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NCT Number: NCT07294716

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

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.

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Key information

Conditions

Irregular Astigmatism Astigmatism Cataract Cataract and IOL Surgery Eye Diseases Lens Diseases Refractive Errors

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kepler University Clinic, Department for Ophthalmology and Optometry

Linz, 4020, Austria

Location status: Recruiting

Location contact

Nino Hirnschall, MD, PhD, FEBO, MhBA

CONTACT

[email protected]

+43 (0)5 7680 83 73411

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMILens Individual

Device

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.

Primary outcomes

  1. Change of Astigmatism

    Time frame: 4-8 weeks post-surgery

    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.

Secondary outcomes

  1. Agreement of measured variables for astigmatism across devices

    Time frame: 4-8 weeks post cataract surgery

    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.

  2. Change of higher order optical aberrations (HOAs)

    Time frame: 4-8 weeks post cataract surgery

    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.

  3. Surgically induced corneal astigmatism (SIA)

    Time frame: From enrollment to the end last study visit (4-8 weeks post surgery)

    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

  4. Postoperative uncorrected and best-corrected distance visual acuity

    Time frame: 4-8 weeks post cataract surgery

    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.

Sponsors and collaborators

Lead sponsor

Johannes Kepler University of Linz

Other

Registry information

Official study title

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

Acronym: VITAL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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