NCT01228799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 27, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 19, 2013

Status Verified

October 1, 2010

Enrollment Period

2.5 years

First QC Date

October 20, 2010

Last Update Submit

August 16, 2013

Conditions

GlaucomaCanaloplastyTrabeculectomy

Keywords

trabeculectomy,canaloplasty,glaucoma surgerynon-penetrating surgery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

  • IOP, medication, complications

    1 year

  • IOP, medication, complications

    2 years

Study Arms (2)

Trabeculectomy

ACTIVE COMPARATOR

Trabeculectomy with Mitomycin C

Procedure: trabeculectomy

Canaloplasty

ACTIVE COMPARATOR

Canaloplasty with implant of suture

Procedure: Canaloplasty

Interventions

trabeculectomyPROCEDURE

trabeculectomy with mitomycin C 0.2mg/ml

Trabeculectomy
CanaloplastyPROCEDURE

Canaloplasty with implant of suture

Canaloplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • angle closure glaucoma
  • congenital glaucoma
  • combined procedures (glaucoma and cataract)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Hospital

Würzburg, Bavaria, 97080, Germany

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Thomas Klink, MD

    University Eye Hospital, Würzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 27, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 19, 2013

Record last verified: 2010-10

Locations

DE(1)