NCT02287545

Brief Summary

Corneal biomechanics are studied in glaucoma patients prior and at least 6 month after trabeculectomy.

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 Feb 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

November 4, 2014

Last Update Submit

August 20, 2015

Conditions

Glaucoma, Primary

Keywords

open angle glaucomacorneal biomechanicstrabeculectomy

Outcome Measures

Primary Outcomes (1)

  • Corneal biomechanical changes following trabeculectomy

    Evaluation of biomechanical properties of the cornea before and after trabeculectomy to evaluate whether intraocular pressure is accurately measured after trabeculectomy. Corneal hysteresis and corneal resistance factor as measured with the Ocular Response Analyzer and the corneal deformation response to an air-puff as measured with an ultra-high-speed Scheimpflug camera are assessed.

    2-3 years

Secondary Outcomes (1)

  • Intraocular pressure after trabeculectomy

    2-3 years

Study Arms (1)

Glaucoma, primary

Glaucoma patients undergoing trabeculectomy

Procedure: trabeculectomy

Interventions

trabeculectomyPROCEDURE

Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control taking maximally tolerated IOP-reducing medication, visual field progression despite maximally tolerated IOP-reducing medication, adverse events because of maximally tolerated IOP-reducing medication or nono.compliance.

Also known as: filtering glaucoma surgery
Glaucoma, primary

Eligibility Criteria

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

Primary open-angle glaucoma patients assigened for a trabeculectomy.

You may qualify if:

  • Glaucoma patients in need of further IOP-reduction despite maximally tolerated therapy and assigned for trabeculectomy. Minimum of 18 years.

You may not qualify if:

  • Corneal pathologies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technical University Dresden

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-Angle

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Karin R Pillunat, MD

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Senior Doctor

Study Record Dates

First Submitted

November 4, 2014

First Posted

November 10, 2014

Study Start

February 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

DE(1)