EyeTwin: Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics

Sponsor

Technische Universität Dresden (Other)

Overall Status

Completed

CT.gov ID

NCT04475900

Collaborator

Fraunhofer Institute for Ceramic Technologies and Systems IKTS (Other)

372

Enrollment

Location

24.7

Actual Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Ectasia Corneal Disease Corneal Astigmatism Keratoconus Glaucoma Open Angle Glaucoma Normal Tension Glaucoma	Diagnostic Test: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany) Diagnostic Test: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany) Diagnostic Test: Optic nerve head measurement

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.

Study Design

Study Type:

Observational

Actual Enrollment :

372 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official 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

Actual Study Start Date :

Jul 9, 2020

Actual Primary Completion Date :

Apr 30, 2022

Actual Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Healthy Healthy eyes without any signs of ocular diseases	Diagnostic Test: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany) To measure corneal biomechanics with Scheimpflug based tonometry Diagnostic Test: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany) To measure corneal topography and tomography with Scheimpflug tomograph Diagnostic Test: Optic nerve head measurement To measure optic nerve excavation
Ectasia ectasia suspects early, moderate and advanced keratoconus	Diagnostic Test: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany) To measure corneal biomechanics with Scheimpflug based tonometry Diagnostic Test: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany) To measure corneal topography and tomography with Scheimpflug tomograph
Glaucoma Normal Tension glaucoma Primary Open-Angle Glaucoma	Diagnostic Test: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany) To measure corneal biomechanics with Scheimpflug based tonometry Diagnostic Test: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany) To measure corneal topography and tomography with Scheimpflug tomograph Diagnostic Test: Optic nerve head measurement To measure optic nerve excavation

Arm

Intervention/Treatment

Healthy

Healthy eyes without any signs of ocular diseases

Diagnostic Test: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)

To measure corneal biomechanics with Scheimpflug based tonometry

Diagnostic Test: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)

To measure corneal topography and tomography with Scheimpflug tomograph

Diagnostic Test: Optic nerve head measurement

To measure optic nerve excavation

Ectasia

ectasia suspects early, moderate and advanced keratoconus

Diagnostic Test: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)

To measure corneal biomechanics with Scheimpflug based tonometry

Diagnostic Test: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)

To measure corneal topography and tomography with Scheimpflug tomograph

Glaucoma

Normal Tension glaucoma Primary Open-Angle Glaucoma

Diagnostic Test: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)

To measure corneal biomechanics with Scheimpflug based tonometry

Diagnostic Test: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)

To measure corneal topography and tomography with Scheimpflug tomograph

Diagnostic Test: Optic nerve head measurement

To measure optic nerve excavation

Outcome Measures

Primary Outcome Measures

New biomechanical parameters of the cornea [2 years]
To detemine biomechanical alterations in different ocular diseases and correlate them with other clinical findings