NCT01115218

Brief Summary

The aim of the study is to investigate whether it is possible to predict the success of trabeculectomy in patients with glaucoma through the examination of mediators of wound healing in anterior chamber fluid. The success rate of trabeculectomy with mitomycin C in the literature is about 75%. This leads on the question why 25% of the patients received trabeculectomy are not sufficient treated and have not a long-term IOP reduction. Precisely this question is to be examined by the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

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

October 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

May 3, 2010

Last Update Submit

November 16, 2018

Conditions

GlaucomaTrabeculectomyWound Healing

Keywords

Glaucoma

Study Arms (1)

Glaucoma patients

Procedure: Trabeculectomy

Interventions

TrabeculectomyPROCEDURE

Trabeculectomy with mitomycin C

Glaucoma patients

Eligibility Criteria

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

Patients from the University Eye Hospital of Cologne

You may qualify if:

  • patients with glaucoma with a trabeculectomy required
  • eyes of 60 patients, The ratio of female / male is not involved.
  • Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).
  • age of at least 18 years

You may not qualify if:

  • less than 50yl anterior chamber fluid could be collected during the operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Hospital, University of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Arno Hueber

Study Record Dates

First Submitted

May 3, 2010

First Posted

May 4, 2010

Study Start

October 1, 2009

Primary Completion

January 1, 2010

Study Completion

March 1, 2012

Last Updated

November 20, 2018

Record last verified: 2018-11

Locations

DE(1)