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CompletedNCT06595693Updated Sep 19, 2024

Tilt Prediction of Clareon Intraocular Lens

An observational study in Cataract, sponsored by Johannes Kepler University of Linz. Completed at 1 site in Austria. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Johannes Kepler University of Linz · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
52
Sex
All
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Study 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 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.

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Conditions studied

  • Cataract

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Keywords

  • Intraocular Lens
  • tilt
  • cataract
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 52 is below the median of 81 across 484 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Johannes Kepler University of Linz is the lead sponsor of 32 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with planned cataract surgery of both eyes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
52 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    amount of tilt of intraocular lens post cataract surgery

    Time frame: 8 weeks post cataract surgery

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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

    Time frame: 8 weeks post cataract surgery

Other outcomes

  1. visual acuity in logMAR in a subgroup of eyes

    visual acuity in logMAR in a subgroup of eyes with tilt greater than 5 degrees or less than 5 degrees determined by Best Corrected Visual Acuity

    Time frame: 8 weeks post cataract surgery

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Study locations

1 site
  • Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria
    Linz, Upper Austria 4020, Austria
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06595693
Lead sponsor
Johannes Kepler University of Linz
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
May 23, 2023
Primary completion
Apr 1, 2024
Completion
Apr 29, 2024
Last update
Sep 19, 2024

Study contacts

Nino Hirnschall, MD
principal investigator · JKU Linz

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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