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Recruiting NCT07294716

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

No phase Interventional Irregular Astigmatism Astigmatism Cataract and IOL Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AMILens Individual.
Who it may be relevant to
Registry conditions: Irregular Astigmatism, Astigmatism, Cataract and IOL Surgery. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change of Astigmatism [Time frame: 4-8 weeks post-surgery]
Secondary outcome measures (4)
  • Agreement of measured variables for astigmatism across devices [Time frame: 4-8 weeks post cataract surgery]
  • Change of higher order optical aberrations (HOAs) [Time frame: 4-8 weeks post cataract surgery]
  • Surgically induced corneal astigmatism (SIA) [Time frame: From enrollment to the end last study visit (4-8 weeks post surgery)]
  • Postoperative uncorrected and best-corrected distance visual acuity [Time frame: 4-8 weeks post cataract surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Kepler University Clinic, Department for Ophthalmology and Optometry — Linz

Identifiers

NCT: NCT07294716 · KUK-Ophthalmology-017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗