Clinical trial NCT04475900: Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal Ectasia
Corneal Disease
Corneal Astigmatism
Keratoconus
Glaucoma
Open Angle Glaucoma
Normal Tension Glaucoma
Keywords: Cornea
Ectasia
Keratoconus
Finite Element Modelling
computer-aided data analysis
Glaucoma
Corneal biomechanics
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Fraunhofer Institute for Ceramic Technologies and Systems IKTS
First posted: 2020-07-17
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with corneal ectasia or glaucoma. Healthy eyes that matching to ocular disease groups concerning age.

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.

Eligibility criteria: 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

Primary outcomes:
measure: New biomechanical parameters of the cornea
timeFrame: 2 years
Secondary outcomes:
measure: Dependence of new biomechanical Parameters of the cornea from influencing factors
timeFrame: 1 year
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden
state: Saxony
Study officials:
References: