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Clinical Trials/NCT02287545
NCT02287545CompletedNot Applicable

Corneal Biomechanical Changes Following Trabeculectomy

Technische Universität Dresden1 site in 1 country30 target enrollmentStarted: February 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Corneal biomechanical changes following trabeculectomy

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

  • Intraocular pressure after trabeculectomy(2-3 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Karin Pillunat

Medical Senior Doctor

Technische Universität Dresden

Study Sites (1)

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