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Trabeculectomy Versus Canaloplasty

NCT ID: NCT01228799

Last Updated: 2013-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Glaucoma Canaloplasty Trabeculectomy

Keywords

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trabeculectomy, canaloplasty, glaucoma surgery non-penetrating surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Trabeculectomy

Trabeculectomy with Mitomycin C

Group Type ACTIVE_COMPARATOR

trabeculectomy

Intervention Type PROCEDURE

trabeculectomy with mitomycin C 0.2mg/ml

Canaloplasty

Canaloplasty with implant of suture

Group Type ACTIVE_COMPARATOR

Canaloplasty

Intervention Type PROCEDURE

Canaloplasty with implant of suture

Interventions

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trabeculectomy

trabeculectomy with mitomycin C 0.2mg/ml

Intervention Type PROCEDURE

Canaloplasty

Canaloplasty with implant of suture

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Eye Hospital, Würzburg

OTHER

Sponsor Role lead

Responsible Party

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University Hospitals Würzburg

Principal Investigators

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Thomas Klink, MD

Role: PRINCIPAL_INVESTIGATOR

University Eye Hospital, Würzburg

Locations

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University Eye Hospital

Würzburg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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TVC

Identifier Type: OTHER

Identifier Source: secondary_id

TVC-1

Identifier Type: -

Identifier Source: org_study_id