NCT06914817

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 25, 2025

Last Update Submit

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

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

Map Dot Fingerprint Dystrophy (MDFD) Group

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

Post-Penetrating Keratoplasty (PKP) Group

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

Post-DSAEK Group

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

Post-DMEK Group

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

Pre- and Post-DSAEK Group

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

Pre- and Post-DMEK Group

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

Healthy Control Group

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

Interventions

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.

Fuchs' Endothelial Dystrophy (FED) GroupHealthy Control GroupMap Dot Fingerprint Dystrophy (MDFD) GroupPost-DMEK GroupPost-DSAEK GroupPost-Penetrating Keratoplasty (PKP) GroupPre- and Post-DMEK GroupPre- and Post-DSAEK Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Corneal dystrophy, epithelial basement membraneFuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

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

Locations