Paola Marolo, Guglielmo Parisi, Fabio Conte, Francesca Cimorosi, Davide Tibaldi, Matteo Fallico, Mario Damiano Toro, Enrico Borrelli, Lorenzo Motta, Agostino S Vaiano, Michele Reibaldi
{"title":"一项前瞻性研究：无缝合线巩膜内一体式人工晶状体固定的两年视力、屈光和解剖结果。","authors":"Paola Marolo, Guglielmo Parisi, Fabio Conte, Francesca Cimorosi, Davide Tibaldi, Matteo Fallico, Mario Damiano Toro, Enrico Borrelli, Lorenzo Motta, Agostino S Vaiano, Michele Reibaldi","doi":"10.1016/j.oret.2025.09.005","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>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.</p><p><strong>Design: </strong>Prospective, observational, multicenter study.</p><p><strong>Participants: </strong>Two hundred thirty-four eyes of 232 patients undergoing secondary IOL implantation using a standardized sutureless intrascleral fixation technique.</p><p><strong>Methods: </strong>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.</p><p><strong>Main outcome measures: </strong>Changes in BCVA, refractive stability, PE, IOL tilt and decentration, ECD, and postoperative complications.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":5.7000,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Two-Year Visual, Refractive, and Anatomical Outcomes of Sutureless Intrascleral One-Piece IOL Fixation: A Prospective Study.\",\"authors\":\"Paola Marolo, Guglielmo Parisi, Fabio Conte, Francesca Cimorosi, Davide Tibaldi, Matteo Fallico, Mario Damiano Toro, Enrico Borrelli, Lorenzo Motta, Agostino S Vaiano, Michele Reibaldi\",\"doi\":\"10.1016/j.oret.2025.09.005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>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.</p><p><strong>Design: </strong>Prospective, observational, multicenter study.</p><p><strong>Participants: </strong>Two hundred thirty-four eyes of 232 patients undergoing secondary IOL implantation using a standardized sutureless intrascleral fixation technique.</p><p><strong>Methods: </strong>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.</p><p><strong>Main outcome measures: </strong>Changes in BCVA, refractive stability, PE, IOL tilt and decentration, ECD, and postoperative complications.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":19501,\"journal\":{\"name\":\"Ophthalmology. Retina\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":5.7000,\"publicationDate\":\"2025-09-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Ophthalmology. 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Two-Year Visual, Refractive, and Anatomical Outcomes of Sutureless Intrascleral One-Piece IOL Fixation: A Prospective Study.
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.
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.
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