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Clinical Trials/NCT04475900
NCT04475900
Completed
Not Applicable

Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics - Selection and Evaluation of Eligible Patients With Certain Ocular Diseases Associated With Biomechanical Alterations

Technische Universität Dresden1 site in 1 country372 target enrollmentJuly 9, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Corneal Ectasia
Sponsor
Technische Universität Dresden
Enrollment
372
Locations
1
Primary Endpoint
New biomechanical parameters of the cornea
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is the investigation of biomechanical properties of the cornea using computer-aided data analysis. Currently, it is known that keratoconus and glaucoma are ocular disease that are associated with biomechanical alterations of the cornea. Corneal ectasia, especially keratoconus, is a corneal disease that leads to an irreversible loss of visual acuity while the cornea becomes steeper, thinner and irregular. For these patients, surgical intervention (e.g. corneal cross-linking) is performed, in case of disease progression. In glaucoma, the information about corneal alterations serves in two ways, first, correct measurement of intra ocular pressure (IOP); second, early diagnosis of suspects before visual field defects are detectable.

Especially, the Corvis ST is an air-puff tonometer that measures intraocular pressure, corneal thickness (CCT) as well as dynamic corneal response (DCR) parameters. Most of the DCR parameters are affected by IOP and CCT: Therefore, algorithm are needed to determine parameters without impact of IOP and CCT that are describe the biomechanical properties of the cornea.

Detailed Description

In this study, an eye twin based on finite element modeling is used to measure advanced properties of corneal biomechanics. Raw data of Corvis ST measurement are exported from the device and imported into the model. The outcome of these calculations are merged together and are compared to further clinical findings (e. g. corneal topography and tomography, axial eye length). Further information were obtained: Age, sex, refraction, family history, known duration of disease, previous ocular surgery, systemic diseases, systemic and topical medication; biomicroscopy, anterior optical coherence tomography (OCT), Scheimpflug-based tomography (Pentacam), Biomechanical assessment (Ocular Response Analyzer and Corneal Visualization with the Scheimpflug Technology), optical biometry, confocal microscopy, endothelium cell count.

Registry
clinicaltrials.gov
Start Date
July 9, 2020
End Date
July 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • corneal ectasia (keratoconus) or ectasia suspect
  • glaucoma (Primary open angle glaucoma and normal Tension glaucoma) or glaucoma suspect

Exclusion Criteria

  • age under 18 years
  • pregnancy

Outcomes

Primary Outcomes

New biomechanical parameters of the cornea

Time Frame: 2 years

To detemine biomechanical alterations in different ocular diseases and correlate them with other clinical findings

Secondary Outcomes

  • Dependence of new biomechanical Parameters of the cornea from influencing factors(1 year)

Study Sites (1)

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