CataractNCT06595693
Tilt Prediction of Clareon Intraocular Lens
An observational study of Cataract, run by Johannes Kepler University of Linz at 1 site in Austria.
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
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.
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)
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
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
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.
- First posted19 Sep 2024
- Study start23 May 2023
- Primary completion1 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nino Hirnschall, MD, Principal investigator, JKU Linz
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 42060070Waser 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement and Prediction of Tilt and Decentration of the Clareon Intraocular Lens and Evaluation of It's Effect of Visual Acuity
- ClinicalTrials.gov ID
- NCT06595693
- Acronym / sponsor ID
- JKU-Ophthalmology-001
- Conditions
- Cataract
- Keywords
- Intraocular Lens, tilt, cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 23 May 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 19 Sep 2024 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with planned cataract surgery of both eyes
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
post operative intraocular lens tilt in degrees measured between three different OCT based devices
Time frame: 8 weeks post cataract surgery
amount of tilt of intraocular lens post cataract surgery
3 secondary outcomes
orientation of post operative tilt in degrees measured between three different OCT based devices
Time frame: 8 weeks post cataract surgery
decentration of intraocular lens in millimeter measured between three different OCT based devices
Time frame: 8 weeks post cataract surgery
distance corrected visual acuity in logMAR
Time frame: 8 weeks post cataract surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42060070Waser 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.
- Derived from this study: PubMed 39666249Waser 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.
- Individual participant dataSharing planned: No
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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.
Nino Hirnschall, MD principal investigator
JKU Linz
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 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.