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Purpose <p>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.</p> Methods <p>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&#xa0;mm from the limbus, two circumferential partial-thickness scleral grooves, 4&#xa0;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&#xa0;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.</p> Results <p>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&#xa0;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 (<i>p</i> &lt; 0.001). The mean IOP showed a downward trend from 20.1 to 17.0 mmHg, although this difference did not reach statistical significance (<i>p</i> = 0.083). Overall, 87.3% of patients did not present any complications after 24 months from surgery.</p> Conclusion <p>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.</p>

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

  • 期刊论文

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  • 发表日期：

    2025年12月22日

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  • Danilo Iannetta,
  • Marc D de Smet,
  • Simone Febbraro,
  • Nicola Valsecchi,
  • Antonio Moramarco,
  • Oscar Matteo Gagliardi,
  • Lorenzo Motta,
  • Luigi Fontana,
  • Alessandro Lambiase

摘要

Purpose

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.

Methods

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.

Results

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.

Conclusion

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.