Preliminary Rotational Stability And Clinical Performance Of A Biaspheric Edof Toric Intraocular Lens

To preliminarily evaluate rotational misalignment and early clinical outcomes of an extended depth-of-focus (EDOF) toric intraocular lens (IOL), with particular emphasis on the comparison between clinical and anterior segment OCT-based rotational assessment.

A private ophthalmology center in Madrid, Spain (Miranza Group: Instituto de Microcirugía Ocular). All procedures were performed by experienced cataract surgeons using standardized biometric, calculation, and surgical protocols.

This observational post-marketing preliminary analysis included 20 eyes of 10 patients, of which 17 eyes were implanted with a toric EDOF IOL and were eligible for rotational analysis. Rotational misalignment was calculated as the absolute minimal angular difference between intended and observed IOL axis. Rotation was assessed using two independent methodologies: slit-lamp retroillumination imaging (clinical assessment) and anterior segment optical coherence tomography (AS-OCT) at 3 months. Rotational data were described using median and interquartile range (IQR). Visual acuity outcomes (logMAR) and binocular defocus curve were descriptively evaluated.

Among the 17 toric IOLs, median rotational misalignment was 1.5° (IQR 0.0–5.0°) when assessed clinically and 2.0° (IQR 1.0–3.5°) when assessed using AS-OCT. Comparison between assessment methods showed similar magnitudes of rotation, with OCT-based measurements tending to yield slightly lower median values than clinical assessment.

Median monocular uncorrected and corrected distance visual acuity (UDVA and CVDA) at 3 months was -0.01  (IQR -0.04–0.04), and  -0.01 (IQR -0.04–0.00) respectively.  Binocular defocus curve demonstrated a functional EDOF, with median visual acuity  ≤0.2 logMAR across a defocus range from +1.00 to -2.25. No adverse events related to IOL positioning were recorded.

In this preliminary cohort, the EDOF toric IOL demonstrated good rotational stability, with consistent results obtained using both clinical slit-lamp assessment and anterior segment OCT. The close agreement between methodologies supports the reliability of rotational measurements and confirms appropriate IOL positioning. Although limited by sample size and descriptive design, these findings suggest favorable early rotational and clinical performance and warrant confirmation in a larger population with complete follow-up.