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 overtime. 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. Ophthalmology Retina 2026;10:335-343 (c) 2025 by the American Academy of Ophthalmology Supplemental material available at www.ophthalmologyretina.org.
Two-Year Visual, Refractive, and Anatomical Outcomes of Sutureless, Intrascleral, 1-Piece Intraocular Lens Fixation
Motta L.;
2026
Abstract
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 overtime. 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. Ophthalmology Retina 2026;10:335-343 (c) 2025 by the American Academy of Ophthalmology Supplemental material available at www.ophthalmologyretina.org.
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