NCT01391676

Brief Summary

The aim of this study is imaging of trabeculectomy blebs regarding structure and function with the spectral domain optical coherence tomography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 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

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

9 months

First QC Date

July 8, 2011

Last Update Submit

September 9, 2013

Conditions

GlaucomaFiltering Blebs

Keywords

glaucomatrabeculectomyfiltering blebspectral domain optical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • grading of filtering bleb

    December 2011

Study Arms (1)

Trabeculectomy

glaucoma patients undergoing trabeculectomy with mitomycin c 0,02%

Procedure: trabeculectomy

Interventions

trabeculectomyPROCEDURE

postoperative imaging of trabeculectomy blebs with the spectral domain optical coherence tomography

Trabeculectomy

Eligibility Criteria

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

glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure (IOP)

You may qualify if:

  • glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure, informed consent

You may not qualify if:

  • patient without glaucoma, under 18 years of age, not willing to take part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Clinic Dresden

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Karin R Hornykewycz, MD

    University Eye Clinic Dresden, Fetscherstrasse 74, 01307 Dresden, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2011

First Posted

July 12, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

DE(1)