2-Year Outcomes Of A Novel Sutureless Scleral-Fixated (Ssf) Single Piece Carlevale Lens In The Management Of Aphakia And Lens Subluxation In A Scottish Patient Cohort.

To evaluate the surgical outcomes, feasibility and long-term complications of a novel Carlevale (Soleko) sutureless scleral-fixation (SSF) single-piece posterior chamber intraocular lens (IOL) for the management aphakic patients with a lack of capsular support or those with a subluxed IOL.

All surgeries were carried out at in Princess Alexandra Eye Pavilion (PAEP), Edinburgh, by two vitreoretinal surgeons (MM and HB). PAEP is a specialist eye centre in NHS Lothian’s University Hospitals Division providing tertiary care to the south-east of Scotland.

A retrospective cohort study was performed by reviewing our prospectively-maintained clinical database, along with the clinical and operative notes of patients who had insertion of a Carlevale IOL (Soleko). All surgeries were performed at PAEP from July 2020 to February 2022. All patients had a pars plana vitrectomy, before explantation of the subluxed IOL where necessary, and insertion of Carlevale IOL. Following the procedure, all patients underwent a standard post-operative ophthalmologic examination and were followed up long term.

We identified 16 patients that have undergone Carlevale SSF IOL insertion. Twelve patients had subluxation of an in-the-bag IOL and four were aphakic. All surgeries were performed with pars plana vitrectomy. Mean patients age was 79 (69 to 83) years. Mean follow-up was 15.1 ± 6.1 months. Mean axial length was 22.3 (19.8 to 23.8) mm and white-to-white distance was 11.4 ± 0.60 mm. Refractive spherical equivalent prediction error was −0.21 ± 0.51D. One patient required further surgery for an extruded scleral plug. No other complications were observed throughout the follow-up.

The Carlevale SSF IOL appears to be a safe and reliable option in the management of IOL subluxation and aphakia. The unique lens design provides good lens self-centration with minimal risk of haptic rupture and/or dislocation, thus providing accurate post-operative refractive outcomes with few complications. The posterior vaulting of the lens also conferred safe lens optic angulation and prevents iris-IOL chaffing, pigment dispersion and inflammation.