Predicting Intraocular Lens Tilt Using OCT Measurements and Partial Least Squares Regression Modelling

NCT06305338 | Completed

• 1 other identifier: KUK-Ophthalmology-009
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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 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. 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. 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

Intraocular Lens; Cataract

Keywords

Tilt

Outcome Measures

Primary Outcomes (1)

• post operative IOL tilt

  Predicting the post-operative tilt using PLS regression

  8 weeks post cataract surgery

Secondary Outcomes (3)

• Comparison of tilt prediction

  8 weeks post cataract surgery

• comparion of three measurement methods

  8 weeks post cataract surgery

• Comparison of tilt pre- versus post operative

  pre operative at screening and 8 weeks post cataract operation

Interventions

Optical Coherence Tomography OTHER

the study releated measurements will be performed: IOLMaster 700, Casia 2 and Pentacam HR.

Also known as: biometry (IOL Master700), Casia2, Pentacam HR

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who undergo planned cataract surgeries above 21 years

You may qualify if:

• Planned cataract surgery in one or both eyes
• Above 21 years of age

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johannes Kepler University of Linz: lead

Study Sites (1)

Matthias Bolz

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Conditions

Cataract

Interventions

Tomography, Optical Coherence; Biometry

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Statistics as Topic; Epidemiologic Methods; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Nino Hirnschall, MD

  JKU Linz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 12, 2024
• Study Start: April 12, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 26, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)