Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG

February 19, 2020 updated by: Gerhard Garhofer, Medical University of Vienna

Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG or PEX

It has been hypothesized that the biomechanical properties of the optic nerve head and/or sclera play a role in the development of glaucoma. One approach of gaining insight into the biomechanical properties of the eye by the means of clinical studies is based on the Friedenwald equation, representing a pressure-volume relationship. This equation represents the so called ocular rigidity, which expresses the elasticity of the globe.

In order to be able to solve the equation, measurements of fundus pulsation amplitude (FPA) with laser interferometry and dynamic contour tonometric assessment of the pulse amplitude (PA) have to be performed.

In addition choroidal thickness will be assessed with OCT before and after trabeculectomy, since results in choroidal thickness measurements in patients with glaucoma are controversial.

The focus of this study lies on the changes of ocular rigidity and choroidal thickness after surgical trabeculectomy in patients with primary open angle glaucoma (POAG) or pseudoexfoliation glaucoma (PEX).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Department of Clinical Pharmacology, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged over 18 years
  • Normal ophthalmic findings except POAG or Pseudoexfoliation glaucoma (PEX)
  • Patients scheduled for trabeculectomy

Exclusion Criteria:

  • Participation in a clinical trial in the 3 weeks preceeding the study
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
  • Other types of glaucoma, such as pigmentary glaucoma, history of acute angle closure
  • History of previous glaucoma surgery
  • Postoperative IOP ≤ 8 mmHg
  • Ocular inflammation or infection within the past 3 months
  • Topical treatment with any ophthalmic drug except anti-glaucomatous medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: trabeculectomy
Other: Changes in Ocular rigidity
measured before the operation and 28±7 days after the operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ocular rigidity
Time Frame: Baseline and 28±7 days postoperative
Change in ocular rigidity after surgery
Baseline and 28±7 days postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Fundus pulsation amplitude
Time Frame: Baseline and 28±7 days postoperative
Baseline and 28±7 days postoperative
Ocular pulse amplitude
Time Frame: Baseline and 28±7 days postoperative
Baseline and 28±7 days postoperative
Mean arterial pressure
Time Frame: Baseline and 28±7 days postoperative
Baseline and 28±7 days postoperative
Pulse rate
Time Frame: Baseline and 28±7 days postoperative
Baseline and 28±7 days postoperative
Axial eye length
Time Frame: Baseline and 28±7 days postoperative
Baseline and 28±7 days postoperative
choroidal thickness
Time Frame: Baseline and 28±7 days postoperative
Baseline and 28±7 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2011

Primary Completion (Actual)

June 8, 2017

Study Completion (Actual)

June 8, 2017

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 9, 2015

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPHT-040411

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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