Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics

NCT ID: NCT04475900

Last Updated: 2022-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-09

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy

Healthy eyes without any signs of ocular diseases

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

Intervention Type DIAGNOSTIC_TEST

To measure corneal biomechanics with Scheimpflug based tonometry

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

Intervention Type DIAGNOSTIC_TEST

To measure corneal topography and tomography with Scheimpflug tomograph

Optic nerve head measurement

Intervention Type DIAGNOSTIC_TEST

To measure optic nerve excavation

Ectasia

ectasia suspects early, moderate and advanced keratoconus

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

Intervention Type DIAGNOSTIC_TEST

To measure corneal biomechanics with Scheimpflug based tonometry

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

Intervention Type DIAGNOSTIC_TEST

To measure corneal topography and tomography with Scheimpflug tomograph

Glaucoma

Normal Tension glaucoma Primary Open-Angle Glaucoma

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

Intervention Type DIAGNOSTIC_TEST

To measure corneal biomechanics with Scheimpflug based tonometry

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

Intervention Type DIAGNOSTIC_TEST

To measure corneal topography and tomography with Scheimpflug tomograph

Optic nerve head measurement

Intervention Type DIAGNOSTIC_TEST

To measure optic nerve excavation

Interventions

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

To measure corneal biomechanics with Scheimpflug based tonometry

Intervention Type DIAGNOSTIC_TEST

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

To measure corneal topography and tomography with Scheimpflug tomograph

Intervention Type DIAGNOSTIC_TEST

Optic nerve head measurement

To measure optic nerve excavation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fraunhofer Institute for Ceramic Technologies and Systems IKTS

UNKNOWN

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Dresden, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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BO-EK-195052020

Identifier Type: -

Identifier Source: org_study_id

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