Trabeculectomy Versus Canaloplasty (TVC)

August 16, 2013 updated by: University Eye Hospital, Würzburg

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Würzburg, Bavaria, Germany, 97080
        • University Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success rate (complete and qualified success)
Time Frame: 1 year
Success is defined 1. IOP < 21 mmHg and at least 20% IOP reduction from baseline 2. IOP < 18 mmHg
1 year
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP, medication, complications
Time Frame: 1 year
intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively
1 year
IOP, medication, complications
Time Frame: 2 years
intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Eye Hospital, Würzburg

Investigators

  • Principal Investigator: Thomas Klink, MD, University Eye Hospital, Würzburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 26, 2010

First Posted (ESTIMATE)

October 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVC-1
  • TVC (OTHER: University Eye Hospital Wurzburg)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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