Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties

NCT ID: NCT06914817

Last Updated: 2025-04-06

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2025-10-01

Brief Summary

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This study aims to explore the mechanical properties of the cornea using a non-invasive imaging technique called Brillouin microscopy. This innovative method measures corneal elasticity by detecting small shifts in light frequency, which occur due to interactions with acoustic waves in the tissue. These measurements can provide insights into how corneal stiffness is altered in various eye diseases or after surgery.

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.

Detailed Description

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Conditions

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Map Dot Fingerprint Dystrophy Post-penetrating Keratoplasty Post-Descemet Membrane Endothelial Keratoplasty Healthy Corneas Fuchs Endothelial Dystrophy Ost-Descemet Stripping Automated Endothelial Keratoplasty

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fuchs' Endothelial Dystrophy (FED) Group

Group Type OTHER

Brillouin optical scanning system (Intelon Optics) (BOSS)

Intervention Type DEVICE

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

Group Type OTHER

Brillouin optical scanning system (Intelon Optics) (BOSS)

Intervention Type DEVICE

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

Group Type OTHER

Brillouin optical scanning system (Intelon Optics) (BOSS)

Intervention Type DEVICE

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

Group Type OTHER

Brillouin optical scanning system (Intelon Optics) (BOSS)

Intervention Type DEVICE

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

Group Type OTHER

Brillouin optical scanning system (Intelon Optics) (BOSS)

Intervention Type DEVICE

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

Group Type OTHER

Brillouin optical scanning system (Intelon Optics) (BOSS)

Intervention Type DEVICE

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

Group Type OTHER

Brillouin optical scanning system (Intelon Optics) (BOSS)

Intervention Type DEVICE

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

Group Type OTHER

Brillouin optical scanning system (Intelon Optics) (BOSS)

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent prior to surgery
* 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

Any of the following will exclude a subject from the study:

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role lead

Responsible Party

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Prim. Prof. Dr. Oliver Findl, MBA

Prim. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VIROS - a Karl Landsteiner Institute

Vienna, Austria, Austria

Site Status

Countries

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Austria

Central Contacts

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Daria Amon, MD

Role: CONTACT

+436769576114

Facility Contacts

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Oliver Findl, Prof. MD. MBA

Role: primary

01 9102157564

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.

Reference Type BACKGROUND
PMID: 39120013 (View on PubMed)

Other Identifiers

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BMC

Identifier Type: -

Identifier Source: org_study_id

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