Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG
Primary Purpose
Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Changes in Ocular rigidity
Sponsored by
About this trial
This is an interventional diagnostic trial for Glaucoma focused on measuring trabeculectomy
Eligibility 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
Sites / Locations
- Department of Clinical Pharmacology, Medical University of Vienna
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
trabeculectomy
Arm Description
Outcomes
Primary Outcome Measures
Change in ocular rigidity
Change in ocular rigidity after surgery
Secondary Outcome Measures
Fundus pulsation amplitude
Ocular pulse amplitude
Mean arterial pressure
Pulse rate
Axial eye length
choroidal thickness
Full Information
NCT ID
NCT02544646
First Posted
February 19, 2014
Last Updated
February 19, 2020
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT02544646
Brief Title
Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG
Official Title
Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG or PEX
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 13, 2011 (Actual)
Primary Completion Date
June 8, 2017 (Actual)
Study Completion Date
June 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Keywords
trabeculectomy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
trabeculectomy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Changes in Ocular rigidity
Intervention Description
measured before the operation and 28±7 days after the operation
Primary Outcome Measure Information:
Title
Change in ocular rigidity
Description
Change in ocular rigidity after surgery
Time Frame
Baseline and 28±7 days postoperative
Secondary Outcome Measure Information:
Title
Fundus pulsation amplitude
Time Frame
Baseline and 28±7 days postoperative
Title
Ocular pulse amplitude
Time Frame
Baseline and 28±7 days postoperative
Title
Mean arterial pressure
Time Frame
Baseline and 28±7 days postoperative
Title
Pulse rate
Time Frame
Baseline and 28±7 days postoperative
Title
Axial eye length
Time Frame
Baseline and 28±7 days postoperative
Title
choroidal thickness
Time Frame
Baseline and 28±7 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Clinical Pharmacology, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG
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