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OpenTrials
Completed

NCT Number: NCT02544646

Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG

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).

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Key information

Conditions

Glaucoma Exfoliation Syndrome Eye Diseases Glaucoma, Open-Angle Iris Diseases Ocular Hypertension Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Changes in Ocular rigidity

Other

measured before the operation and 28±7 days after the operation

Primary outcomes

  1. Change in ocular rigidity

    Time frame: Baseline and 28±7 days postoperative

    Change in ocular rigidity after surgery

Secondary outcomes

  1. Fundus pulsation amplitude

    Time frame: Baseline and 28±7 days postoperative

  2. Ocular pulse amplitude

    Time frame: Baseline and 28±7 days postoperative

  3. Mean arterial pressure

    Time frame: Baseline and 28±7 days postoperative

  4. Pulse rate

    Time frame: Baseline and 28±7 days postoperative

  5. Axial eye length

    Time frame: Baseline and 28±7 days postoperative

  6. choroidal thickness

    Time frame: Baseline and 28±7 days postoperative

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Sep 9, 2015
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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