A novel modified flapless surgical technique for sutureless scleral fixation of FIL SSF intraocular lens: a prospective study

TL;DR

A new flapless surgical technique for implanting a specific intraocular lens is shown to be safe and effective with improved vision and fewer complications.

Contribution

A novel modified flapless surgical technique for sutureless scleral fixation of FIL SSF IOL is introduced and evaluated.

Findings

BCVA significantly improved from 0.9 to 0.4 LogMAR after 24 months.

87.3% of patients had no complications after 24 months.

Surgical time averaged 79.9 minutes with minimal tissue manipulation.

Abstract

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.

The online version contains supplementary material available at 10.1007/s00417-025-07055-6.

Sutureless scleral fixation of intraocular lenses is a standard surgical option in eyes with insufficient capsular support. Existing techniques often require challenging steps such as scleral flap creation, haptic cauterization, or off-label use of three-piece IOLs, raising concerns about reproducibility and long-term safety.

Sutureless scleral fixation of intraocular lenses is a standard surgical option in eyes with insufficient capsular support.

Existing techniques often require challenging steps such as scleral flap creation, haptic cauterization, or off-label use of three-piece IOLs, raising concerns about reproducibility and long-term safety.

We describe a novel technique for sutureless scleral fixation of FIL SSF IOLs, which may eliminate the need for scleral flaps, haptic cauterization, or off-label devices. The approach demonstrated significant visual improvement and a low complication rate over a 24-month follow-up. This surgical technique could offer a simplified and reproducible alternative to existing techniques, with a favorable safety and efficacy profile.

We describe a novel technique for sutureless scleral fixation of FIL SSF IOLs, which may eliminate the need for scleral flaps, haptic cauterization, or off-label devices.

The approach demonstrated significant visual improvement and a low complication rate over a 24-month follow-up.

This surgical technique could offer a simplified and reproducible alternative to existing techniques, with a favorable safety and efficacy profile.

The online version contains supplementary material available at 10.1007/s00417-025-07055-6.

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