NCT01287442

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2011

Completed
Last Updated

November 4, 2011

Status Verified

November 1, 2011

First QC Date

January 28, 2011

Last Update Submit

November 3, 2011

Conditions

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of glaucoma, status post trabeculectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Ophthalmic Clinic

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Furrer S, Menke MN, Funk J, Toteberg-Harms M. Evaluation of filtering blebs using the 'Wuerzburg bleb classification score' compared to clinical findings. BMC Ophthalmol. 2012 Jul 17;12:24. doi: 10.1186/1471-2415-12-24.

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jens Funk, Prof. MD

    University Hospital Zurich, Ophtalmic Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2011

First Posted

February 1, 2011

Study Start

January 1, 2009

Study Completion

December 1, 2010

Last Updated

November 4, 2011

Record last verified: 2011-11

Locations