Trabeculectomy Versus Canaloplasty

Not Applicable

Completed

• Conditions: Glaucoma; Canaloplasty; Trabeculectomy
• Interventions: Procedure: trabeculectomy; Procedure: Canaloplasty

• Registration Number: NCT01228799
• Lead Sponsor: University Eye Hospital, Würzburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Status Verified: 2010-10
• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2013-08-16
• Last Update Posted: 2013-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trabeculectomy	trabeculectomy	Trabeculectomy with Mitomycin C
Canaloplasty	Canaloplasty	Canaloplasty with implant of suture

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
IOP, medication, complications	2 years	intraocular pressure reduction, medication postoperatively, complications intra- and postoperatively

Trial Locations

Locations (1)

University Eye Hospital; 🇩🇪 Würzburg, Bavaria, Germany