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Completed

NCT Number: NCT02287545

Biomechanical Changes After Trabeculectomy

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

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Key information

Conditions

Glaucoma, Primary Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Technical University Dresden

Dresden, Saxony, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

trabeculectomy

Procedure

Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control taking maximally tolerated IOP-reducing medication, visual field progression despite maximally tolerated IOP-reducing medication, adverse events because of maximally tolerated IOP-reducing medication or nono.compliance.

Other names: filtering glaucoma surgery

Primary outcomes

  1. Corneal biomechanical changes following trabeculectomy

    Time frame: 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 outcomes

  1. Intraocular pressure after trabeculectomy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

Corneal Biomechanical Changes Following Trabeculectomy

Acronym: TE-biomech

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 10, 2014
Registry last updated
Aug 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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