TVC: Trabeculectomy Versus Canaloplasty

• Sponsor: University Eye Hospital, Würzburg (Other)
• Overall Status: Completed
• CT.gov ID: NCT01228799
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma; Canaloplasty; Trabeculectomy	Procedure: trabeculectomy; Procedure: Canaloplasty	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Longterm Comparison Between Trabeculectomy and Canaloplasty in Open-angle Glaucoma
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. success rate (complete and qualified success) [1 year]

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

2. success rate (complete and qualified success) [2 years]

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

Secondary Outcome Measures

1. IOP, medication, complications [1 year]

   intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively

2. IOP, medication, complications [2 years]

   intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Eye Hospital	Würzburg	Bavaria	Germany	97080

Sponsors and Collaborators

• University Eye Hospital, Würzburg

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01228799
• Other Study ID Numbers: TVC-1; TVC
• First Posted: Oct 27, 2010
• Last Update Posted: Aug 19, 2013
• Last Verified: Oct 1, 2010

• Keywords provided by , ,: trabeculectomy,; canaloplasty,; glaucoma surgery; non-penetrating surgery
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Aug 19, 2013