Two-Year Visual, Refractive, and Anatomical Outcomes of Sutureless Intrascleral One-Piece IOL Fixation: A Prospective Study.

Abstract

Purpose: To evaluate the two-year visual, refractive, and anatomical outcomes of a foldable single-piece intraocular lens (IOL) specifically designed for sutureless intrascleral fixation in eyes without adequate capsular support.

Design: Prospective, observational, multicenter study.

Participants: Two hundred thirty-four eyes of 232 patients undergoing secondary IOL implantation using a standardized sutureless intrascleral fixation technique.

Methods: All eyes received a foldable, one-piece acrylic IOL implanted via a scleral flap technique. Best-corrected visual acuity (BCVA), spherical equivalent (SE), refractive prediction error (PE), and endothelial cell density (ECD) were assessed at baseline, 12 months, and 24 months. A subgroup analysis using anterior segment OCT evaluated IOL tilt, decentration, and surgically induced astigmatism (SIA), Multivariate regression explored biometric predictors of refractive outcomes.

Main outcome measures: Changes in BCVA, refractive stability, PE, IOL tilt and decentration, ECD, and postoperative complications.

Results: Mean BCVA improved from 0.74 ± 0.30 to 0.26 ± 0.24 logMAR at 24 months (p < 0.001). SE changed from 3.52 ± 5.92 D at baseline to -0.33 ± 0.85 D at 24 months (p<0.001). A PE within ±1.00 D was achieved in 77% of eyes. Mean absolute SIA remained stable (0.86 ± 0.44 D at 12 months vs 0.90 ± 0.62 D at 24 months; p = 0.911). IOL tilt and decentration showed no significant change over time. ECD was preserved (p = 0.895). Visual decline occurred in 2.56% of eyes and no cases of IOL dislocation or endophthalmitis were observed.

Conclusions: Sutureless intrascleral fixation of a single-piece foldable IOL may lead to sustained visual improvement, high refractive accuracy, stable anatomical positioning, and a low rate of complications over 24 months. This technique demonstrates good tolerability and is associated with favorable visual outcomes for secondary implantation in eyes lacking capsular support.