Trabeculectomy Versus Canaloplasty

Glaucoma Clinical Trial

— TVC  

Official title:

Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228799
• Other study ID #: TVC-1
• Secondary ID: TVC
• Status: Completed
• Phase: N/A
• First received: October 20, 2010
• Last updated: August 16, 2013
• Start date: June 2010
• Est. completion date: December 2012

Study information

• Verified date: October 2010
• Source: University Eye Hospital, Würzburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Canaloplasty
• Glaucoma
• Trabeculectomy

Intervention

Procedure:
• trabeculectomy
trabeculectomy with mitomycin C 0.2mg/ml
• Canaloplasty
Canaloplasty with implant of suture

Locations

Country	Name	City	State
Germany	University Eye Hospital	Würzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Eye Hospital, Würzburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year	No
Primary	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	2 years	No
Secondary	IOP, medication, complications	intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively	1 year	Yes
Secondary	IOP, medication, complications	intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively	2 years	Yes