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

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Corneal Astigmatism; Keratoconus; Open Angle Glaucoma; Corneal Ectasia; Corneal Disease; Normal Tension Glaucoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 372

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with corneal ectasia or glaucoma. Healthy eyes that matching to ocular disease groups concerning age.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New biomechanical parameters of the cornea	To detemine biomechanical alterations in different ocular diseases and correlate them with other clinical findings	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dependence of new biomechanical Parameters of the cornea from influencing factors	e. g. corneal thickness, intraocular pressure	1 year

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Collaborators: Fraunhofer Institute for Ceramic Technologies and Systems IKTS

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Cornea; Glaucoma; Keratoconus; Ectasia; Finite Element Modelling; computer-aided data analysis; Corneal biomechanics
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Pathological Conditions, Anatomical; Optic Nerve Diseases; Refractive Errors; Glaucoma; Glaucoma, Open-Angle; Astigmatism; Keratoconus; Dilatation, Pathologic; Corneal Diseases; Low Tension Glaucoma
• Other Study ID Numbers: BO-EK-195052020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No