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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01287442
Other study ID # TE-WBCS-IOP
Secondary ID
Status Completed
Phase Phase 4
First received January 28, 2011
Last updated November 3, 2011
Start date January 2009
Est. completion date December 2010

Study information

Verified date November 2011
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Observational

Clinical Trial Summary

It is well established to assess the functionality of a filtering bleb by intraocular pressure (IOP), either as an absolute value or as a percent reduction, and by the need of additional antiglaucoma drugs. It is also possible to evaluate the appearance of a bleb by a clinical score, e.g. the "Wuerzburg bleb classification score" (WBCS). The purpose of this study was to find out whether there is a correlation between clinical findings, in particular IOP and the WBCS.

100 eyes within two years after trabeculectomy were included into the study. Using colour photographs the filtering bleb was evaluated according to the WBCS from two different examiners, both on different levels of clinical experience. WBCS = 1 indicates poor bleb appearance, WBCS = 15 indicates optimal bleb appearance. At the same time, clinical findings like intraocular pressure, best corrected visual acuity, slit lamp biomicroscopy and medical history were taken by another examiner.

- Trial with surgical intervention


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 2010
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria: Diagnosis of glaucoma, status post trabeculectomy

Exclusion criteria: age <18 Jahre, other optic neuropathy than glaucoma

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
Trabeculectomy
A scleral flap is created. The aqueous humor is so guided under the conjunctiva to lower IOP.

Locations

Country Name City State
Switzerland University Hospital Zurich, Ophthalmic Clinic Zurich ZH

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

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