Trabeculectomy Versus Canaloplasty (TVC)

University Eye Hospital, Würzburg

Status: Completed

Conditions: Trabeculectomy; Glaucoma; Canaloplasty

Treatments: Procedure: Canaloplasty; Procedure: trabeculectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01228799

TVC (Other Identifier)

TVC-1

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

1. angle closure glaucoma
2. congenital glaucoma
3. combined procedures (glaucoma and cataract)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Trabeculectomy

Active Comparator group

Description:

Trabeculectomy with Mitomycin C

Treatment:

Procedure: trabeculectomy

Canaloplasty

Active Comparator group

Description:

Canaloplasty with implant of suture

Treatment:

Procedure: Canaloplasty