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NCT Number: NCT04475900

Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics

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.

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Key information

Conditions

Corneal Ectasia Astigmatism Corneal Astigmatism Corneal Disease Corneal Diseases Dilatation, Pathologic Eye Diseases Glaucoma Glaucoma, Open-Angle Keratoconus Low Tension Glaucoma Normal Tension Glaucoma Ocular Hypertension Open Angle Glaucoma Optic Nerve Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Refractive Errors

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden

Dresden, Saxony, 01307, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)

Diagnostic Test

To measure corneal biomechanics with Scheimpflug based tonometry

Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)

Diagnostic Test

To measure corneal topography and tomography with Scheimpflug tomograph

Optic nerve head measurement

Diagnostic Test

To measure optic nerve excavation

Primary outcomes

  1. 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

  1. Dependence of new biomechanical Parameters of the cornea from influencing factors

    Time frame: 1 year

    e. g. corneal thickness, intraocular pressure

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • Fraunhofer Institute for Ceramic Technologies and Systems IKTS

Registry information

Official study title

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

Acronym: EyeTwin

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 17, 2020
Registry last updated
Aug 11, 2022

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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