Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics

Completed

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

• Registration Number: NCT04475900
• Lead Sponsor: Technische Universität Dresden

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.

Study Timeline

• Study Start: 2020-07-09
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-17
• Primary Completion: 2022-04-30
• Study Completion: 2022-07-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

Inclusion Criteria

• corneal ectasia (keratoconus) or ectasia suspect
• glaucoma (Primary open angle glaucoma and normal Tension glaucoma) or glaucoma suspect

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Exclusion Criteria

• age under 18 years
• pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)	Healthy eyes without any signs of ocular diseases
Ectasia	Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)	ectasia suspects early, moderate and advanced keratoconus
Healthy	Optic nerve head measurement	Healthy eyes without any signs of ocular diseases
Ectasia	Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)	ectasia suspects early, moderate and advanced keratoconus
Glaucoma	Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)	Normal Tension glaucoma Primary Open-Angle Glaucoma
Glaucoma	Optic nerve head measurement	Normal Tension glaucoma Primary Open-Angle Glaucoma
Healthy	Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)	Healthy eyes without any signs of ocular diseases
Glaucoma	Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)	Normal Tension glaucoma Primary Open-Angle Glaucoma

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Dependence of new biomechanical Parameters of the cornea from influencing factors	1 year	e. g. corneal thickness, intraocular pressure

Trial Locations

Locations (1)

Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden; 🇩🇪 Dresden, Saxony, Germany