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Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02544646
Enrollment
53
Registered
2015-09-09
Start date
2011-10-13
Completion date
2017-06-08
Last updated
2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma

Keywords

trabeculectomy

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).

Interventions

OTHERChanges in Ocular rigidity

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

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in ocular rigidityBaseline and 28±7 days postoperativeChange in ocular rigidity after surgery

Secondary

MeasureTime frame
Ocular pulse amplitudeBaseline and 28±7 days postoperative
Mean arterial pressureBaseline and 28±7 days postoperative
Fundus pulsation amplitudeBaseline and 28±7 days postoperative
Axial eye lengthBaseline and 28±7 days postoperative
choroidal thicknessBaseline and 28±7 days postoperative
Pulse rateBaseline and 28±7 days postoperative

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026