Carlevale Scleral Fixation Lens versus Gore-Tex Sutured Scleral Fixation Lenses: Surgical Outcomes and Safety

Pourpose To compare the surgical outcomes and safety between sutureless scleral fixation intraocular lens (IOLs) (Carlevale®, Soleko, Italy) and 4-point Gore-tex scleral fixated IOLs for secondary implantation in patients with IOL dislocation or aphakia Materials and Methods In this retrospective comparative study, two different scleral IOL implantation techniques were compared in patients without any capsular support. Medical records of 15 eyes from 15 patients who underwent secondary IOL implantation with sutureless scleral fixation using Carlevale lens (sutureless group) or conventional scleral fixation with Gore-tex suture (sutured group) between January 2022 and December 2024 were analyzed. Visual and refractive outcomes, as well as postoperative complications, were compared at baseline, at 1 and 3 months after surgery. The study included 8 transscleral Carlevale IOLS and 7 Gore-tex scleral fixated IOLS (using a Bausch and Lomb Akreos Adapt AO IOL), combined with pars plana vitrectomy Results In the postoperative period, both the Carlevale lens group and the Gore-Tex group showed good visual acuity, with significant improvements in vision at 3 months after surgery. LogMAR mean best-corrected visual acuity (BCVA) improved from 1.17 to 0.08 at three months after surgery in Carlevale group and from 1.33 to 0.06 in Gore-tex group (p < 0.05). Postoperative BCVA was similar in the 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 patient (13.3%) developed cystoid macular edema (CME). In the Carlevale group, there was one case of plug extrusion. No cases of suture erosion or rupture were observed in the Gore-Tex group Conclusions In our small study cohort, both secondary IOL implantation with sutureless scleral fixation using Carlevale lens and Gore-Tex sutured scleral IOL fixation resulted in excellent visual rehabilitation of patients with aphakia and subluxated lenses. Both surgical procedures can be considered adequate to correct aphakia in patients without capsular support or in complex cases where traditional “in the bag” IOL implantation method may not be feasible. Minimal complication rates were reported, making both techniques an attractive choice for secondary IOL implantation.