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Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04475900
Acronym
EyeTwin
Enrollment
372
Registered
2020-07-17
Start date
2020-07-09
Completion date
2022-07-31
Last updated
2022-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Astigmatism, Corneal Disease, Corneal Ectasia, Glaucoma, Keratoconus, Normal Tension Glaucoma, Open Angle Glaucoma

Keywords

Cornea, Ectasia, Keratoconus, Finite Element Modelling, computer-aided data analysis, Glaucoma, Corneal biomechanics

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.

Interventions

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

To measure corneal biomechanics with Scheimpflug based tonometry

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

To measure corneal topography and tomography with Scheimpflug tomograph

DIAGNOSTIC_TESTOptic nerve head measurement

To measure optic nerve excavation

Sponsors

Fraunhofer Institute for Ceramic Technologies and Systems IKTS
CollaboratorUNKNOWN
Technische Universität Dresden
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
New biomechanical parameters of the cornea2 yearsTo detemine biomechanical alterations in different ocular diseases and correlate them with other clinical findings

Secondary

MeasureTime frameDescription
Dependence of new biomechanical Parameters of the cornea from influencing factors1 yeare. g. corneal thickness, intraocular pressure

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026