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

Title: Two-Year Visual, Refractive, and Anatomical Outcomes of Sutureless, Intrascleral, 1-Piece Intraocular Lens Fixation
Authors: Marolo P.; Parisi G.; Conte F.; Cimorosi F.; Tibaldi D.; Fallico M.; Toro M. D.; Borrelli E.; Motta L.; Vaiano A. S.; Reibaldi M.
Contributors: Marolo, P.; Parisi, G.; Conte, F.; Cimorosi, F.; Tibaldi, D.; Fallico, M.; Toro, M. D.; Borrelli, E.; Motta, L.; Vaiano, A. S.; Reibaldi, M.
Publisher Information: ELSEVIER INC
Publication Year: 2026
Collection: Padua Research Archive (IRIS - Università degli Studi di Padova)
Subject Terms: Aphakia; Intraocular len; Refractive outcome; Scleral fixation; Vitrectomy
Description: 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. ...
Document Type: article in journal/newspaper
Language: English
Relation: info:eu-repo/semantics/altIdentifier/pmid/40976573; info:eu-repo/semantics/altIdentifier/wos/WOS:001709692200001; volume:10; issue:3; firstpage:335; lastpage:343; numberofpages:9; journal:OPHTHALMOLOGY RETINA; https://hdl.handle.net/11577/3588640
DOI: 10.1016/j.oret.2025.09.005
Availability: https://hdl.handle.net/11577/3588640; https://doi.org/10.1016/j.oret.2025.09.005
Accession Number: edsbas.C6FBF294
Database: BASE