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AzTrials

CataractTiltNCT05915429

Predicting Lens Tilt Using Optical Coherence Tomography and Partial Least Squares Regression Modelling

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

Who is it for?
Ages 21 years and older
Conditions the study is for
Cataract
How many people
110 participants
Where
1 siteAustria
Study dates
12 Apr 2022to 26 Apr 2023
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 21 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with planned cataract surgery

Who may be able to join

  • planned cataract surgery in one or both eyes
  • above 21 years of age

Who cannot join

  • Combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery)
  • Best corrected distance visual acuity below 0.05 Snellen
  • 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
  • In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Kepler University Hospital

    Linz, Upper Austria, 4021

Other trials in Austria

About this study

Official title: Predicting Post-operative Intraocular Lens Tilt Using Optical Coherence Tomography Measurements and Partial Least Squares Regression Modelling

Misalignment of IOLs can cause severe loss of visual quality. Different types of misalignment are known. Tilt is one type of misalignment that is thought to play a negative role for the optical performance in eyes with IOL designs, especially, if they have aspheric, toric or multifocal optics.

Due to the fact that tilt has an influence on visual quality, the prediction of the post-operative tilt could improve IOL power calculaton significantly especially for toric IOLs. the Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression.

Read the detailed description

During cataract surgery an artificial intraocular lens (IOL) is implanted in the eye to replace the lens and to correct the refraction for distance vision. Misalignment of IOLs can cause severe loss of visual quality. Different types of misalignment are known. Tilt, one type of IOL misalignment is thought to play a negative role for the optical performance in eyes with IOL designs, especially, if they have aspheric, toric, or multifocal optics. For example, in the case of aspheric IOLs, 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 IOLs. In the case of toric IOLs, tilt introduces higher order aberrations potentially mimicking astigmatism. In the case of multifocal IOLs, tilt increases higher order aberrations, which leads to decreased visual quality.

Various methods to measure IOL misalignments have been described. Studies assessing the IOL position have used subjective grading methods at the slit lamp examination or a Scheimpflug camera 2 to assess IOL 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 IOL 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 IOL position. Additionally, it can be difficult to identify the anatomical structures of the eye that need to be used as points of reference. 3 Scheimpflug camera images have been used for assessing IOL 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 IOLs. Two different clinically applicable Purkinjemeter system provide the measurement of IOL 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: OCT based devices are available in most clinics, the resolution of modern OCT devices is high, and the measurements are reproducible.

Due to the fact that tilt has an influence on visual quality, the prediction of the post-operative tilt could improve IOL power calculation significantly, especially for toric IOLs. In the literature, the prediction of tilt was shown to be acceptable for the orientation of tilt, but not for the amount of tilt. Furthermore, there is disagreement concerning the fact, if the amount of tilt increases or decreases after cataract surgery. Aim of this study is to measure tilt with two modern OCT based devices and one Scheimpflug camera and to predict the post-operative tilt using partial least squares regression. This method was developed by Wold and introduced to ophthalmology previously.

Conditions
Cataract
Keywords
IOL, tilt, OCT, Scheimpflug
Medical subject headings
Cataract

What is being measured

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

  1. change of amount of tilt

    difference between preoperative amount of tilt in degrees and postoperative tilt in degrees

    Measured: preoperation visit and 8 weeks postoperation visit

Timeline

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

  1. First posted23 Jun 2023
  2. Study start12 Apr 2022
  3. Primary completion26 Apr 2023
  4. Study completion26 Apr 2023

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
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05915429
Sponsor's protocol ID
KUK-Ophthalmology-004
Acronym
Tilt
Status last verified
Oct 2023
First submitted
5 Oct 2022
Last updated
4 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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 2 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 4 Oct 2023. 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?

change of amount of tilt (time frame: preoperation visit and 8 weeks postoperation visit). 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 4 Oct 2023.

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