Changes in Ocular Rigidity After Trabeculectomy in Patients With POAG

NCT02544646 | Completed

• 1 other identifier: OPHT-040411
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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).

Conditions

Glaucoma; Primary Open Angle Glaucoma; Pseudoexfoliation Glaucoma

Keywords

trabeculectomy

Outcome Measures

Primary Outcomes (1)

• Change in ocular rigidity

  Change in ocular rigidity after surgery

  Baseline and 28±7 days postoperative

Secondary Outcomes (6)

• 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

Study Arms (1)

trabeculectomy

OTHER

Other: Changes in Ocular rigidity

Interventions

Changes in Ocular rigidity OTHER

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

trabeculectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Exfoliation Syndrome

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Iris Diseases; Uveal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof. Priv.-Doz. MD

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: September 9, 2015
• Study Start: October 13, 2011
• Primary Completion: June 8, 2017
• Study Completion: June 8, 2017
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

AU (1)