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A novel intraocular lens designed for sutureless scleral fixation: surgical series

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Abstract

Purpose

To report a retrospective series of patients implanted with a novel hydrophilic acrylic single-piece intraocular lens (IOL) designed for sutureless scleral fixation (FIL-SSF Carlevale lens, Soleko, Italy) injectable through a 2.2-mm incision.

Methods

Seventy-eight patients with minimum 6-month follow-up were divided into 6 groups: dropped nucleus, luxated IOL, trauma, aphakia, IOL exchange, and Marfan’s syndrome. Surgery included peritomy and scleral flap creation at 3 and 9 o’clock position. The IOL was then injected and grasped with 25G forceps through a hole created 2 mm posterior to the limbus underneath the sculped scleral flap.

Results

The study included 78 patients (mean age 71.9 ± 12.6 years) and average follow-up 10.2 ± 4.2 months. Average surgery duration was 69.4 ± 26.1 min and vision significantly improved from 0.86 ± 0.56 logMAR to 0.38 ± 0.42 logMAR at 6 months post-operative (p < 0.001). Intraoperative complications included corneal edema, retinal tears, and vitreous bleeding each in 2/78 patients (2.5%); 1/78 (1.3%) localized retinal detachment and 1/78 (1.3%) rupture of one T-shaped IOL harpoon. Post-operative complications included 4/78 (5.1%) cystoid macular edemas, 2/78 retinal tears, 2/78 retinal detachments, 2/78 developed ocular hypertension, and 1/78 corneal decompensation requiring DSAEK.

Conclusion

The Carlevale lens is designed for sutureless intrascleral fixation and can be successfully used in a variety of indications including difficult trauma cases with good rehabilitation. An implant requires experience and delicate manipulation.

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Acknowledgments

The authors would like to thank the Fondazione Roma for support.

Author information

Authors and Affiliations

  1. IRCCS Ospedale Policlinico San Martino, Genoa, Italy

    Tommaso Rossi & Serena Telani

  2. IRCCS Policlinico San Martino – UOC Oculistica, Largo Rosanna Benzi 2, 16100, Genoa, Italy

    Tommaso Rossi

  3. Arcispedale Santa Maria Nuova, Reggio Emilia, Italy

    Danilo Iannetta & Luigi Fontana

  4. St Paul’s Eye Unit, Royal Liverpool University Hospital, Liverpool, UK

    Vito Romano

  5. Karol Wojtyla Hospital, Rome, Italy

    Carlo Carlevale

  6. Department of Ophthalmology, San Marino Hospital, San Marino, Republic of San Marino

    Matteo Forlini, Aurelio Imburgia & Alessandro Mularoni

  7. IRCCS Fondazione G.B. Bietti ONLUS, Rome, Italy

    Guido Ripandelli

Authors
  1. Tommaso Rossi
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  2. Danilo Iannetta
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  3. Vito Romano
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  4. Carlo Carlevale
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  5. Matteo Forlini
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  6. Serena Telani
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  7. Aurelio Imburgia
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  8. Alessandro Mularoni
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  9. Luigi Fontana
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  10. Guido Ripandelli
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Contributions

T. Rossi: manuscript writing and study design; D. Iannetta: data search, proof reading, and study design; V. Romano: data search and manuscript writing; C. Carlevale: manuscript writing and proof reading; M. Forlini: data search and proof reading; S. Telani: data search and proof reading; A. Imburgia: data search; A. Mularoni: manuscript writing and proof reading; L. Fontana: manuscript writing and proof reading; and G. Ripandelli: data search and proof reading.

Corresponding author

Correspondence to Tommaso Rossi.

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Conflict of interest

All authors with the exception of Carlo Carlevale certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript. Carlo Carlevale receives speaker honorarium from Soleko srl but does not own stock in Soleko, neither is a member of any committee related to this IOL commercialization.

Statement of ethics

Present research complies with the guidelines for human studies and was conducted ethically in accordance with the World Medical Association Declaration of Helsinki. Informed consent was obtained by patients involved in the study.

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Rossi, T., Iannetta, D., Romano, V. et al. A novel intraocular lens designed for sutureless scleral fixation: surgical series. Graefes Arch Clin Exp Ophthalmol 259, 257–262 (2021). https://doi.org/10.1007/s00417-020-04789-3

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  • DOI: https://doi.org/10.1007/s00417-020-04789-3

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