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Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG

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ClinicalTrials.gov Identifier: NCT02544646
Recruitment Status : Recruiting
First Posted : September 9, 2015
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

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
Glaucoma Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma Other: Changes in Ocular rigidity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : October 2011
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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




Primary Outcome Measures :
  1. Change in ocular rigidity [ Time Frame: Baseline and 28±7 days postoperative ]
    Change in ocular rigidity after surgery


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02544646


Contacts
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Contact: Gerhard Garhoefer, MD 00431/40400 ext 29880 gerhard.garhoefer@meduniwien.ac.at
Contact: Ahmed Bata, MD, MSc +43140400 29880 ahmed.bata@meduniwien.ac.at

Locations
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Austria
Department of Clinical Pharmacology, Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Gerhard Garhoefer, MD    00431/40400 ext 29880    gerhard.garhoefer@meduniwien.ac.at   
Principal Investigator: Gerhard Garhoefer, MD         
Sponsors and Collaborators
Medical University of Vienna

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Responsible Party: Gerhard Garhofer, Assoc.Prof. Priv.-Doz. MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02544646     History of Changes
Other Study ID Numbers: OPHT-040411
First Posted: September 9, 2015    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Keywords provided by Gerhard Garhofer, Medical University of Vienna:
trabeculectomy
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Exfoliation Syndrome
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases