A Novel Rescue Surgical Technique for Stabilization of Scleral-Fixated FIL SSF Intraocular Lens (Carlevale Lens): A Case Report

Abstract

Introduction

The FIL SSF intraocular lens (IOL) (Carlevale, Soleko, Italy) is a sutureless scleral-fixated lens designed for cases of aphakia with insufficient capsular support. While generally stable, intraoperative complications such as haptic rupture may occur. We present a novel rescue technique for scleral fixation of FIL SSF IOL following rupture of the trans-scleral plug during combined penetrating keratoplasty, three-port pars plana vitrectomy, and IOL implantation.

Case Presentation

During the combined procedure, rupture of one FIL SSF IOL plug was identified. The compromised haptic was externalized into the subconjunctival space. The sclerotomy was sutured to secure the haptic, achieving both immobilization and stable positioning of the IOL. Postoperatively, the patient was followed for 6 months. Best corrected visual acuity reached 0.2 (decimal scale), intraocular pressure was stable at 14 mm Hg in the left eye, the corneal graft remained clear, and the FIL SSF IOL maintained centration without further complications.

Conclusion

This case demonstrates that intraoperative rupture of the FIL SSF IOL haptic can be effectively managed using a scleral anchoring technique. This approach provides a stable and safe alternative for salvaging IOL fixation during complex anterior and posterior segment surgeries.

Introduction

Inadequate capsular support is usually combined with other ocular pathologies, involving both the anterior and posterior segment of the eye [1–3]. Especially in post-traumatic cases, coexistence of these conditions emerges as a greater surgical challenge and highlights the importance of comprehensive and multidisciplinary management to restore and optimize visual anatomy and function in affected individuals [2, 3]. In such complex cases with coexisting corneal pathology, compromised capsular support has been addressed by combining corneal transplantation with implantation of various intraocular lens (IOL) alternatives, such as anterior chamber intraocular lenses, iris-fixated intraocular lenses, and sutured or sutureless scleral-fixated IOLs [3, 4].

Lately, however, sutureless scleral fixation of FIL SSF IOL (Carlevale, Soleko, Italy) has gained increasing popularity for eyes with inadequate capsular support, due to the significant advantages it offers [5, 6]. Although its use has a very low rate of complications [7], facing them intraoperatively, especially in intricate cases and combined surgeries, can be very challenging. In this report, we describe a novel rescue surgical technique of scleral anchoring of FIL SSF IOL due to a broken trans-scleral plug during a penetrating keratoplasty surgery combined with three-port pars plana vitrectomy and IOL implantation.

Case Presentation

A 73-year-old patient with a history of penetrating ophthalmic injury in his left eye 6 months earlier was referred to our clinic for the management of corneal opacification. He had undergone a lensectomy in the left eye 3 years ago. Best corrected visual acuity at the presentation was 1.0 (decimal scale) in the right eye and counting fingers in the left eye. On slit lamp examination, the patient presented with a slight conjunctival injection and blood staining of the whole cornea. Intraocular pressure was 12 mm Hg in the right eye and 10 mm Hg in the left eye. Fundoscopy was not possible. A B-scan ultrasonography revealed no retinal detachment or other retinal pathology.

Penetrating keratoplasty accompanied by posterior vitrectomy and scleral-fixated IOL implantation was planned. The donor corneal button was meticulously trephined at a diameter of 8.25 mm and then prepared and sutured into place, using 16 interrupted non-absorbable 10.0 Nylon sutures. After a twenty-three-gauge three-port pars plana vitrectomy (Constellation system; Alcon, Inc. Hunenberg, Switzerland), the FIL SSF IOL was introduced into the anterior chamber using a Viscojet injector (Medical Viscojet 2.2 mm) through a 2.75 mm clear corneal incision at the 11 o’clock position.

For scleral fixation of the FIL SSF IOL, we used the vitrectomy ports as plug fixation sites, a surgical variation that has been previously described [8–10]. A twenty-five-gauge intraocular forceps was inserted through the sclerotomy behind the iris, after the trocar had been removed, trying to grasp the leading IOL T-shaped plug. The forceps failed to grasp the trans-scleral plug and the IOL dropped on the posterior pole of the eye. After several surgical maneuvers trying to externalize the leading plug through the sclerotomy, it finally ruptured. To prevent graft endothelial damage, we avoided removal of the FIL SSF IOL through the anterior chamber of the eye, and we decided to suture and stabilize the remaining haptic to the sclera.

The remaining part of the haptic with the broken plug was grabbed with the intraocular forceps and externalized through the sclerotomy into the subconjunctival area. Two absorbable sutures 8.0 (Vicryl) were used to close and tighten the sclerotomy, enclosing and immobilizing the haptic there (shown in online Suppl. Digital Content 1; for all online suppl. material, see https://doi.org/10.1159/000549377). The trailing plug was subsequently externalized by the forceps through the other diametrically opposed sclerotomy, after the trocar had been removed. The plug was left in the subconjunctival region following the mini-invasive technique for FIL SSF IOL implantation described by Danese et al. [10] The T-shaped plug prevented backward movement of the haptic through the sclerotomy, anchoring the IOL at the wall of the eyeball. The remaining trocar and the infusion cannula were finally removed, and subconjunctival cefuroxime and dexamethasone were administered.

Up to 6 months after the surgical intervention, no complications were observed. Best corrected visual acuity was 0.2 (decimal scale) and intraocular pressure was 14 mm Hg in the left eye. The graft remained clear, and no signs of rejection or failure were presented. Moreover, the FIL SSF IOL remained well centered without tilt (shown in Fig. 1). The trailing plug was visible in the subconjunctival area, whereas the sutures of the sclerotomy were still present at the site, where the leading plug was immobilized through the sclera (shown in Fig. 2).

Fig. 1.

Slit lamp photo of the operated eye 2 weeks post-op. The FIL SSF IOL remains well centered. The ruptured T-shaped plug is located on the optic of the lens.

Fig. 2.

Slit lamp photo of the eye 1 month post-op. Sutures are still visible in the subconjunctival area, where the ruptured haptic has been squeezed in the sclerotomy.

Discussion

IOL implantation in eyes with absent or compromised capsular support poses a significant challenge for ophthalmic surgeons [8]. Although a variety of IOL alternatives exist, FIL SSF IOL has offered a minimally invasive option with great advantages and improved outcomes to address such cases [3, 6]. However, as with any surgical procedure, complications may arise [7]. In this report, we present a novel rescue surgical technique, designed to address intraoperative plug rupture and salvage FIL SSF IOL implantation.

FIL SSF IOL with its T-shaped trans-scleral plugs has emerged as a significant advancement in the armamentarium of IOL alternatives for eyes with inadequate capsular support [3, 6]. Except for the ability for sutureless scleral fixation, it is designed to minimize lens tilting and overcome various significant postoperative risks that have been shown to be associated with the previously employed IOL options [5, 6]. Furthermore, minimally invasive techniques have been implemented for scleral anchoring of the haptics, making the surgery even simpler and less time-consuming [8, 10].

More specifically, Danese et al. have described subconjunctival positioning of FIL SSF IOL anchors without creating a scleral flap. According to this technique, the conjunctiva is slightly displaced when placing the trocars, so that the plugs are covered by intact conjunctiva when externalized into the subconjunctival space through the sclerotomies. The authors have also presented a retrospective case series of thirty-five eyes with 2 years follow-up, demonstrating that subconjunctival anchor placement yields favorable outcomes without complications. No cases of endophthalmitis or erosion have been reported. In particular, the soft hydrophilic material of FIL SSF IOL favors subconjunctival positioning of its plugs without any interference or damage to the overlying conjunctiva [10]. In our case, we similarly aimed to fixate the FIL SSF IOL trans-sclerally, leaving the T-shaped plugs in the subconjunctival space to reduce invasivity.

In addition, inadequate capsular support often arises in the context of complex ocular pathologies, including corneal conditions that necessitate the simultaneous performance of a corneal transplantation [2]. The prevention of postoperative tilting that FIL SSF IOL offers [5, 6] constitutes an asset over different IOLs in terms of postoperative corneal graft survival, making it a promising solution for complex cases of aphakia and concurrent corneal pathology.

Additional to its benefits, FIL SSF IOL implantation carries a low risk of complications. Intraoperative plug rupture is reported to be the most common event according to literature [7]. Traditional approaches may not be sufficient to address this complication, such as in our case, where the corneal graft could be compromised. Therefore, we present a novel rescue technique to address haptic rupture, by safely anchoring the ruptured plug to the sclera. Interestingly, our technique offered a safe solution without any related complications or decentration of the IOL. We believe this innovative approach equips ophthalmic surgeons with a valuable way to adapt and manage an unforeseen challenge during such complex surgeries, ultimately improving the safety and success rates of FIL SSF IOL implantation in cases where capsular support is lacking.

Despite the potential benefits, there is a need for further studies, larger clinical evidence, and longer follow-up to fully evaluate the safety and efficacy of the new technique. Long-term evaluation of visual acuity, corneal endothelial cell density and IOL positioning will provide valuable insights into the durability of this approach. Of course, surgical technique selection should always be tailored to individual patient’s needs and ocular characteristics.

In conclusion, our novel rescue surgical technique provides an effective way to respond to a common intraoperative complication associated with FIL SSF IOL implantation, namely, plug rupture. Further studies are warranted to refine the technique and optimize patient outcomes.

Statement of Ethics

This study protocol was reviewed and approved by the “G. Gennimatas” Hospital, Athens Ethics Committee on January 15, 2024, and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from the patient for publication of the details of their medical case and any accompanying images. This report does not contain any personal information that could lead to identification of the patient. The CARE Checklist has been completed by the authors for this case report, attached as online supplementary material.

Conflict of Interest Statement

The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding Sources

The authors received no financial support for the research, authorship, and/or publication of this article.

Author Contributions

P. Petrou contributed to the conception and design of the work, acquisition of data, writing of the manuscript, review of the literature and final critical revision of the manuscript. K. A. Togka contributed to the acquisition of data and images, writing of the manuscript, review of the literature, data analysis and interpretation of the results and final critical revision. M. Katsimpras, V. N. Pililis, D. G. Vakalopoulos, and M. S. Chatzea contributed to the acquisition of data and images, review of the literature, data analysis and interpretation of the results. G. D. Kymionis contributed to the conception and design of the work, acquisition of data, writing of the manuscript, review of the literature and final critical revision of the manuscript and supervised the whole project. All authors provided critical feedback and approved the final manuscript.

Funding Statement

The authors received no financial support for the research, authorship, and/or publication of this article.

Data Availability Statement

All data generated or analyzed during this study are included in this article and its online supplementary material files. Further inquiries can be directed to the corresponding author.