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

Technische Universität Dresden

Status: Completed

Conditions: Keratoconus; Open Angle Glaucoma; Glaucoma; Corneal Disease; Corneal Astigmatism; Normal Tension Glaucoma; Corneal Ectasia

Treatments: Diagnostic Test: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany); Diagnostic Test: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany); Diagnostic Test: Optic nerve head measurement

Study type: Observational

Funder types: Other

Identifiers

NCT04475900

BO-EK-195052020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 372 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

372 participants in 3 patient groups

Healthy

Description:

Healthy eyes without any signs of ocular diseases

Treatment:

Diagnostic Test: Optic nerve head measurement

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

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

Ectasia

Description:

ectasia suspects early, moderate and advanced keratoconus

Treatment:

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

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

Glaucoma

Description:

Normal Tension glaucoma Primary Open-Angle Glaucoma

Treatment:

Diagnostic Test: Optic nerve head measurement

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

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