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Not yet recruitingNCT06914817Updated Apr 6, 2025

Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties

An interventional study of Brillouin optical scanning system (Intelon Optics) (BOSS) in Map Dot Fingerprint Dystrophy, Post-penetrating Keratoplasty and Post-Descemet Membrane Endothelial Keratoplasty, sponsored by Vienna Institute for Research in Ocular Surgery. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by Vienna Institute for Research in Ocular Surgery · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Map Dot Fingerprint Dystrophy
  • Post-penetrating Keratoplasty
  • Post-Descemet Membrane Endothelial Keratoplasty
  • Healthy Corneas
  • Fuchs Endothelial Dystrophy
  • Ost-Descemet Stripping Automated Endothelial Keratoplasty
03

In context

Fuchs' Endothelial Dystrophy

92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.

Browse Fuchs' Endothelial Dystrophy studies →

Lead sponsor

Vienna Institute for Research in Ocular Surgery is the lead sponsor of 65 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written 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

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    Fuchs' Endothelial Dystrophy (FED) Group

    Device: Brillouin optical scanning system (Intelon Optics) (BOSS)

  • Other
    Map Dot Fingerprint Dystrophy (MDFD) Group

    Device: Brillouin optical scanning system (Intelon Optics) (BOSS)

  • Other
    Post-Penetrating Keratoplasty (PKP) Group

    Device: Brillouin optical scanning system (Intelon Optics) (BOSS)

  • Other
    Post-DSAEK Group

    Device: Brillouin optical scanning system (Intelon Optics) (BOSS)

  • Other
    Post-DMEK Group

    Device: Brillouin optical scanning system (Intelon Optics) (BOSS)

  • Other
    Pre- and Post-DSAEK Group

    Device: Brillouin optical scanning system (Intelon Optics) (BOSS)

  • Other
    Pre- and Post-DMEK Group

    Device: Brillouin optical scanning system (Intelon Optics) (BOSS)

  • Other
    Healthy Control Group

    Device: Brillouin optical scanning system (Intelon Optics) (BOSS)

Interventions

  • DeviceBrillouin 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.

06

What researchers measure

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

    Time frame: 5 months

07

Study locations

1 site
  • VIROS - a Karl Landsteiner Institute
    Vienna, 1140, Austria
08

References and documents

Publications

  • 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. PubMed 39120013 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2025; primary completion for Oct 2025, 6 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 25, 2025
First posted
Apr 6, 2025
StartEst.
Apr 1, 2025
Primary completionEst.
Oct 1, 2025
CompletionEst.
Oct 1, 2025
Last update
Apr 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06914817
Lead sponsor
Vienna Institute for Research in Ocular Surgery
Responsible party
Prim. Prof. Dr. Oliver Findl, MBA (Prim. Prof. Dr., Vienna Institute for Research in Ocular Surgery) — Principal investigator
First posted
Apr 6, 2025
Start date
Apr 1, 2025 (estimated)
Primary completion
Oct 1, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Apr 6, 2025

Study contacts

Daria Amon, MD
Contact
daria.lilian@gmx.at
+436769576114

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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