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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 : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Gerhard Garhofer, Medical University of Vienna

Tracking Information
First Submitted Date  ICMJE February 19, 2014
First Posted Date  ICMJE September 9, 2015
Last Update Posted Date December 29, 2017
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
Change in ocular rigidity [ Time Frame: Baseline and 28±7 days postoperative ]
Change in ocular rigidity after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02544646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2015)
  • Fundus pulsation amplitude [ Time Frame: Baseline and 28±7 days postoperative ]
  • Ocular pulse amplitude [ Time Frame: Baseline and 28±7 days postoperative ]
  • Mean arterial pressure [ Time Frame: Baseline and 28±7 days postoperative ]
  • Pulse rate [ Time Frame: Baseline and 28±7 days postoperative ]
  • Axial eye length [ Time Frame: Baseline and 28±7 days postoperative ]
  • choroidal thickness [ Time Frame: Baseline and 28±7 days postoperative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG
Official Title  ICMJE Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG or PEX
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Glaucoma
  • Primary Open Angle Glaucoma
  • Pseudoexfoliation Glaucoma
Intervention  ICMJE Other: Changes in Ocular rigidity
measured before the operation and 28±7 days after the operation
Study Arms  ICMJE trabeculectomy
Intervention: Other: Changes in Ocular rigidity
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 4, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02544646
Other Study ID Numbers  ICMJE OPHT-040411
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerhard Garhofer, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medical University of Vienna
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP