Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics

Glaucoma Clinical Trial

— EyeTwin  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475900
• Other study ID #: BO-EK-195052020
• Status: Completed
• Start date: July 9, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: July 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Corneal Astigmatism
• Corneal Disease
• Corneal Diseases
• Corneal Ectasia
• Glaucoma
• Glaucoma, Open-Angle
• Keratoconus
• Low Tension Glaucoma
• Normal Tension Glaucoma
• Open Angle Glaucoma

Intervention

Diagnostic Test:
• Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)
To measure corneal biomechanics with Scheimpflug based tonometry
• Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)
To measure corneal topography and tomography with Scheimpflug tomograph
• Optic nerve head measurement
To measure optic nerve excavation

Locations

Country	Name	City	State
Germany	Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden	Dresden	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	Fraunhofer Institute for Ceramic Technologies and Systems IKTS

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New biomechanical parameters of the cornea	To detemine biomechanical alterations in different ocular diseases and correlate them with other clinical findings	2 years
Secondary	Dependence of new biomechanical Parameters of the cornea from influencing factors	e. g. corneal thickness, intraocular pressure	1 year