Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics

NCT04475900 | Completed FDA Device

• 1 other identifier: BO-EK-195052020
• Study Type: observational
• Target: 372
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• New biomechanical parameters of the cornea

  To detemine biomechanical alterations in different ocular diseases and correlate them with other clinical findings

  2 years

Secondary Outcomes (1)

• Dependence of new biomechanical Parameters of the cornea from influencing factors

  1 year

Study Arms (3)

Healthy

Healthy eyes without any signs of ocular diseases

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

Ectasia

ectasia suspects early, moderate and advanced keratoconus

Diagnostic Test: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany); Diagnostic Test: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)

Glaucoma

Normal Tension glaucoma Primary Open-Angle Glaucoma

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

Interventions

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

To measure corneal biomechanics with Scheimpflug based tonometry

Ectasia; Glaucoma; Healthy

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

To measure corneal topography and tomography with Scheimpflug tomograph

Ectasia; Glaucoma; Healthy

Optic nerve head measurement DIAGNOSTIC_TEST

To measure optic nerve excavation

Glaucoma; Healthy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with corneal ectasia or glaucoma. Healthy eyes that matching to ocular disease groups concerning age.

You may qualify if:

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

You may not qualify if:

• age under 18 years
• pregnancy

Sponsors & Collaborators

• Technische Universität Dresden: lead
• Fraunhofer Institute for Ceramic Technologies and Systems IKTS: collaborator

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Corneal Diseases; Astigmatism; Keratoconus; Glaucoma; Glaucoma, Open-Angle; Low Tension Glaucoma; Dilatation, Pathologic

Interventions

Vision, Ocular; Corneal Topography; Tomography

Condition Hierarchy (Ancestors)

Eye Diseases; Refractive Errors; Ocular Hypertension; Optic Nerve Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Light Signal Transduction; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Cell Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 17, 2020
• Study Start: July 9, 2020
• Primary Completion: April 30, 2022
• Study Completion: July 31, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

DE (1)