Search Results (19)

Background/Objectives: Different surgical techniques are available in cases of missing or insufficient capsular bag support. Next to the anterior chamber or iris-fixated intraocular lenses (IOL), the implantation of the Carlevale IOL provides a sutureless and scleral fixated treatment method. Methods: In a retrospective single-center study, the perioperative data of 100 patients who consecutively received a scleral fixated Carlevale IOL combined with a 25 gauge (G) pars plana vitrectomy between September 2021 and June 2024 were investigated. The intraoperative and postoperative results were analyzed in terms of complication rates and refractive outcomes. Results: IOL dislocation was the most common surgical indication (50%) for sutureless Carlevale IOL implantation, followed by postoperative aphakia in 35 patients (35%). Nearly every fourth patient (24%) had a preoperative traumatic event, and 21% had pseudoexfoliation (PEX) syndrome. The average surgery time was 60.2 (±20.1) min. Intraoperative intraocular hemorrhage occurred in seven cases, and IOL haptic breakage in two patients. Temporary intraocular pressure fluctuations represented the most common postoperative complications (28%). Severe complications such as endophthalmitis or retinal detachment were not observed in our cohort. The mean refractive prediction error was determined in 67 patients and amounted to an average of −0.7 ± 2.0 diopters. The best corrected visual acuity (BCVA) at the last postoperative follow-up showed an improvement of 0.2 ± 0.5 logMAR (n = 76) compared to the preoperative BCVA (p = 0.0002). The postoperative examination was performed in 72% of the patients, and the mean follow-up period amounted to 7.2 ± 6.4 months. Conclusions: Overall, sutureless and scleral fixated implantation of the Carlevale IOL represents a valuable therapeutic option in the treatment of aphakia and lens as well as IOL dislocation in the absence of capsular bag support with minor postoperative complications and positive refractive outcomes. Full article

Objective: The aim of this study was to evaluate the clinical outcomes of sutureless scleral-fixated (SSF) Soleko Fil Carlevale intraocular lens (SC-IOL) implants associated with pars plana vitrectomy (PPV) in patients with aphakia secondary to complicated cataract surgery or IOL luxation nationwide. Methods: A multicenter, national, retrospective study of 268 eyes (268 patients) which underwent simultaneous PPV and SC-IOL implantation was conducted. Demographics; ocular data; pre-surgical, surgical and post-surgical details; and refractive results were collected. Intra- and postoperative complications and management details were described. Best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central retinal thickness (CRT) were collected at 1 week and at 1, 3, 6 and 12 months post-surgery. Kaplan–Meier curves were constructed to assess the cumulative probability of postoperative BCVA, IOP levels, macular edema (ME) and corneal decompensation. Results: The cumulative probability of final VA ≤ 0.3 logMAR was 64.4% at 12 months follow-up. The probability of IOP > 21, ≥25 and ≥30 mmHg was 29.8%, 16.9% and 10.1%, respectively, and the cumulative probability of IOP-lowering treatment was 42.3% at 12 months. Glaucoma surgery was required in 3.7% of the eyes (10/268). The cumulative probability of postoperative ME development was 26.6% at 12 months, managed with topical treatment alone (73.5%) and intravitreal injections (26.5%). Corneal transplantation was required in 3.7% of the eyes (10/268). Conclusions: Sutureless scleral-fixated SC-IOL is an adequate therapeutic alternative in the management of aphakia with good visual results and an acceptable safety profile in routine clinical care. Longer-term studies are needed to evaluate its results and complications compared to other therapeutic alternatives. Full article

Background: Artificial iris (AI) implantation is an innovative and increasingly utilized surgical procedure for injured eyes with iris trauma. Methods: A 76-year-old female and a 34-year-old male presented at the emergency department with a traumatic corneo-scleral laceration and perforated corneal ulcer, respectively. Emergency surgeries were performed to restore ocular integrity. In both cases, a modified surgical technique involving the implantation of an AI was performed; however, two different models of AI were used. Results: The AIs were sutured with four stitches directly to the scleral-fixated (SF) intra ocular lens (IOL), and the AI-IOL complexes were implanted, as a single unit, and fixated to the sclera using the lens haptics. Before and after the surgery, patients underwent a comprehensive eye examination, including a visual acuity test. The AI-SF IOL complexes remained well positioned, with no intraocular or extraocular complications observed during the follow-up evaluations of both patients. Conclusions: We reported a straightforward and repeatable modified surgical technique for two patients with two models of AI, both sutured to the SF IOL and fixated to the sclera, as a single unit. This approach may serve as an excellent alternative for managing aphakic eyes with extensive iridodialysis or partial aniridia. Full article

Marfan syndrome (MFS) is a genetic disorder that affects the connective tissue in several systems, with ocular, cardiovascular, and skeletal system manifestations. Its ocular manifestations include ectopia lentis (EL), myopia, astigmatism, and corneal abnormalities. This review examines refractive alterations related to MFS such as EL, microspherophakia, lens coloboma, altered corneal biomechanics (flattening, thinning, and astigmatism), and myopia and their impact on visual acuity. The pathogenesis of these manifestations stems from mutations in the FBN1 gene (encoding fibrillin-1). Moreover, the current medical and surgical management strategies for MFS-related refractive errors, including optical correction (eyeglasses, contact lenses, etc.), and surgical interventions like lensectomy, intraocular lens (IOL) implantation (anterior chamber, posterior chamber, scleral-fixated, iris-fixated), and the use of capsular tension rings/segments are further discussed. Considering the likelihood of underdiagnosing and underestimating ocular involvement in MFS, this updated review highlights the critical need to identify and address these refractive issues to enhance the visual outcomes for those affected. Full article

We describe a novel experimental device, the VaMa (Vatavuk and Marić) artificial intraocular lens (IOL) capsule, and a method that enables all IOL types to be implanted in the bag. We present the application of the device and the procedure in patients with aphakia and native capsule damage and without efficient capsular support. The VaMa device and the method facilitate IOL exchange due to refractive errors and, in the case of their invention, the implementation of superior IOLs in the future. The postoperative results after the implantation of the VaMa capsule along with IOLs in three patients are promising, with significant visual improvement and without adverse events 7 to 10 months postoperatively. Full article

Background: The aim of this retrospective study was to compare the surgical and refractive outcomes using the Carlevale IOL (FIL SSF; SOLEKO) with those of the retropupillary-fixated Artisan IOL (Aphakia Model 205; OPHTEC), implanted through a 6 mm sclerocorneal tunnel incision in both groups. Methods: This study included 51 consecutive eyes (25 Carlevale and 26 Artisan IOLs). Due to complex preoperative conditions (e.g., dislocated polymethylmethacrylat IOL, luxated Cataracta rubra), all patients underwent lens explantation using a standardized 6 mm sclerocorneal tunnel incision and a 23 G or 25 G pars plana vitrectomy. Visual acuity (VA), spherical equivalent, refractive prediction error (PE), incision-suture time, and complication rates were recorded preoperatively and during the follow-up period. Results: The average follow-up period was 40.9 ± 5.7 days. VA improved by 0.28 ± 0.39 logMAR (p < 0.0001) in the Carlevale group and by 0.36 ± 0.47 logMAR (p < 0.0001) in the Artisan group. The improvement was comparable between both groups (p = 0.921). The deviation of the PE was −0.67 ± 0.56 in the Carlevale group and 0.34 ± 0.71 in the Artisan group (p < 0.0001). The mean incision-suture time was 42.5 ± 5.8 min in the Carlevale group and 28.2 ± 6.4 min in the Artisan group. Anterior chamber and vitreous hemorrhages were the most common complications, occurring in 12% in the Carlevale group and 17.2% in the Artisan group. Conclusions: The use of the Carlevale IOL, implanted using a sclerocorneal tunnel technique, presents a valid option for treating complex lens dislocations. The scleral fixation of the Carlevale IOL minimizes risks associated with iris fixation, such as chronic inflammation and pupil distortion, making it particularly suitable for patients with damaged irises. Full article

Objectives: This study aimed to describe the outcomes of a staged procedure combining Descemet membrane endothelial keratoplasty (DMEK) and sutureless scleral fixation (SSF) of a one-piece intraocular lens (IOL) in a case series. Co-performing endothelial keratoplasty (EK) and SSF is associated with intraoperative and postoperative complications such as graft deployment difficulties, air migration, graft detachment, and IOL opacification or tilt, all of which are evaluated in this study. Methods: This is a retrospective observational case series. Clinical data were collected from eight eyes of eight patients who underwent DMEK for endothelial failure and had previously received an SSF with one-piece IOL following complete vitrectomy. During DMEK surgery, an air leak test was conducted to check for air migration into the posterior chamber. If instability was detected, pupilloplasty was performed. Intraoperative and postoperative data, including DMEK graft unfolding time, were collected. Corrected Distance Visual Acuity (CDVA), refraction, endothelial cell density (ECD), central corneal thickness (CCT), intraocular pressure (IOP), and complications were recorded over a 12-month follow-up period. Results: We performed pupilloplasty in four patients (50%). The median CDVA improved from preoperative 0.85 logMAR (range: 0.60 to 1.00) at baseline to 0.18 logMAR (range: 0.10 to 0.70, p = 0.012) at 12 months. The median refraction value changed significantly from −1.00 to −0.50 at 12 months. The median percentage reduction in ECD after 12 months was 33.4% (range 30 to 40). The median baseline CCT was 689 μm (range: 651 to 701) at baseline visit and 541.5 μm (range: 525 to 591, p = 0.008) at 12 months. The median IOP was reduced significantly during follow-up. The median graft unfolding time was 6 min (5 to 9). One patient required rebubbling for partial detachment on postoperative day one. No complications occurred within 12 months. Conclusions: The effective compartmentalization of the anterior and posterior chambers in vitrectomized eyes with an SSF one-piece IOL and pupilloplasty can facilitate critical steps of DMEK surgery in complex eyes. Additionally, the air leak test could prove useful in identifying the need for iris-lens diaphragm reconstruction. Full article

Background/Objectives: Postoperative intraocular lens (IOL) tilt is a risk associated with IOL scleral fixation. However, the cause of IOL tilt during IOL suturing remains unclear. Therefore, this study aimed to evaluate the surgical outcomes of a modified IOL suturing technique and investigate the factors contributing to postoperative IOL tilt and decentration. Methods: We included 25 eyes of 22 patients who underwent IOL suturing between April 2018 and February 2020. A modified IOL suturing technique that decreased the need for intraocular suture manipulation was used. Factors contributing to IOL tilt and decentration were investigated using an intraoperative optical coherence tomography (iOCT) system. Results: The mean postoperative best-corrected visual acuity improved from 0.15 ± 0.45 to −0.02 ± 0.19 (p = 0.02). The mean IOL tilt angle at the last visit after surgery was 1.84 ± 1.28 degrees. The present study reveals that the distance of the scleral puncture site from the corneal limbus had a stronger effect on IOL tilt; meanwhile, the suture position of the haptics had a greater effect on IOL decentration. Conclusions: The modified IOL suturing technique, which avoids intraocular suture handling, had favorable surgical outcomes with improved postoperative visual acuity and controlled IOL tilt and decentration. Accurate surgical techniques and careful measurement of distances during surgery are crucial for preventing postoperative IOL tilt and decentration. Full article

Objectives: This study compared long-term surgical outcomes of the scleral flap versus scleral pocket technique for sutureless intrascleral one-piece intraocular lens (IOL) fixation. Methods: A retrospective comparative study was conducted at a single center, involving consecutive patients undergoing sutureless intrascleral one-piece IOL implantation, between January 2020 and May 2022. Eyes were divided into two groups based on the surgical technique: group 1 underwent scleral flap (n = 64), and group 2 received scleral pocket technique (n = 59). Visual acuity, refractive outcomes, and complications were assessed over a minimum 24-month follow-up period. Results: Both groups showed improvements in best-corrected visual acuity (BCVA), increasing from 0.84 ± 0.56 logMAR at baseline to 0.39 ± 0.23 logMAR (p = 0.042) at 24 months in group 1 and from 0.91 ± 0.63 logMAR at baseline to 0.45 ± 0.38 logMAR (p = 0.039) at 24 months in group 2. No significant differences in BCVA were observed between the groups at baseline (p = 0.991), 12 (p = 0.496) and 24 months (p = 0.557). Mean spherical equivalent (−0.73 ± 1.32 D in group 1 and −0.92 ± 0.99 D in group 2, p = 0.447), refractive prediction error (−0.21 ± 1.1 D in group 1 and −0.35 ± 1.8 D in group 2, p = 0.377), and surgically induced astigmatism (0.74 ± 0.89 D in group 1 and 0.85 ± 0.76 in group 2, p = 0.651) were comparable between the two groups. An IOL tilt of 5.5 ± 1.8 and 5.8 ± 2.0 degrees (p = 0.867) and an IOL decentration of 0.41 ± 0.21 mm and 0.29 ± 0.11 mm (p = 0.955) were obtained, respectively, in group 1 and group 2 at 24 months. Mean endothelial cell density remained stable at 24 months in both groups (p = 0.832 in group 1 and p = 0.443 in group 2), and it was 1747.20 ± 588.03 cells/mm² in group 1 and 1883.71 ± 621.29 cells/mm² in group 2 (p = 0.327) at baseline, 1545.36 ± 442.3 cells/mm² in group 1 and 1417.44 ± 623.40 cells/mm² in group 2 (p = 0.483) at 24 months. No cases of endophthalmitis were observed. Conclusions: The scleral pocket technique for sutureless intrascleral one-piece IOL fixation is comparable to the traditional scleral flap technique in terms of long-term visual outcomes and safety. The scleral pocket technique offers a simplified approach and a viable option even for less experienced surgeons. Full article

Background/Objectives: To evaluate how the surgical technique and type of implanted intraocular lens influence the postoperative visual acuity and complications in ectopia lentis associated to Marfan syndrome patients. Materials and Methods: The medical records and videos of ectopia lentis surgeries in patients (children and adults) with Marfan syndrome, were retrospectively reviewed and compared. The study included 33 eyes that underwent four different intraocular lens implantation (IOL) techniques: IOL in conjunction with a simple capsular tension ring, IOL in conjunction with a Cionni modified capsular tension ring (m-CTR), two-point scleral IOL fixation and IOL with one haptic in the bag and one haptic sutured to the sclera. Results: Vision significantly improved from a mean preoperative visual acuity of 0.1122 to a mean postoperative visual acuity of 0.4539 in both age groups (p < 0.0001), with no difference in the primary outcome between children and adults. The most common surgical technique used in both age groups was IOL in conjunction with an m-CTR. There was only one major postoperative complication requiring additional surgery. Conclusions: Zonular weakness mainly influenced by age was the most important selection criterion for the surgical approach. Regardless of the technique employed, the postoperative visual acuity was improved in both adults and children. Full article

Background: The Carlevale lens (FIL SSF, Soleko IOL Division, Italy) is a new lens for suture-less scleral fixation. This paper aimed to systematically review articles on this lens, the surgical techniques used for its implantation, complications and outcomes. Methods: This systematic review was performed following the PRISMA guidelines. The search string used was “Carlevale” AND “scleral fixation” from inception until March 2024. For completeness, either case-control studies, case reports or case series written in English were included. The authors used the Newcastle–Ottawa scale for the case-control studies and the JBI Critical Appraisal Checklist for case reports and case series. Results: Twenty-nine articles were included. Scleral fixation with Carlevale lens can be performed by creating scleral flaps or, alternatively, by using scleral pockets. The two sclerotomies must be diametrically opposed, and are preferably created by 25-gauge trocars. A pars plana vitrectomy should be performed every time, and the design of the lens should be suitable for self-anchoring to the sclera; the most accredited strategy to achieve this is to avoid scleral sutures. There were only a few intraoperative and postoperative complications reported; vitreous hemorrhages were the most frequent intraoperative events, while the most relevant postoperative complications were vitreous hemorrhages, cystoid macular oedema and transient variations in the intraocular pressure. Excellent results have been obtained in terms of BCVA, IOL centration and stability, mean intraocular pressure, postoperative spherical equivalent, separation between anterior and posterior chamber and the distance of the IOL from anterior chamber structures. Conclusions: The foldable hydrophilic design of the Carlevale lens has shown good effectiveness, IOL stability and few intra and post-operative complications. Full article

Background: The purpose of the study is to compare the visual outcomes and complications of sutured scleral fixation (SSF), a traditional and conservative surgical approach, and the newer and faster Yamane technique for secondary intraocular lens placement. Methods: A literature search was performed on PubMed, Embase, and Scopus on studies published between 1 July 2017 to 29 September 2023. Outcomes analyzed included the final best corrected visual acuity (BCVA) between 3 and 12 months to assess the effectiveness of the procedure, post-operative month (POM) 1 BCVA to assess the speed of visual recovery, endothelial cell count (ECC), absolute refractive error, surgical duration, and complication rates. Additional subgroup analyses were performed based on surgeon experience with the technique. Single-surgeon studies had an average of 26 procedures performed, whereas multiple-surgeon studies averaged only 9 procedures performed; these were then used to delineate surgeon experience. A sample-size weighted mean difference (MD) meta-analysis was performed across all variables using RevMan 5.4.1; p < 0.05 was considered statistically significant. Results: Thirteen studies with 737 eyes were included: 406 eyes were included in the SSF group, and 331 eyes were included in the Yamane group. There was no significant difference in the final BCVA between groups in both the single-surgeon versus multiple-surgeon studies (MD = −0.01, 95% CI: [−0.06, 0.04], p = 0.73). In the single-surgeon studies, the BCVA at POM1 was significantly improved in the Yamane group compared to SSF (MD = −0.10, 95% CI: [−0.16, −0.04], p = 0.002). In the multiple-surgeon studies, there was no significant difference in BCVA at POM1 (MD = −0.06, 95% CI: [−0.16, 0.04], p = 0.23). The Yamane group had a shorter surgical duration than SSF in both single-surgeon and multiple-surgeon studies (MD = −24.68, 95% CI: [−35.90, −13.46], p < 0.0001). The ECC, refractive error, and complication rates did not significantly differ amongst all groups. Conclusions: The Yamane technique demonstrated similar long-term visual outcomes and complication rates to the traditional SSF. Visual recovery was significantly faster in the Yamane group in the single-surgeon studies. The operative times were shorter across all Yamane groups. Based on these findings, it is advisable to consider the Yamane technique as a viable, and perhaps preferable, option for patients requiring secondary IOL placement, alongside traditional SSF methods. Full article

Purpose. To revise the current literature on FIL SSF (Carlevale) intraocular lens, previously known as Carlevale lens, and to compare their outcomes with those from other secondary IOL implants. Methods. We performed a peer review of the literature regarding FIL SSF IOLs until April 2021 and analyzed the results only of articles with a minimum of 25 cases and a follow-up of at least 6 months. The searches yielded 36 citations, 11 of which were abstracts of meeting presentations that were not included in the analysis because of their limited data. The authors reviewed 25 abstracts and selected six articles of possible clinical relevance to review in full text. Of these, four were considered to be sufficiently clinically relevant. Particularly, we extrapolated data regarding the pre- and postoperative best corrected visual acuities (BCVA) and the complications related to the procedure. The complication rates were then compared with those from a recently published Ophthalmic Technology Assessment by the American Academy of Ophthalmology (AAO) on secondary IOL implants. Results. Four studies with a total of 333 cases were included for results analysis. The BCVA improved in all cases after surgery, as expected. Cystoid macular edema (CME) and increased intraocular pressure were the most common complications, with an incidence of up to 7.4% and 16.5%, respectively. Other IOL types from the AAO report included anterior chamber IOLs, iris fixation IOLs, sutured iris fixation IOLs, sutured scleral fixation IOLs, and sutureless scleral fixation IOLs. There was no statistically significant difference in the rates of postoperative CME (p = 0.20), and vitreous hemorrhage (p = 0.89) between other secondary implants and the FIL SSF IOL, whereas the rate of retinal detachment was significantly less with FIL SSF IOLs (p = 0.04). Conclusion. The results of our study suggest the implantation of FIL SSF IOLs is an effective and safe surgical strategy in cases where there is a lack of capsular support. In fact, their outcomes seem to be comparable to those obtained with the other available secondary IOL implants. According to published literature, the FIL SSF (Carlevale) IOL provides favorable functional results with a low rate of postoperative complications. Full article

Here, we present a case of floppy iris leading to positional pupillary capture by a sutureless, scleral-fixated intraocular lens (IOL) causing recurrent uveitis-glaucoma-hyphema (UGH) syndrome. The patient developed recurrent episodes of UGH syndrome after dislocated IOL removal and the placement of sutureless, scleral-fixated IOL. Gravitationally dependent pupillary capture was noted with the superior iris moving in front of and behind the IOL, depending on head positioning. Ultrasonography showed a floppy iris that moved with shifting gaze. The lack of the capsular bag may have contributed to extreme iris movements. This finding may be secondary to a combination of a lack of zonular support and capsular bag support as well as the lack of vitreous support following vitrectomy. When possible, secondary IOL placement behind a peripherally preserved capsular bag may reduce the risk of UGH. Full article

Purpose: To compare the refractive results between sutureless scleral fixation intraocular lens (IOLs) (Carlevale, Soleko) and suture-free scleral fixation three-piece IOLs (Sensar AR40, Johnson & Johnson) for secondary implantation in patients with IOL dislocation or aphakia. Methods: This is a monocentric retrospective study on 28 patients (28 eyes) with sutureless scleral fixation Carlevale IOL and 25 patients (25 eyes) with suture-free scleral fixation three-piece IOL. Best-corrected visual acuity (BCVA) evaluation, refractive measures and IOL tilt evaluation with anterior segment optical coherence tomography were conducted at one, three, six and twelve months after surgery. Point Spread Function (PSF) was measured using a total ocular aberrometer. Results: BCVA in both groups improved since the postoperative visit at 1 month and reached a stable value at 3 months At month 12, mean BCVA was 0.23 logMAR in group one and 0.32 logMAR in group two. Mean IOL tilt angle at 12 months was 2.76° ± 1.87 in group one and 2.51° ± 1.80 in group two. PSF at 12 months was 0.18 ± 0.09 in group one and 0.15 ± 0.05 in group two. There were no statistically significant differences (p > 0.05) for all comparisons. The post-operative complications were similar within the two groups. Conclusions: Our results show that secondary IOL implantation has similar visual and surgical outcomes when a sutureless Carlevale lens scleral fixation and a suture-free scleral fixation three-piece IOL are used. Full article