# 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.

## Key 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.