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CataractNCT06595693

Tilt Prediction of Clareon Intraocular Lens

An observational study of Cataract, run by Johannes Kepler University of Linz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Misalignment of intraocular lenses can cause severe loss of visual quality. Different types of misalignments are known. Tilt, one type of intraocular lens misalignment is thought to play a negative role for the optical performance in eyes with intraocular designs, especially, if they have aspheric, toric, or… Read more about this study

Who is it for?
Any age
Conditions the study is for
Cataract
How many people
52 participants
Where
1 siteAustria
Study dates
23 May 2023to 29 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: patients with planned cataract surgery of both eyes

Who may be able to join

  • Planned cataract surgery in both eyes (bilateral inclusion only)
  • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
  • Ability to consent to the participation in the study;
  • Signed informed consent

Who cannot join

  • Combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery)
  • Best corrected distance visual acuity below 0.1 Snellen before surgery
  • Pathologies that could have an influence on the post-operative tilt, such as pseudoexfoliation syndrome or previous ophthalmic trauma, or other reasons for phakodonesis
  • Previous ophthalmic surgery that could have an influence on post-operative tilt, such as pars plana vitrectomy
  • Pregnancy (pregnancy test will be taken preoperatively)

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria

    Linz, Upper Austria, 4020

Other trials in Austria

About this study

Official title: Measurement and Prediction of Tilt and Decentration of the Clareon Intraocular Lens and Evaluation of It's Effect of Visual Acuity

Misalignment of intraocular lenses can cause severe loss of visual quality. Different types of misalignments are known. Tilt, one type of intraocular lens misalignment is thought to play a negative role for the optical performance in eyes with intraocular designs, especially, if they have aspheric, toric, or multifocal optics. Various methods to measure intraocular lens misalignments have been described. The most recently developed method for tilt quantification is the use of optical coherence tomography. This method has several advantages compared to the previous methods: optical coherence tomography based devices are available in most clinics, the resolution of modern optical coherence tomography devices is high, and the measurements are reproducible.

Read the detailed description

During cataract surgery an artificial intraocular lens is implanted in the eye to replace the lens and to correct the refraction for distance vision. Misalignment of intraocular lenses can cause severe loss of visual quality. Different types of misalignments are known. Tilt, one type of intraocular lens misalignment is thought to play a negative role for the optical performance in eyes with intraocular lens designs, especially, if they have aspheric, toric, or multifocal optics. For example, in the case of aspheric intraocular lenses, it appears that even slight amount of tilt may result not only in the loss of the effect of reducing spherical aberrations but in more severe cases even a worsening of the optical quality compared to spherical intraocular lenses. In the case of toric intraocular lenses, tilt introduces higher order aberrations potentially mimicking astigmatism. In the case of multifocal intraocular lenses, tilt increases higher order aberrations, which leads to decreased visual quality.

Various methods to measure intraocular lens misalignments have been described. Studies assessing the intraocular lens position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera to assess intraocular lens decentration and tilt. The subjective grading at the slitlamp may display considerable variability between examiners. This method is more qualitative than quantitative and does not allow fine resolution when reporting intraocular lens tilt. The fact that the patient has no standardized target to focus on makes the method even less reliable. Scanning methods such as Scheimpflug photos require a very well dilated pupil exceeding 6mm to assess the intraocular lens position. Additionally, it can be difficult to identify the anatomical structures of the eye that need to be used as points of reference. Scheimpflug camera images have been used for assessing intraocular lens tilt previously, but erroneous results, often due to corneal magnification, have diminished their widespread use. Another possibility to assess tilt is the use of Purkinje reflexes. The light reflections of Purkinje images at ocular surfaces to evaluate ocular alignment have recently been utilized. Since light is reflected at all interfaces of media with a difference in refractive index, these reflections, called Purkinje images, can be used to assess tilt and decentration of intraocular lenses. Two different clinically applicable Purkinjemeter system provide the measurement of intraocular decentration and tilt. The main problem with Purkinje meters is accessibility, as there are only a few prototypes available worldwide.

The most recently developed method for tilt quantification is the use of optical coherence tomography. This method has several advantages compared to the previous methods: optical coherence tomography based devices are available in most clinics, the resolution of modern optical coherence tomography devices is high, and the measurements are reproducible.

Conditions
Cataract
Keywords
Intraocular Lens, tilt, cataract
Medical subject headings
Cataract

What is being measured

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

  1. post operative intraocular lens tilt in degrees measured between three different OCT based devices

    amount of tilt of intraocular lens post cataract surgery

    Measured: 8 weeks post cataract surgery

Secondary outcomes (3)
  1. orientation of post operative tilt in degrees measured between three different OCT based devices

    Orientation of post operative tilt in degrees measured with three different optical coherence tomography devices.

    Measured: 8 weeks post cataract surgery

  2. decentration of intraocular lens in millimeter measured between three different OCT based devices

    Decentration of intraocular lens in millimeter is being determined with three different optical coherence tomography devices and compared to a Scheimpflug camera.

    Measured: 8 weeks post cataract surgery

  3. distance corrected visual acuity in logMAR

    Distance corrected visual acuity in logMAR will be determined by Best Corrected Visual Acuity

    Measured: 8 weeks post cataract surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start23 May 2023
  3. Primary completion1 Apr 2024
  4. Study completion29 Apr 2024

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
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06595693
Sponsor's protocol ID
JKU-Ophthalmology-001
Status last verified
Sep 2024
First submitted
29 Aug 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Waser K, Strassmair K, Khalil H, Pomberger L, Reifeltshammer SA, Bolz M, Hirnschall N. Predicting Postoperative Anterior Chamber Depth, Intraocular Lens Tilt, and Decentration Using an Internally Validated Machine Learning Model. Ophthalmol Ther. 2026 Jun;15(6):2003-2016. doi: 10.1007/s40123-026-01387-0. Epub 2026 Apr 30.

    PubMed 42060070
  • Waser K, Strassmair K, Pomberger L, Khalil H, Laubichler P, Bolz M, Hirnschall N. Capsular Bag Performance of a Novel Hydrophobic Single-Piece Intraocular Lens. Ophthalmol Ther. 2025 Feb;14(2):295-308. doi: 10.1007/s40123-024-01075-x. Epub 2024 Dec 12.

    PubMed 39666249

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract, run by Johannes Kepler University of Linz 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 5 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

post operative intraocular lens tilt in degrees measured between three different OCT based devices (time frame: 8 weeks post cataract surgery). 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 NCT06595693, which also lists 2 linked publications.

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 19 Sep 2024.

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