Trabeculectomy Versus Canaloplasty to Treat Glaucoma

NCT ID: NCT00854256

Last Updated: 2013-04-15

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-05-31

Brief Summary

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The aim of the study is to investigate pressure lowering effect of two surgical methods canaloplasty and trabeculectomy in patients with open angle glaucoma, in which under local pressure lowering therapy the progression of the disease could not be stopped, and thus a pressure lowering surgical intervention is necessary. The risks in the postoperative course in Canaloplasty in the literature as lower than for the trabeculectomy with mitomycin-C. Conversely, large glaucoma centers questioning the effectiveness of permanent pressure lowering of canaloplasty. Precisely this question is investigated in the study.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Canaloplasty

Group Type EXPERIMENTAL

Canaloplasty

Intervention Type PROCEDURE

Canaloplasty surgery

Trabeculectomy with mitomycin C

Group Type ACTIVE_COMPARATOR

Trabeculectomy with mitomycin C

Intervention Type PROCEDURE

Trabeculectomy with mitomycin C surgery

Interventions

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Canaloplasty

Canaloplasty surgery

Intervention Type PROCEDURE

Trabeculectomy with mitomycin C

Trabeculectomy with mitomycin C surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with open angle glaucoma and excavation of 0.4 - 0.8
* 60 eyes of 60 patients (30 patients for trabeculectomy, 30 patients for Canaloplasty) The ratio of female / male is not involved.
* Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).
* Local drug therapy: at least 2 eye pressure lowering ingredients or absolute intolerance to preservatives or eye drops.
* general anesthesia possible.
* The operation must be signed by the surgeon as a state-of-the-art performed without complication to be evaluated. If the operation does not meet this criterion, the patient is excluded from the study.

* Phenprocoumon therapy.
* operation is not done state-of-the-art.
* after the surgery: additional eye pressure lowering surgery, cataract surgery, keratoplasty, laser surgery in the anterior eye segment (except suture lysis after trabeculectomy)
* Uveitis, or possible inflammation of the eye
* Previous eye pressure lowering operations or laser interventions
* Corneal Refractive Surgery (pseudophakia allowed)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iScience Interventional Corporation

INDUSTRY

Sponsor Role collaborator

University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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University of Cologne

Locations

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Centre of Ophthalmology, University of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Gerhard Welsandt, MD

Role: CONTACT

+49-221-478-0

Other Identifiers

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iScience-022-CG

Identifier Type: -

Identifier Source: org_study_id

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