Map Dot Fingerprint DystrophyNCT06914817
Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties
A study testing Brillouin optical scanning system (Intelon Optics) (BOSS) in people with Map Dot Fingerprint Dystrophy and Post-penetrating Keratoplasty, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Map Dot Fingerprint Dystrophy, Post-penetrating Keratoplasty, Post-Descemet Membrane Endothelial Keratoplasty
- What is being tested?
- Brillouin optical scanning system (Intelon Optics) (BOSS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
VIROS - a Karl Landsteiner Institute
Vienna, Austria, 1140
Oliver Findl, Prof. MD. MBA, 01 9102157564, office@viros.at
About this study
Official title: Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties in Patients With Corneal Dystrophies and Post-Corneal Surgery: a Pilot Study
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.
Read more
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.
- Conditions
- Map Dot Fingerprint Dystrophy, Post-penetrating Keratoplasty, Post-Descemet Membrane Endothelial Keratoplasty, Healthy Corneas, Fuchs Endothelial Dystrophy, Ost-Descemet Stripping Automated Endothelial Keratoplasty
- Being tested
- Brillouin optical scanning system (Intelon Optics) (BOSS)
- Medical subject headings
- Corneal dystrophy, epithelial basement membrane, Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Fuchs' Endothelial Dystrophy (FED) Group | Other | Not described Receives: Device: Brillouin optical scanning system (Intelon Optics) (BOSS) |
| Map Dot Fingerprint Dystrophy (MDFD) Group | Other | Not described Receives: Device: Brillouin optical scanning system (Intelon Optics) (BOSS) |
| Post-Penetrating Keratoplasty (PKP) Group | Other | Not described Receives: Device: Brillouin optical scanning system (Intelon Optics) (BOSS) |
| Post-DSAEK Group | Other | Not described Receives: Device: Brillouin optical scanning system (Intelon Optics) (BOSS) |
| Post-DMEK Group | Other | Not described Receives: Device: Brillouin optical scanning system (Intelon Optics) (BOSS) |
| Pre- and Post-DSAEK Group | Other | Not described Receives: Device: Brillouin optical scanning system (Intelon Optics) (BOSS) |
| Pre- and Post-DMEK Group | Other | Not described Receives: Device: Brillouin optical scanning system (Intelon Optics) (BOSS) |
| Healthy Control Group | Other | Not described Receives: Device: Brillouin optical scanning system (Intelon Optics) (BOSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Map Dot Fingerprint DystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914817
- Sponsor's protocol ID
- BMC
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brillouin Microscopy Used to Evaluate Corneal Mechanical Properties in Patients With Corneal Dystrophies and Post-Corneal Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT06914817
- Acronym / sponsor ID
- BMC
- Conditions
- Map Dot Fingerprint Dystrophy, Post-penetrating Keratoplasty, Post-Descemet Membrane Endothelial Keratoplasty, Healthy Corneas, Fuchs Endothelial Dystrophy, Ost-Descemet Stripping Automated Endothelial Keratoplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Healthy Controls: healthy eyes without any history of corneal diseases or surgeries
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brillouin 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. | Device | Fuchs' Endothelial Dystrophy (FED) Group, Healthy Control Group, Map Dot Fingerprint Dystrophy (MDFD) Group, Post-DMEK Group, Post-DSAEK Group, Post-Penetrating Keratoplasty (PKP) Group, Pre- and Post-DMEK Group, Pre- and Post-DSAEK Group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Results publication: PubMed 39120013Vinciguerra 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.
- Individual participant dataSharing planned: No
Related trials for Map Dot Fingerprint Dystrophy
Not yet recruiting
Manual Debridement vs Phototherapeutic Keratectomy in the Treatment of Corneal Basement Membrane Dystrophy
Epithelial Basement Membrane Dystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brillouin optical scanning system (Intelon Optics) (BOSS) in people with Map Dot Fingerprint Dystrophy and Post-penetrating Keratoplasty, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daria Amon, MD (+436769576114, daria.lilian@gmx.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brillouin shifts (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06914817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.