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. 2025 Oct 16;14(20):7309.
doi: 10.3390/jcm14207309.

Anatomical and Functional Outcomes of Sutureless Scleral-Fixated Carlevale Intraocular Lens Implantation: A Retrospective Study

Affiliations

Anatomical and Functional Outcomes of Sutureless Scleral-Fixated Carlevale Intraocular Lens Implantation: A Retrospective Study

Adam Słoka et al. J Clin Med. .

Abstract

Background/Objectives: The purpose of this study was evaluation of the efficacy and the rate of complication of a foldable sutureless scleral-fixated intraocular lens (SSF-IOL), named Carlevale IOL, for the treatment of aphakia without sufficient capsular support due to trauma or complicated cataract surgery. Methods: Retrospective, consecutive interventional case series. All consecutive eyes with secondary implantation of aphakic SSF-IOL were considered. The primary outcomes were as follows: best corrected visual acuity (BCVA), refractive error (RE), and intraocular pressure (IOP). Secondary outcome was the occurrence of intraoperative and postoperative complications. Results: SSF-IOL was performed in 21 eyes of 21 patients (7 men and 14 women) with mean age of 74 years (range from 36 to 90 years). The mean follow-up time was 11.4 months. VA improved significantly (p = 0.0007) from 0.38 logMAR at baseline to 0.11 logMAR at the final follow-up. BCVA improved in 18 patients, remained equal in 2 cases, and worsened in 1 case. Mean postoperative RE was -0.83 Diopters (D) (Median = -0.50 D, SD = 1.05 D) and it was less than 1D in 61.9% of patients. Mean IOP at the end of the follow-up was 15.78 mmHg (ranged from 10 to 22 mmHg, SD = 3.65). In one patient a vitreous hemorrhage was observed intraoperatively, but it resolved spontaneously. Postoperative complications included one case of cystoid macular edema and one case of epiretinal membrane. Conclusions: Carlevale SSF-IOL implantation seems to be an effective and safe procedure, ensuring good visual outcomes with a low rate of complication in eyes indicated for secondary IOL implantation.

Keywords: Carlevale IOL; anterior segment surgery; cataract surgery; intraocular lens; intraocular lens implantation; intraocular lens surgery.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
The graphics show the surgical technique of sutureless scleral-fixated Carlevale intra-ocular lens implantation: (A) A 3 mm conjunctival peritomy at 3 and 9 o’clock positions. (B) Creation of 1 mm intrascleral pocket at 0°, 3 mm posterior to the limbus. (C) Intrascleral pocket at 180°, 3 mm from limbus. (D) Perpendicular sclerotomy (25 G needle), 2 mm posterior to the limbus. (E) A 2.2 mm clear corneal incision at 12 o’clock; insertion of 25 G vitrectomy forceps. (F) IOL injected; leading haptic grasped and externalized. (G) Trailing haptic grasped and externalized; both fixed in scleral pockets. (H) Conjunctival closure with single 8-0 Vicryl suture.

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