Fibrin glue-assisted Sutureless Scleral Fixation vs Sutured Scleral Fixation of Carlevale lens: a comparative study

Purpose To compare the surgical outcomes and safety between fibrin-glue assisted sutureless scleral fixation of Carlevale intraocular lens (Carlevale FIL-SSF IOLs, Soleko, Italy) and sutured scleral fixation of Carlevale lens for secondary implantation in patients with IOL dislocation or aphakia. Matherials and Methods In this retrospective multicenter comparative study, two different surgical techniques were compared in patients without any capsular support. Medical records of 15 eyes of 15 patients who underwent secondary IOL implantation with fibrin-glue assisted sutureless scleral fixation of Carlevale intraocular lens (Carlevale FIL-SSF IOLs, Soleko, Italy) and sutured scleral fixation of Carlevale lens between 1 January 2022 and 31 August 2025 were analyzed. Visual and refractive outcomes, as well as postoperative complications, were compared at baseline, at 1 and 3 months after surgery. The study is multicentric and included 7 fibrin glued-assisted SSF Carlevale lens (Group A - Ophthalmology department of East Kent Hospitals University, UK) and 8 sutured scleral fixation Carlevale lens (Group B - Ophthalmology Department of Azienda Ospedale Università di Padova), combined with pars plana vitrectomy. Results In the postoperative period, both the techniques employed for Carlevale lens implantation shoed good visual acuity, with significant improvements at 1 month after surgery and maintained during follow-up at 6 months. LogMAR mean best-corrected visual acuity (BCVA) improved from 1.17 to 0.08 at 3 months and 0.07 at 6 months after surgery in group A and from 1.33 to 0.06 at 3 months and to 0.05 at 6 months in group B (p < 0.05). Postoperative BCVA was similar in two groups, and no intergroup difference was noted. The complication rate was low in both groups, with the most common complication being intraocular hypertension: 2 eyes (13.3%) had a raised intraocular pressure (IOP> 25 mmHg), which was managed with topical therapy during the first month, 2 patients (13.3%) developed cystoid macular edema (CME), resolved with anti-inflammatory topical therapy. In the group B, there was one case of plug extrusion due to focal sclero-conjunctival erosion. Conclusions In our small study cohort, both secondary IOL implantation with fibrin-glue assisted sutureless scleral fixation of Carlevale intraocular lens and sutured scleral fixation of Carlevale lens resulted in optimal visual rehabilitation of patients with aphakia and subluxated lenses. Both surgical procedures may be considered adequate to correct aphakia in patients without capsular support or in complex cases where conventional “in the bag” IOL implantation method may not be feasible. Minimal complications rates were reported, making both techniques a valid choice for secondary IOL implantation.