Corneal EctasiaEyeTwinNCT04475900
Computer-aided Diagnosis of Ocular Diseases Based on Corneal Biomechanics
An observational study of Corneal Ectasia and Corneal Disease, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Ectasia, Corneal Disease, Corneal Astigmatism
- What is being tested?
- Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany), Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany) and Optic nerve head measurement
- How many people
- 372 participants
- Where
- 1 siteGermany
- Study dates
- 9 Jul 2020to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with corneal ectasia or glaucoma. Healthy eyes that matching to ocular disease groups concerning age.
Who may be able to join
- corneal ectasia (keratoconus) or ectasia suspect
- glaucoma (Primary open angle glaucoma and normal Tension glaucoma) or glaucoma suspect
Who cannot join
- age under 18 years
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Ophthalmology; Medical Faculty Carl Gustav Carus; Technical University Dresden
Dresden, Saxony, 01307
About this study
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
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.
Read the 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.
- Conditions
- Corneal Ectasia, Corneal Disease, Corneal Astigmatism, Keratoconus, Glaucoma, Open Angle Glaucoma
- Being tested
- Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany), Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany), Optic nerve head measurement
- Keywords
- Cornea, Ectasia, Keratoconus, Finite Element Modelling, computer-aided data analysis, Glaucoma, Corneal biomechanics
- Medical subject headings
- Corneal Diseases, Astigmatism, Keratoconus, Glaucoma, Glaucoma, Open-Angle, Low Tension Glaucoma, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)Diagnostic test
To measure corneal biomechanics with Scheimpflug based tonometry
Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)Diagnostic test
To measure corneal topography and tomography with Scheimpflug tomograph
Optic nerve head measurementDiagnostic test
To measure optic nerve excavation
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy eyes without any signs of ocular diseases Receives: 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
New biomechanical parameters of the cornea
To detemine biomechanical alterations in different ocular diseases and correlate them with other clinical findings
Measured: 2 years
Secondary outcomes (1)
Dependence of new biomechanical Parameters of the cornea from influencing factors
- g. corneal thickness, intraocular pressure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start9 Jul 2020
- Primary completion30 Apr 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EctasiaStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Fraunhofer Institute for Ceramic Technologies and Systems IKTS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475900
- Sponsor's protocol ID
- BO-EK-195052020
- Acronym
- EyeTwin
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2020
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04475900
- Acronym / sponsor ID
- EyeTwin / BO-EK-195052020
- Conditions
- Corneal Ectasia, Corneal Disease, Corneal Astigmatism, Keratoconus, Glaucoma, Open Angle Glaucoma
- Keywords
- Cornea, Ectasia, Keratoconus, Finite Element Modelling, computer-aided data analysis, Glaucoma, Corneal biomechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Fraunhofer Institute for Ceramic Technologies and Systems IKTS
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Diagnostic Test: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany), Diagnostic Test: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany), Diagnostic Test: Optic nerve head measurementHealthy eyes without any signs of ocular diseases |
| Ectasia | – | Diagnostic Test: Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany), Diagnostic Test: Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)ectasia suspects early, moderate and advanced keratoconus |
| 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 measurementNormal Tension glaucoma Primary Open-Angle Glaucoma |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with corneal ectasia or glaucoma. Healthy eyes that matching to ocular disease groups concerning age.
Key inclusion criteria (2 listed)
- corneal ectasia (keratoconus) or ectasia suspect
- glaucoma (Primary open angle glaucoma and normal Tension glaucoma) or glaucoma suspect
Key exclusion criteria (2 listed)
- age under 18 years
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)To measure corneal biomechanics with Scheimpflug based tonometry | Diagnostic test | Ectasia, Glaucoma, Healthy |
| Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)To measure corneal topography and tomography with Scheimpflug tomograph | Diagnostic test | Ectasia, Glaucoma, Healthy |
| Optic nerve head measurementTo measure optic nerve excavation | Diagnostic test | Glaucoma, Healthy |
Primary outcome
New biomechanical parameters of the cornea
Time frame: 2 years
To detemine biomechanical alterations in different ocular diseases and correlate them with other clinical findings
1 secondary outcome
Dependence of new biomechanical Parameters of the cornea from influencing factors
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Ectasia and Corneal Disease, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New biomechanical parameters of the cornea (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.