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CataractNCT07425626

Brillouin Scanning in Cataractous Eyes

An observational study of Cataract, run by Prim. Prof. Dr. Oliver Findl, MBA at 1 site in Austria.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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

Other trials in Austria

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 groups in NCT07425626
Study groupRoleWhat they receive
Cataract Patients50 Patients with Cataract
Receives: Device: Brillouin-Microscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted23 Feb 2026
  2. Study start11 Mar 2025
  3. Primary completion1 Feb 2026
  4. Study completion1 Jun 2026 (estimated)

Resources

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)
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

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.

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