Multidrug Resistance After Trabeculectomy With Mitomycin C | NCT00449631

Studies
Multidrug Resistance After Trabeculectomy With Mitomycin C

NCT00449631

Sponsor

University of Cologne

Status

Completed

Last Update Posted

Mar 26, 2007Estimated

Enrollment

Phase

Not provided

Conditions

Glaucoma
Trabeculectomy

Interventions

Not provided

Countries

Germany

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

Mar 2007

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 19, 2007

First Submission Date that Met QC Criteria

Mar 19, 2007

First Posted Date

Mar 20, 2007Estimated

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

Mar 23, 2007

Last Update Posted Date

Mar 26, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

We investigate whether mitomycin C treatment during previous filtration surgery induces P-glycoprotein expression.

Detailed Description

Despite the adjuvant use of mitomycin C during trabeculectomy, short-term and long-term failures still occur. We investigate whether mitomycin C treatment during previous trabeculectomy induces P-glycoprotein expression. Expression of P-glycoprotein is analysed in surgically removed Tenon tissue using immunohistochemistry.

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with planned trabeculectomy for elevated eye pressure
one third of patients without previous trabeculectomy
two thirds of patients with previous trabeculectomy (one third with and one third without the use of mitomycin C)

Exclusion Criteria:

patients not requiring surgery
patients with planned surgery for elevated eye pressure other than trabeculectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arno Hueber, MD	University of Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University Hospital of Cologne		Cologne		50924	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17934748	Derived	Hueber A, Esser JM, Kociok N, Welsandt G, Luke C, Roters S, Esser PJ. Mitomycin C induces multidrug resistance in glaucoma surgery. Graefes Arch Clin Exp Ophthalmol. 2008 Feb;246(2):297-304. doi: 10.1007/s00417-007-0695-1. Epub 2007 Oct 13.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases