring trabeculectomy,, canaloplasty,, glaucoma surgery, non-penetrating surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Trabeculectomy

Canaloplasty

Arm Description

Trabeculectomy with Mitomycin C

Canaloplasty with implant of suture

Outcomes

Primary Outcome Measures

success rate (complete and qualified success)
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)
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
intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively
IOP, medication, complications
intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively

Full Information

First Posted
October 20, 2010
Last Updated
August 16, 2013
Sponsor
University Eye Hospital, Würzburg
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1. Study Identification

Unique Protocol Identification Number
NCT01228799
Brief Title
Trabeculectomy Versus Canaloplasty
Acronym
TVC
Official Title
Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Eye Hospital, Würzburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Canaloplasty, Trabeculectomy
Keywords
trabeculectomy,, canaloplasty,, glaucoma surgery, non-penetrating surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trabeculectomy
Arm Type
Active Comparator
Arm Description
Trabeculectomy with Mitomycin C
Arm Title
Canaloplasty
Arm Type
Active Comparator
Arm Description
Canaloplasty with implant of suture
Intervention Type
Procedure
Intervention Name(s)
trabeculectomy
Intervention Description
trabeculectomy with mitomycin C 0.2mg/ml
Intervention Type
Procedure
Intervention Name(s)
Canaloplasty
Intervention Description
Canaloplasty with implant of suture
Primary Outcome Measure Information:
Title
success rate (complete and qualified success)
Description
Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg
Time Frame
1 year
Title
success rate (complete and qualified success)
Description
Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg
Time Frame
2 years
Secondary Outcome Measure Information:
Title
IOP, medication, complications
Description
intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively
Time Frame
1 year
Title
IOP, medication, complications
Description
intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: angle closure glaucoma congenital glaucoma combined procedures (glaucoma and cataract)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Klink, MD
Organizational Affiliation
University Eye Hospital, Würzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Eye Hospital
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

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Trabeculectomy Versus Canaloplasty

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