A novel intraocular lens designed for sutureless scleral fixation: surgical series

Tommaso Rossi, Danilo Iannetta, Vito Romano, Carlo Carlevale, Matteo Forlini, Serena Telani, Aurelio Imburgia, Alessandro Mularoni, Luigi Fontana, Guido Ripandelli

Research output: Contribution to journalArticlepeer-review


Purpose: To report a retrospective series of patients implanted with a novel hydrophilic acrylic single-piece intraocular lens (IOL) designed for sutureless scleral fixation (FIL-SSF Carlevale lens, Soleko, Italy) injectable through a 2.2-mm incision. Methods: Seventy-eight patients with minimum 6-month follow-up were divided into 6 groups: dropped nucleus, luxated IOL, trauma, aphakia, IOL exchange, and Marfan’s syndrome. Surgery included peritomy and scleral flap creation at 3 and 9 o’clock position. The IOL was then injected and grasped with 25G forceps through a hole created 2 mm posterior to the limbus underneath the sculped scleral flap. Results: The study included 78 patients (mean age 71.9 ± 12.6 years) and average follow-up 10.2 ± 4.2 months. Average surgery duration was 69.4 ± 26.1 min and vision significantly improved from 0.86 ± 0.56 logMAR to 0.38 ± 0.42 logMAR at 6 months post-operative (p < 0.001). Intraoperative complications included corneal edema, retinal tears, and vitreous bleeding each in 2/78 patients (2.5%); 1/78 (1.3%) localized retinal detachment and 1/78 (1.3%) rupture of one T-shaped IOL harpoon. Post-operative complications included 4/78 (5.1%) cystoid macular edemas, 2/78 retinal tears, 2/78 retinal detachments, 2/78 developed ocular hypertension, and 1/78 corneal decompensation requiring DSAEK. Conclusion: The Carlevale lens is designed for sutureless intrascleral fixation and can be successfully used in a variety of indications including difficult trauma cases with good rehabilitation. An implant requires experience and delicate manipulation.

Original languageEnglish
Pages (from-to)257-262
Number of pages6
JournalGraefe's Archive for Clinical and Experimental Ophthalmology
Issue number1
Publication statusPublished - Jan 2021


  • Aphakia
  • Intraocular lens
  • Pars plana vitrectomy
  • Scleral fixation
  • Sutureless intraocular lens

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience


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