Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG

Not Applicable

Completed

• Conditions: Glaucoma; Pseudoexfoliation Glaucoma; Primary Open Angle Glaucoma
• Interventions: Other: Changes in Ocular rigidity

• Registration Number: NCT02544646
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-13
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-09
• Primary Completion: 2017-06-08
• Study Completion: 2017-06-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Men and women aged over 18 years
• Normal ophthalmic findings except POAG or Pseudoexfoliation glaucoma (PEX)
• Patients scheduled for trabeculectomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
trabeculectomy	Changes in Ocular rigidity	-

Primary Outcome Measures

Name	Time	Method
Change in ocular rigidity	Baseline and 28±7 days postoperative	Change in ocular rigidity after surgery

Secondary Outcome Measures

Name	Time	Method
Pulse rate	Baseline and 28±7 days postoperative
choroidal thickness	Baseline and 28±7 days postoperative
Mean arterial pressure	Baseline and 28±7 days postoperative
Axial eye length	Baseline and 28±7 days postoperative
Fundus pulsation amplitude	Baseline and 28±7 days postoperative
Ocular pulse amplitude	Baseline and 28±7 days postoperative

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Medical University of Vienna; 🇦🇹 Vienna, Austria