Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties

Vienna Institute for Research in Ocular Surgery

Status: Not yet enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06914817

BMC

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 8 patient groups

Fuchs' Endothelial Dystrophy (FED) Group

Other group

Treatment:

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

Map Dot Fingerprint Dystrophy (MDFD) Group

Other group

Treatment:

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

Post-Penetrating Keratoplasty (PKP) Group

Other group

Treatment:

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

Post-DSAEK Group

Other group

Treatment:

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

Post-DMEK Group

Other group

Treatment:

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

Pre- and Post-DSAEK Group

Other group

Treatment:

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

Pre- and Post-DMEK Group

Other group

Treatment:

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

Healthy Control Group

Other group

Treatment:

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