CataractNCT07425626
Brillouin Scanning in Cataractous Eyes
An observational study of Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.
Trial summary
To provide first results for biomechanical properties of cataractous lenses via Brillouin microscopy and correlations between LOCS III grading, cataractous lens scans from optical coherence tomography (OCT), and intraoperative phacoemulsification energy. Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- Brillouin-Microscopy
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 11 Mar 2025to 1 Jun 2026
- Phase
- Observational
- 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 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 cataract patients with predominantly nuclear cataract
Who may be able to join
- Men and women aged above 21 years
- Normal ophthalmic findings except previous surgery or conditions that impact corneal optical quality such as trauma and corneal scars
- Willing to sign informed consent before measurements
- Presence of nuclear cataract according to LOCS III grading and planned cataract surgery
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 active ocular infections or inflammatory conditions
- Patients that suffered an eye trauma according to their medical history
- Patients with fixational problems (e.g., nystagmus) 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.
Austria1 site
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Vienna, 1140
About this study
Official title: Pilot Evaluation of Cataractous Lens Stiffening Using a Brillouin Scanning Device
To provide first results for biomechanical properties of cataractous lenses via Brillouin microscopy and correlations between LOCS III grading, cataractous lens scans from optical coherence tomography (OCT), and intraoperative phacoemulsification energy.
Read the detailed description
Brillouin microscopy (BM), based on Brillouin light scattering theory, has become established in clinical ophthalmology for examining retinal properties, corneal diseases, and age-related lens changes. These BM-derived metrics can portray the intrinsic characteristics of the biosystem, such as the hydration state or the content and anisotropy of corneal collagen fibers, while remaining unaffected by factors such as intraocular pressure and central corneal thickness. In vivo, BM has been shown to characterize the depth-dependent or gradient viscoelastic properties of ocular lenses. Some studies have used this technique to show that the lens nucleus thickens with age, while the thickness of the lens cortex remains constant. Laboratory studies have also shown an increase in the stiffness of the lens nucleus, while later clinical Brillouin measurement studies have shown that the nucleus is clearly distinct from the softer cortex.
Although data on age-related lenticular changes already exist, the in vivo lenticular biomechanics of cataract lenses derived from Brillouin still need to be comprehensively investigated. This is relevant in that the correlation of Brillouin-derived cataract lens mechanics with the Lens Opacity Classification System (LOCS III) and/or the phacoemulsification energy required for cataract surgery may provide useful information about whether the technique could provide valuable insights into lens nuclear stiffening. Very hard or soft nuclei remain one of the major risk factors for the complications occuring during cataract surgery. In the former case, a significantly higher amount of energy is required during phacoemulsification, which can lead to simultaneous damage to the corneal endothelium and prolonged surgical recovery. In the latter case, intraoperative fragmentation of the cell nucleus poses a challenge.
Currently, the type, degree, and (representative) hardness of the cataract lens are assessed preoperatively using a slit lamp examination with the LOCS III system. The degree of lens opacity provides information about how phacoemulsification should be performed, which viscoelastic device should be selected, and what experience the surgeon needs to perform the operation. However, the slit lamp assessment method is susceptible to subjective variability between observers. Given the unique characteristics of assessing the biomechanical properties of the lens in vivo and the short scan time, BM could be used as a novel complementary objective method for surgical decision-making.
- Conditions
- Cataract
- Being tested
- Brillouin-Microscopy
- Keywords
- Cataract, Brillouin-Microscopy, Lens Stiffening
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brillouin-MicroscopyDevice
A Brillouin scattering microscopy system (Brillouin Optical Scanning System, Intelon Optics, Boston, MA) will be employed to acquire data. The emission spectrum of the single-frequency tunable laser is fixed at approximately 780 nm near-infrared wavelength. Polarization optics direct the laser beam to the eye and channel backscattered light to a single-mode fiber at the human interface, where the laser light is transmitted over a polarization-maintaining single-mode fiber. To achieve a free-spectral range (FSR) of approximately 16 GHz, a resolution of approximately 0.3 GHz, and an extinction efficiency of -65 dB, the spectrometer employs dual-stage VIPA (virtually imaged phase arrays) etalons. The cornea's optical power is 3-5 mW, which is significantly lower than the utmost permissible exposure level as defined by the American National Standards Institute (ANSI).
| Study group | Role | What they receive |
|---|---|---|
| Cataract Patients | 50 Patients with Cataract Receives: Device: Brillouin-Microscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brillouin shift/stiffness metrics
Correlation between Brillouin shift/stiffness metrics and LOCS III grading, OCT lens opacification scans/metrics and and intraoperative phacoemulsification energy
Measured: 24 months
Secondary outcomes (1)
Repeatability of Brillouin-Microscopy Measurements
Repeatability as within subject standard deviation, test-retest repeatability, and intraclass-correlation coefficients from BM in cataractous eyes
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start11 Mar 2025
- Primary completion1 Feb 2026
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, Prof., Dr., Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425626
- Sponsor's protocol ID
- Brillouin Cataract
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of Cataractous Lens Stiffening Using a Brillouin Scanning Device
- ClinicalTrials.gov ID
- NCT07425626
- Acronym / sponsor ID
- Brillouin Cataract
- Conditions
- Cataract
- Keywords
- Cataract, Brillouin-Microscopy, Lens Stiffening
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Prim. Prof. Dr. Oliver Findl, MBAUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 23 Feb 2026 (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.
To provide first results for biomechanical properties of cataractous lenses via Brillouin microscopy and correlations between LOCS III grading, cataractous lens scans from optical coherence tomography (OCT), and intraoperative phacoemulsification energy.
Detailed description
Brillouin microscopy (BM), based on Brillouin light scattering theory, has become established in clinical ophthalmology for examining retinal properties, corneal diseases, and age-related lens changes. These BM-derived metrics can portray the intrinsic characteristics of the biosystem, such as the hydration state or the content and anisotropy of corneal collagen fibers, while remaining unaffected by factors such as intraocular pressure and central corneal thickness. In vivo, BM has been shown to characterize the depth-dependent or gradient viscoelastic properties of ocular lenses. Some studies have used this technique to show that the lens nucleus thickens with age, while the thickness of the lens cortex remains constant. Laboratory studies have also shown an increase in the stiffness of the lens nucleus, while later clinical Brillouin measurement studies have shown that the nucleus is clearly distinct from the softer cortex.
Although data on age-related lenticular changes already exist, the in vivo lenticular biomechanics of cataract lenses derived from Brillouin still need to be comprehensively investigated. This is relevant in that the correlation of Brillouin-derived cataract lens mechanics with the Lens Opacity Classification System (LOCS III) and/or the phacoemulsification energy required for cataract surgery may provide useful information about whether the technique could provide valuable insights into lens nuclear stiffening. Very hard or soft nuclei remain one of the major risk factors for the complications occuring during cataract surgery. In the former case, a significantly higher amount of energy is required during phacoemulsification, which can lead to simultaneous damage to the corneal endothelium and prolonged surgical recovery. In the latter case, intraoperative fragmentation of the cell nucleus poses a challenge.
Currently, the type, degree, and (representative) hardness of the cataract lens are assessed preoperatively using a slit lamp examination with the LOCS III system. The degree of lens opacity provides information about how phacoemulsification should be performed, which viscoelastic device should be selected, and what experience the surgeon needs to perform the operation. However, the slit lamp assessment method is susceptible to subjective variability between observers. Given the unique characteristics of assessing the biomechanical properties of the lens in vivo and the short scan time, BM could be used as a novel complementary objective method for surgical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cataract Patients | – | Device: Brillouin-Microscopy50 Patients with Cataract |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 cataract patients with predominantly nuclear cataract
Key inclusion criteria (4 listed)
- Men and women aged above 21 years
- Normal ophthalmic findings except previous surgery or conditions that impact corneal optical quality such as trauma and corneal scars
- Willing to sign informed consent before measurements
- Presence of nuclear cataract according to LOCS III grading and planned cataract surgery
Key exclusion criteria (6 listed)
- Patients with inadequate corneal imaging or corneal scarring that would impact results
- Patients with active ocular infections or inflammatory conditions
- Patients that suffered an eye trauma according to their medical history
- Patients with fixational problems (e.g., nystagmus) or with any medical condition that could interfere with the measurements
- Pregnancy (pregnancy test will be performed in women of reproductive age)
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-MicroscopyA Brillouin scattering microscopy system (Brillouin Optical Scanning System, Intelon Optics, Boston, MA) will be employed to acquire data. The emission spectrum of the single-frequency tunable laser is fixed at approximately 780 nm near-infrared wavelength. Polarization optics direct the laser beam to the eye and channel backscattered light to a single-mode fiber at the human interface, where the laser light is transmitted over a polarization-maintaining single-mode fiber. To achieve a free-spectral range (FSR) of approximately 16 GHz, a resolution of approximately 0.3 GHz, and an extinction efficiency of -65 dB, the spectrometer employs dual-stage VIPA (virtually imaged phase arrays) etalons. The cornea's optical power is 3-5 mW, which is significantly lower than the utmost permissible exposure level as defined by the American National Standards Institute (ANSI). | Device | Cataract Patients |
Primary outcome
Brillouin shift/stiffness metrics
Time frame: 24 months
Correlation between Brillouin shift/stiffness metrics and LOCS III grading, OCT lens opacification scans/metrics and and intraoperative phacoemulsification energy
1 secondary outcome
Repeatability of Brillouin-Microscopy Measurements
Time frame: 24 months
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 23 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Oliver Findl, Prof., Dr. principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brillouin shift/stiffness metrics (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2026.