Improving Visual Quality in Patients With Irregular Corneas Using Asymmetrical Toric Intraocular Lenses (VITAL)

VITAL - "Visual Improvement With Toric Asymmetrical Lenses": Enhancing Vision in Irregular Corneas

Cataract surgery in patients with irregular corneas presents unique challenges, primarily due to the high variability in keratometry and corneal tomography measurements, which complicates accurate intraocular lens (IOL) calculations. In these patients, therapeutic options are currently limited to either non-toric IOLs and rigid contact lenses postoperatively or conventional toric IOLs for the reduction of total astigmatism within cataract surgery. While conventional toric IOLs may be beneficial in selected cases with a stable astigmatic pattern and clear axis, their effectiveness is largely limited, as significant irregularity and higher order aberrations reduce predictability, accuracy of formulae, and refractive outcomes. Therefore, the development of a reliable method to reduce total astigmatism - including irregular components - would represent a major advancement, potentially improving both visual function and patient quality of life. The aim of this exploratory study is to evaluate the effectiveness of customized toric intraocular lenses (AMILens Individual, AMIPLANT GmbH, Germany) in reducing total corneal astigmatism in patients with a significant irregular astigmatic component. These lenses are designed to address corneal aberrations up to the 6th Zernike order, thereby extending correction beyond the capabilities of conventional toric IOLs. To our knowledge, no clinical study has yet investigated this novel approach.

Study Overview

• Status: Recruiting
• Conditions: Astigmatism; Irregular Astigmatism; Cataract and IOL Surgery
• Intervention / Treatment: Device: AMILens Individual

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4020
    • Recruiting
    • Kepler University Clinic, Department for Ophthalmology and Optometry
    • Contact: Nino Hirnschall, MD, PhD, FEBO, MhBA; Phone Number: +43 (0)5 7680 83 73411; Email: nino.hirnschall@kepleruniklinikum.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 21 years or older
• Scheduled cataract surgery
• At least 1.75 D of total astigmatism in the CASIA2 measurement
• At least 0.75 D of asymmetry or higher order irregularity within the 6mm zone of the real (total) index corneal refractive map of the CASIA2 measurements

Exclusion Criteria:

• Relevant central corneal scars
• PEX, previous ocular surgery, severe trauma or any pathology that could lead to an unstable capsular bag
• Combined surgery (cataract plus glaucoma/vitreoretinal/corneal surgery)
• Postoperative best corrected distance visual acuity below 0.3 Snellen decimal
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AMILens Individual Implantation; An acrylic hydrophilic, one piece 4-loop haptic, monofocal, toric IOL (AMILens Individual, AMIPLANT GmbH, Germany) will be implanted into the capsular bag after removal of the of the natural lens. This IOL is CE-certified. Asphericity and dioptric power of the IOL are customized for each individual eye.	Device: AMILens Individual; An acrylic hydrophilic, one piece 4-loop haptic, monofocal, toric IOL (AMILens Individual, AMIPLANT GmbH, Germany) will be implanted into the capsular bag after removal of the of the natural lens. This IOL is CE-certified. Asphericity and dioptric power of the IOL are customized for each individual eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Astigmatism	The change of astigmatism is defined by the difference of the postoperative total refractive/ocular astigmatism (assessed via subjective refraction) to the preoperative corneal astigmatism (assessed via the utilized measurement devices). Reduction in total ocular (refractive) astigmatism will be quantified as both absolute reduction (Diopter) and relative reduction (%). Descriptive statistics will include mean, standard deviation, median, interquartile range, and range. Normality will be tested using the Shapiro-Wilk test and Q-Q plots. If normally distributed: comparisons between preoperative and postoperative values will be assessed with a paired t-test. If not normally distributed: the Wilcoxon signed-rank test will be applied. Results will be presented with 95% confidence intervals. As this is an exploratory study, p-values will be reported descriptively, and values below 0.05 will not be interpreted as statistically significant.	4-8 weeks post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement of measured variables for astigmatism across devices	The agreement of the variables anterior corneal astigmatism, posterior corneal astigmatism, total corneal astigmatism, Zernike Polynomials first to seventh order, lower order aberrations (LOAs), and higher order aberrations (HOAs) are compared across the utilized measurement devices Pentacam, Anterion, ms39, and CASIA2. All mentioned variables are on a ratio scale. Agreement between different devices will be assessed using: Bland-Altman analysis (mean difference and 95% limits of agreement),Intraclass correlation coefficients (ICCs) for reliability, and, where appropriate, repeated-measures ANOVA or Friedman test (non-parametric) across multiple modalities.	4-8 weeks post cataract surgery
Change of higher order optical aberrations (HOAs)	Higher order optical abberation values are measured posoperatively for the whole eye (cornea and lens) with the osiris device, and compared to the preoperative corneal higher order abberations, which are measured with the Casia2 and the ms39 devices. Reduction in higher order aberrations will be quantified as both absolute reduction (D) and relative reduction (%). The same descriptive statistics, normality testing, and comparison testing as described above will be applied. Results will be presented with 95% confidence intervals and p-values will be reported descriptively.	4-8 weeks post cataract surgery
Surgically induced corneal astigmatism (SIA)	Surgically induced corneal astigmatism (SIA) will be evaluated by calculating the vectorial changes of corneal astigmatism (magnitude ind diopter and axis in degree) between preoperative and postoperative corneal astigmatism measurements for each measurement device	From enrollment to the end last study visit (4-8 weeks post surgery)
Postoperative uncorrected and best-corrected distance visual acuity	These values are assessed via standardized subjective refraction using the jackson cross cylinder method, and will be described descriptively in logMAR unit. Postoperative uncorrected and best-corrected visual acuity will be analyzed as both continuous variables and using threshold-based categories. Descriptive statistics will include mean, standard deviation, median, interquartile range, and range.	4-8 weeks post cataract surgery

Collaborators and Investigators

• Sponsor: Johannes Kepler University of Linz

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Lens Diseases; Cataract; Astigmatism
• Other Study ID Numbers: KUK-Ophthalmology-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual data will not be made available to other researchers. Only the results will be shared in peer-reviewed journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No