Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT02544646
Collaborator
(none)
53
1
1
67.8
0.8

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Changes in Ocular rigidity
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG or PEX
Actual Study Start Date :
Oct 13, 2011
Actual Primary Completion Date :
Jun 8, 2017
Actual Study Completion Date :
Jun 8, 2017

Arms and Interventions

Arm Intervention/Treatment
Other: trabeculectomy

Other: Changes in Ocular rigidity
measured before the operation and 28±7 days after the operation

Outcome Measures

Primary Outcome Measures

  1. Change in ocular rigidity [Baseline and 28±7 days postoperative]

    Change in ocular rigidity after surgery

Secondary Outcome Measures

  1. Fundus pulsation amplitude [Baseline and 28±7 days postoperative]

  2. Ocular pulse amplitude [Baseline and 28±7 days postoperative]

  3. Mean arterial pressure [Baseline and 28±7 days postoperative]

  4. Pulse rate [Baseline and 28±7 days postoperative]

  5. Axial eye length [Baseline and 28±7 days postoperative]

  6. choroidal thickness [Baseline and 28±7 days postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Clinical Pharmacology, Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gerhard Garhofer, Assoc.Prof. Priv.-Doz. MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02544646
Other Study ID Numbers:
  • OPHT-040411
First Posted:
Sep 9, 2015
Last Update Posted:
Feb 20, 2020
Last Verified:
Feb 1, 2020
Keywords provided by Gerhard Garhofer, Assoc.Prof. Priv.-Doz. MD, Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 20, 2020