Evaluation of Filtering Blebs Using the "Wuerzburg Bleb C... | NCT01287442

Studies
Evaluation of Filtering Blebs Using the "Wuerzburg Bleb Classification Score" Compared to Other Clinical Findings, e.g. the Intraocular Pressure (IOP)

NCT01287442

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Nov 4, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Glaucoma

Interventions

Trabeculectomy

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Not provided

Completion Date

Dec 2010

First Submitted Date

Jan 28, 2011

First Submission Date that Met QC Criteria

Jan 28, 2011

First Posted Date

Feb 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2011

Last Update Posted Date

Nov 4, 2011Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trabeculectomy	Procedure	A scleral flap is created. The aqueous humor is so guided under the conjunctiva to lower IOP.

Eligibility Module

Eligibility Criteria

Inclusion criteria: Diagnosis of glaucoma, status post trabeculectomy

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Diagnosis of glaucoma, status post trabeculectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Funk, Prof. MD	University Hospital Zurich, Ophtalmic Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Zurich, Ophthalmic Clinic		Zurich	Canton of Zurich	8091	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22805056	Derived	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.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

ID	Term
D018463	Filtering Surgery
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative