Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544646
• Other study ID #: OPHT-040411
• Status: Completed
• Phase: N/A
• Start date: October 13, 2011
• Est. completion date: June 8, 2017

Study information

• Verified date: February 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 8, 2017
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma
• Pseudoexfoliation Glaucoma

Intervention

Other:
• Changes in Ocular rigidity
measured before the operation and 28±7 days after the operation

Locations

Country	Name	City	State
Austria	Department of Clinical Pharmacology, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ocular rigidity	Change in ocular rigidity after surgery	Baseline and 28±7 days postoperative
Secondary	Fundus pulsation amplitude		Baseline and 28±7 days postoperative
Secondary	Ocular pulse amplitude		Baseline and 28±7 days postoperative
Secondary	Mean arterial pressure		Baseline and 28±7 days postoperative
Secondary	Pulse rate		Baseline and 28±7 days postoperative
Secondary	Axial eye length		Baseline and 28±7 days postoperative
Secondary	choroidal thickness		Baseline and 28±7 days postoperative