Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT07294716

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

Led by Johannes Kepler University of Linz · Updated on 2026-01-26

15

Participants Needed

1

Research Sites

71 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 years or older
  • Scheduled cataract surgery
  • At least 1.75 diopters of total astigmatism measured by CASIA2
  • At least 0.75 diopters of asymmetry or higher order irregularity within the 6mm zone of the total corneal refractive map measured by CASIA2
Not Eligible

You will not qualify if you...

  • Presence of relevant central corneal scars
  • Pseudoexfoliation syndrome (PEX), previous eye surgery, severe trauma, or any condition causing an unstable capsular bag
  • Combined surgery including cataract plus glaucoma, vitreoretinal, or corneal surgery
  • Postoperative best corrected distance visual acuity below 0.3 Snellen decimal
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Kepler University Clinic, Department for Ophthalmology and Optometry

Linz, Austria, 4020

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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