Clinical Validation Of A Novel Digital Intraoperative Guidance System For Accurate Toric Iol Alignment

To evaluate the intraoperative alignment accuracy of a novel digital guidance system for toric intraocular lens (IOL) implantation and to assess1-month postoperative refractive outcomes.

Single-surgeon, single-center private practice cataract surgery facility

Prospective, observational study of 35 consecutive eyes undergoing toric IOL implantation. The digital guidance system (Cassini Technologies, B.V.) calculated and displayed intraoperative alignment axes. Three independent masked reviewers annotated paired pre- and intraoperative images using six anatomical landmarks to determine a reference axis. Eyes with ≥3° inter-reviewer disagreement were excluded. The primary endpoint was absolute difference between displayed and reference axes. Secondary endpoints included time to guidance initiation and 1-month refractive outcomes.

Nineteen eyes met agreement criteria for primary analysis. Mean absolute axis difference was 1.51° ± 1.84° (median 0.59°). Mean time to guidance initiation was 17.6 seconds (n=35). At 1 month follow-up, 13 eyes were available for refractive analysis; mean residual refractive cylinder was 0.31 ± 0.34 D. Mean uncorrected distance visual acuity was 0.15 ± 0.12 logMAR (logarithm of the minimum angle of resolution) and corrected distance visual acuity was 0.05 ± 0.09 logMAR.

The digital guidance system demonstrated strong agreement with an anatomical reference standard for toric IOL axis determination. Postoperative outcomes showed low residual refractive astigmatism and favorable visual acuity, supporting clinically meaningful intraoperative alignment precision.