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.

NCT Number	NCT07294716
Lead Sponsor	Johannes Kepler University of Linz
Conditions	Irregular Astigmatism, Astigmatism, Cataract and IOL Surgery
Enrollment	15 participants
Start Date	2026-01-20
Primary Completion	2027-01 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-01-26