Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG

Study Overview
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Brief Summary
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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).

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

Conditions
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Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma

Intervention / Treatment
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* Other: Changes in Ocular rigidity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: trabeculectomy<br> | Other: Changes in Ocular rigidity<br>* measured before the operation and 28±7 days after the operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular rigidity | Change in ocular rigidity after surgery | Baseline and 28±7 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fundus pulsation amplitude |  | Baseline and 28±7 days postoperative | 
| Ocular pulse amplitude |  | Baseline and 28±7 days postoperative | 
| Mean arterial pressure |  | Baseline and 28±7 days postoperative | 
| Pulse rate |  | Baseline and 28±7 days postoperative | 
| Axial eye length |  | Baseline and 28±7 days postoperative | 
| choroidal thickness |  | Baseline and 28±7 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trabeculectomy