Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties
NCT ID: NCT06914817
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-04-01
2025-10-01
Brief Summary
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The study includes 100 participants, divided into different groups: patients with Fuchs' Endothelial Dystrophy (FED), Map Dot Fingerprint Dystrophy (MDFD), and those who have undergone corneal surgeries such as Penetrating Keratoplasty (PKP), Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK), and Descemet Membrane Endothelial Keratoplasty (DMEK). Healthy individuals will also be studied as a control group.
Participants will first receive a standard eye exam, including a slit-lamp examination. Then, Brillouin microscopy will be used to measure the cornea's mechanical stiffness. Additional tests include optical coherence tomography (OCT), corneal topography and tomography, pachymetry (measuring corneal thickness), endothelial cell count, and intraocular pressure (IOP) measurement.
The purpose of this study is to better understand how diseases and surgeries affect corneal biomechanics. The researchers will also examine how well the Brillouin measurements match with findings from other clinical imaging tests. The results may help improve diagnosis and treatment options for corneal disorders.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Fuchs' Endothelial Dystrophy (FED) Group
Brillouin optical scanning system (Intelon Optics) (BOSS)
Brillouin microscopy is a non-invasive optical imaging technique that measures the mechanical properties of tissues, such as stiffness and elasticity, by analyzing light scattering caused by natural acoustic waves within the tissue.
Map Dot Fingerprint Dystrophy (MDFD) Group
Brillouin optical scanning system (Intelon Optics) (BOSS)
Brillouin microscopy is a non-invasive optical imaging technique that measures the mechanical properties of tissues, such as stiffness and elasticity, by analyzing light scattering caused by natural acoustic waves within the tissue.
Post-Penetrating Keratoplasty (PKP) Group
Brillouin optical scanning system (Intelon Optics) (BOSS)
Brillouin microscopy is a non-invasive optical imaging technique that measures the mechanical properties of tissues, such as stiffness and elasticity, by analyzing light scattering caused by natural acoustic waves within the tissue.
Post-DSAEK Group
Brillouin optical scanning system (Intelon Optics) (BOSS)
Brillouin microscopy is a non-invasive optical imaging technique that measures the mechanical properties of tissues, such as stiffness and elasticity, by analyzing light scattering caused by natural acoustic waves within the tissue.
Post-DMEK Group
Brillouin optical scanning system (Intelon Optics) (BOSS)
Brillouin microscopy is a non-invasive optical imaging technique that measures the mechanical properties of tissues, such as stiffness and elasticity, by analyzing light scattering caused by natural acoustic waves within the tissue.
Pre- and Post-DSAEK Group
Brillouin optical scanning system (Intelon Optics) (BOSS)
Brillouin microscopy is a non-invasive optical imaging technique that measures the mechanical properties of tissues, such as stiffness and elasticity, by analyzing light scattering caused by natural acoustic waves within the tissue.
Pre- and Post-DMEK Group
Brillouin optical scanning system (Intelon Optics) (BOSS)
Brillouin microscopy is a non-invasive optical imaging technique that measures the mechanical properties of tissues, such as stiffness and elasticity, by analyzing light scattering caused by natural acoustic waves within the tissue.
Healthy Control Group
Brillouin optical scanning system (Intelon Optics) (BOSS)
Brillouin microscopy is a non-invasive optical imaging technique that measures the mechanical properties of tissues, such as stiffness and elasticity, by analyzing light scattering caused by natural acoustic waves within the tissue.
Interventions
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Brillouin optical scanning system (Intelon Optics) (BOSS)
Brillouin microscopy is a non-invasive optical imaging technique that measures the mechanical properties of tissues, such as stiffness and elasticity, by analyzing light scattering caused by natural acoustic waves within the tissue.
Eligibility Criteria
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Inclusion Criteria
* Patients aged 18 years and older
* Patients who have undergone one of the following corneal surgeries or are diagnosed with one of the following dystrophies:
* Penetrating Keratoplasty (PKP) and no longer have sutures following PKP o Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
* Descemet Membrane Endothelial Keratoplasty (DMEK)
* Fuchs' Endothelial Dystrophy (FED)
* Map Dot Fingerprint Dystrophy (MDFD)
* Healthy Controls: healthy eyes without any history of corneal diseases or surgeries
Exclusion Criteria
* Patients with inadequate corneal imaging or corneal scarring that would impact results
* Patients with other corneal dystrophies or corneal diseases
* Patients with active ocular infections or inflammatory conditions
* Patients unable to undergo Brillouin imaging adequately
* Patients that suffered an eye trauma according to their medical history
* Patients with fixational problems (e.g., head tremor) or with any medical condition that could interfere with the measurements
* Pregnancy (pregnancy test will be performed in women of reproductive age)
18 Years
ALL
Yes
Sponsors
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Vienna Institute for Research in Ocular Surgery
OTHER
Responsible Party
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Prim. Prof. Dr. Oliver Findl, MBA
Prim. Prof. Dr.
Locations
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VIROS - a Karl Landsteiner Institute
Vienna, Austria, Austria
Countries
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Central Contacts
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Facility Contacts
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References
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Vinciguerra R, Palladino S, Herber R, Romano MR, Vinciguerra P. The KERATO Biomechanics Study 1: A Comparative Evaluation Using Brillouin Microscopy and Dynamic Scheimpflug Imaging. J Refract Surg. 2024 Aug;40(8):e569-e578. doi: 10.3928/1081597X-20240701-02. Epub 2024 Aug 1.
Other Identifiers
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BMC
Identifier Type: -
Identifier Source: org_study_id
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