Clinical Outcomes And Complications Of A Sutureless Scleral-Fixated Intraocular Lens
Published 2025 - 43rd Congress of the ESCRS
Reference: FP25.14 | Type: Free paper | DOI: 10.82333/t1ca-gf11
Authors: Nicolás Kahuam López* 1 , Mauricio Muleiro Alvarez 1 , Guillermo R. Vera-Duarte 1 , Gustavo Ortiz-Morales 1 , Alejandro Navas 1 , Arturo Ramirez-Miranda 1 , Enrique O. Graue-Hernandez 1
1Cornea and Refractive Surgery,Instituto de Oftalmologia Conde de Valenciana,Mexico City,Mexico
Purpose
A sutureless scleral-fixated IOL, the Carlevale (SSF IOL, Soleko), has been available for aphakia correction with insufficient capsular bag stability for a few years.
This study examines the long-term safety and effectiveness of this IOL. The long-term intrascleral position of the haptics is of particular interest, as a subconjunctival position is assumed to increase the risk of complications. Due to the method used to fix the IOL, good centering can theoretically be assumed, which was also investigated in this study.
Setting
This study was conducted at a University Eye Clinic.
Methods
In this clinical study, 38 eyes treated with the Carlevale IOL were included and systematically followed up. Complications in the early and long-term postoperative course were recorded. The uncorrected distance visual acuity (UDVA), the manifest refraction and the best corrected distance visual acuity (CDVA) were examined at the pre- and postoperative visit. The position of the haptics and centration and tilt of the IOL were assessed using anterior segment OCT (Anterion).
Results
Follow-up ranged from 3 to 28 months with a median of 18 months. On average, the preoperative UDVA was 1.55 ± 0.63 logMAR, the CDVA was 0.52 ± 0.51 logMAR and the postoperative UDVA was 1.1 ± 0.71 logMAR while CDVA increased to 0.45 ± 0.59 logMAR.
The most frequent complications were reverse pupillary block (21% of eyes), postoperative macular edema (7.9%), extrusion of the IOL haptic (5.3%) and retinal detachment (2.6%). On average, the IOLs showed a horizontal decentration of 0.22 ± 0.15 mm and a vertical decentration of 0.40 ± 0.28 mm as well as a horizontal tilt of 4.68 ± 2.71° and a vertical tilt of 3.51 ± 3.67°. On average, patients rated their satisfaction with the treatment as 4.00 ± 1.17 on a 5-point Likert scale.
Conclusions
The Carlevale IOL is a safe option for aphakia correction with insufficient capsular bag stability. The risk of complications increases with the presence of comorbidities. The functional results were satisfactory. The haptics were predominantly intrascleral with adequate preparation of the scleral pockets. Centration and tilt were low and patient reported high satisfaction with the postoperative outcome.