Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06914817

Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Map Dot Fingerprint Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal dystrophy, epithelial basement membrane Eye Diseases Eye Diseases, Hereditary Fuchs Endothelial Dystrophy Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn Healthy Corneas Ost-Descemet Stripping Automated Endothelial Keratoplasty Post-Descemet Membrane Endothelial Keratoplasty Post-penetrating Keratoplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Brillouin optical scanning system (Intelon Optics) (BOSS)

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.

Primary outcomes

  1. Brillouin shifts

    Time frame: 5 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Daria Amon, MD

CONTACT

[email protected]

+436769576114

Sponsors and collaborators

Lead sponsor

Vienna Institute for Research in Ocular Surgery

Other

Registry information

Official study title

Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties in Patients With Corneal Dystrophies and Post-Corneal Surgery: a Pilot Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.