Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-13

Study Completion Date

2017-06-08

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).

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Detailed Description

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Conditions

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Glaucoma Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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trabeculectomy

Group Type OTHER

Changes in Ocular rigidity

Intervention Type OTHER

measured before the operation and 28±7 days after the operation

Interventions

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Changes in Ocular rigidity

measured before the operation and 28±7 days after the operation

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No