新規フラップレス手術手技によるFIL SSF眼内レンズの縫合糸固定なし強膜固定術：前向き研究

To evaluate the anatomical and functional outcomes of sutureless scleral fixation of FIL SSF intraocular lens (FIL SSF IOL- Soleko S.P.A. Pontecorvo, Italy) using a novel modified flapless surgical technique.

In this prospective study, patients older than 18 years with IOL-bag complex subluxation and a minimum follow-up of 24 months were included. At 2.5 mm from the limbus, two circumferential partial-thickness scleral grooves, 4 mm in length, were sculpted at 3 and 9 o'clock with a 300 microns pre-calibrated knife. According to two different variants of the same technique - trocarless or trocar-assisted - 25-G needles or 25-G trocars were respectively used to perforate the deep scleral grooves at the center. The FIL SSF IOL was injected through a 2.4 mm-wide corneal tunnel, and the T-shaped harpoons were gently driven out of the eye through the scleral holes and grooves. No scleral sutures were placed.

A total of 54 eyes of 54 patients were included. The mean age was 74.0 ± 14.2 years (range 31-96), and 40.7% were female. The mean intra-operative time was 79.9 ± 23.2 min. After 24 months from surgery (mean follow-up 25 ± 1 months), BCVA significantly improved from 0.9 ± 0.9 to 0.4 ± 0.5 LogMAR (p < 0.001). The mean IOP showed a downward trend from 20.1 to 17.0 mmHg, although this difference did not reach statistical significance (p = 0.083). Overall, 87.3% of patients did not present any complications after 24 months from surgery.

This novel flapless technique for sutureless FIL SSF IOL implantation appears safe, and it may represent a valuable alternative to existing methods, offering reduced tissue manipulation, faster surgical time, and a potentially shorter learning curve. It combines the unique features of this IOL design with minimal tissue manipulation, low risk, a shorter learning curve, and reduced operative time.