Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedApril 6, 2025
April 1, 2025
6 months
March 25, 2025
April 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Brillouin shifts
This study aims to use Brillouin microscopy to compare corneal elasticity, measured in Brillouin shifts (GHz) among patients who have undergone corneal surgeries (PKP, DSAEK, DMEK), those with Map Dot Fingerprint Dystrophy (MDFD), and patients with Fuchs' Endothelial Dystrophy (FED). Outcome variables: * Correlation between Brillouin shifts in eyes post corneal surgery (PKP, DSAEK or DMEK) compared to healthy controls * Correlation between Brillouin shifts in eyes before corneal surgery compared to after corneal surgery (PKP, DSAEK or DMEK) * Correlation between Brillouin shifts in eyes with MDFD compared to healthy controls * Correlation between Brillouin shifts in eyes with FED compared to healthy controls
5 months
Study Arms (8)
Fuchs' Endothelial Dystrophy (FED) Group
OTHERMap Dot Fingerprint Dystrophy (MDFD) Group
OTHERPost-Penetrating Keratoplasty (PKP) Group
OTHERPost-DSAEK Group
OTHERPost-DMEK Group
OTHERPre- and Post-DSAEK Group
OTHERPre- and Post-DMEK Group
OTHERHealthy Control Group
OTHERInterventions
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
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VIROS - a Karl Landsteiner Institute
Vienna, Austria, 1140, Austria
Related Publications (1)
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.
PMID: 39120013BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prim. Prof. Dr.
Study Record Dates
First Submitted
March 25, 2025
First Posted
April 6, 2025
Study Start
April 1, 2025
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
April 6, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share