Two-Year Visual, Refractive, and Anatomical Outcomes of Sutureless, Intrascleral, 1-Piece Intraocular Lens Fixation: A Prospective Study

Purpose To evaluate the 2-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, 1-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). Spherical equivalent changed from 3.52 ± 5.92 diopters (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). Intraocular lens 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. Financial Disclosure(s) Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.