Biomechanical Changes After Trabeculectomy

Completed

• Conditions: Glaucoma, Primary
• Interventions: Procedure: trabeculectomy

• Registration Number: NCT02287545
• Lead Sponsor: Technische Universität Dresden

Brief Summary

Corneal biomechanics are studied in glaucoma patients prior and at least 6 month after trabeculectomy.

Detailed Description

Prior to trabeculectomy corneal biomechanics are measured with the Ocular Response Analyzer (ORA, Reichert) and the Corvis st (Oculus). Both instruments work with an air-puff which deforms the cornea. Intraocular pressure is measured like in non-contact air-puff tonometry. The ORA also measures corneal hysteresis (CH) and the corneal resistance factor (CRF) which are qualitative measures of corneal biomechanics. The Corvis is a high-speed Scheimpflug-camera (4330 frames/sec) that records the quantitative movements of the cornea. At least 6 month after uncomplicated trabeculectomy the measurements are repeated.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-11-04
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Glaucoma patients in need of further IOP-reduction despite maximally tolerated therapy and assigned for trabeculectomy. Minimum of 18 years.

Exclusion Criteria

• Corneal pathologies.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Glaucoma, primary	trabeculectomy	Glaucoma patients undergoing trabeculectomy

Primary Outcome Measures

Name	Time	Method
Corneal biomechanical changes following trabeculectomy	2-3 years	Evaluation of biomechanical properties of the cornea before and after trabeculectomy to evaluate whether intraocular pressure is accurately measured after trabeculectomy. Corneal hysteresis and corneal resistance factor as measured with the Ocular Response Analyzer and the corneal deformation response to an air-puff as measured with an ultra-high-speed Scheimpflug camera are assessed.

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure after trabeculectomy	2-3 years	Intraocular pressure is measured with 3 different devices (Goldmann applanation tonometry, Ocular Response Analyzer, Corvis st) prior and at least 6 month after trabeculectomy.

Trial Locations

Locations (1)

Technical University Dresden; 🇩🇪 Dresden, Saxony, Germany