TRAUMA A novel intraocular lens designed for sutureless scleral fixation: surgical series Tommaso Rossi 1,2 & Danilo Iannetta 3 & Vito Romano 4 & Carlo Carlevale 5 & Matteo Forlini 6 & Serena Telani 1 & Aurelio Imburgia 6 & Alessandro Mularoni 6 & Luigi Fontana 3 & Guido Ripandelli 7 Received: 31 March 2020 /Revised: 18 May 2020 /Accepted: 1 June 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020 Abstract 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. Keywords Aphakia . Intraocular lens . Pars plana vitrectomy . Sutureless intraocular lens . Scleral fixation Introduction The implant of an intraocular lens (IOL) is the mainstay of cataract surgery and secondary aphakia correction, often achieving substantial visual rehabilitation. Whenever possible, elective in-the-bag IOL positioning of- fers unparalleled stability and optimal effective lens place- ment. In case of insufficient or non-existing capsular support [1], multiple alternative solutions have been deployed: anteri- or chamber IOLs [2], iris claw [3] and iris-sutured IOLs, sul- cus IOLs [4], iris fixation [5], sutured scleral fixation [6], and sutureless scleral fixation [7]. Salvage procedures securing dislocated IOLs have also been developed as well as a few special IOLs designed specifically for scleral suturing [8]. In 2014, Yamane described a sutureless scleral fixation technique [9], based on the “entrapment” of the distal portion haptic underneath a lamellar scleral flap, allowing both secondary implant and salvage of specific IOL types [10] and countless variants followed ever since [11]. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00417-020-04789-3) contains supplementary material, which is available to authorized users. * Tommaso Rossi tommaso.rossi@usa.net 1 IRCCS Ospedale Policlinico San Martino, Genoa, Italy 2 IRCCS Policlinico San Martino – UOC Oculistica, Largo Rosanna Benzi 2, 16100 Genoa, Italy 3 Arcispedale Santa Maria Nuova, Reggio Emilia, Italy 4 St Paul’s Eye Unit, Royal Liverpool University Hospital, Liverpool, UK 5 Karol Wojtyla Hospital, Rome, Italy 6 Department of Ophthalmology, San Marino Hospital, San Marino, Republic of San Marino 7 IRCCS Fondazione G.B. Bietti ONLUS, Rome, Italy Graefe's Archive for Clinical and Experimental Ophthalmology https://doi.org/10.1007/s00417-020-04789-3