Intraocular lens (IOL) implantation without adequate capsular support is still a challenge for cataract surgeons. Several options are available and can be divided into three groups, according to the type of IOL to be implanted: anterior chamber IOL, iris-fixated IOL, and posterior chamber IOL (PC-IOL).1,2 Previous studies have tried to prove the superiority of one technique over the others based on outcomes and complications rates3; however, recent evidence does not support any significant difference.4–6 The best approach to manage these situations is yet to be found.
Theoretically, PC-IOLs could represent the preferred choice because they have an optical advantage due to their more natural anatomic location and proximity to the nodal point.7 The original technique for PC-IOL implantation, described by Malbran et al8,9 during the 1980s, entailed scleral suturing, a long learning curve, the need for a large corneal incision, and exposure to the risk of postoperative complications related to suture degradation and breakage.2 This led to research with the aim of developing new solutions, including sutureless techniques. However, these required greater efforts from the surgeon, probably because of the lack of IOLs specially designed for this purpose.2
Against this background, a sutureless scleral fixation IOL (SSF-IOL) was designed by one of the authors (CC); it has the advantage of being implantable in the posterior chamber without any suture. To the best of our knowledge, only one small case series describing the use of this IOL has been recently published.10
We report our experience along with an analysis of long-term visual acuity outcomes and complications in patients undergoing this SSF-IOL fixation technique.
Patients and Methods
This study was a retrospective, longitudinal, single-center, non-comparative case series that adhered to the tenets of the Declaration of Helsinki and was approved by the Santa Croce e Carle Hospital Ethics Committee. Informed consent was obtained from all patients before the surgical procedure was performed. All consecutive patients evaluated in the Ophthalmology Department of Santa Croce e Carle Hospital (Cuneo, Italy) between May 2015 and January 2019, with either aphakia or lens/single-piece IOL dislocation due to capsular or zonular defects, were analyzed. The exclusion criteria were age younger than 18 years, concomitant retinal or corneal surgery, severe health problems, and follow-up of less than 12 months.
Patients were evaluated with a complete preoperative clinical examination and carefully reexamined at 3, 6, and 12 months postoperatively. At each visit, they underwent measurement of endothelial cell density (ECD) (performed with an em-3000 endothelial specular microscope, software version 1.2.2, Tomey Corporation), corrected distance visual acuity (CDVA), which was assessed using the Revised 2000 Series ETDRS charts (Precision Vision) and expressed in logMAR units, subjective refraction (measured at 4 m and adjusted to infinity by subtracting 0.25 diopters [D]),11 and intraocular pressure (IOP) measured by Goldmann applanation tonometry. A macular evaluation with spectral-domain optical coherence tomography (SD-OCT) (Spectralis; Heidelberg Eye Explorer version 22.214.171.124; Heidelberg Engineering) was performed preoperatively and at 1 month postoperatively.
All biometric data for IOL power calculation were collected preoperatively and at 3 months postoperatively using an optical biometer (IOLMaster 500, software version 5.4; Carl Zeiss Meditec). All calculations were performed assuming in-the-bag IOL placement. Because in most cases a physiological anterior chamber was lacking, we relied on vergence formulas that do not use the anterior chamber depth as a predictor for the IOL position. Therefore, IOL power was calculated by means of the Hoffer Q, Holladay 1, and SRK/T formulas.12–14 The pre-operative target refraction was decided clinically based on a discussion between the patient and treating surgeon or attending ophthalmologist, the typical target being emmetropia or slight myopia (−0.25 to −0.50 D); only one patient chose −2.50 D as the target.
We selected both efficacy (final CDVA) and safety (ECD at 3, 6, and 12 months, as well as any complication) as the primary outcomes. Early and late postoperative complications were defined according to whether they developed before or at 1 month postoperatively, respectively. Intraocular hypotony and hypertension were defined as an IOP of less than 6 and greater than 21 mm Hg, whereas macular edema was defined based on characteristic OCT findings.15 IOL tilting was evaluated at 12 months with a 35-MHz UBM probe (HiScan Optikon 2000, BScan software version 126.96.36.199) by measuring the angle between the anterior surface of the IOL and a straight line passing through the ciliary process apexes. The IOL tilting was measured along both the vertical and horizontal planes and measurements were repeated until the maximum angle was found and recorded.16,17
The SSF Carlevale IOL (Soleko) (Figure 1) is a foldable one-piece acrylic IOL with two T-shaped self-blocking plugs on each haptic (angulation 10°). Its optic diameter is 6.5 mm and its total length is 13.2 mm. It is important to load the IOL into the cartridge under the microscope both to enable its correct placement (two notches are provided as a guide on the optic plate: upper right and lower left) and to detect an overlap of the injector soft tip on the haptic arm. When it happens, further maneuvers should be stopped, and the soft tip should be gently retracted and then pushed again until the IOL can be moved with no obstacles in the cartridge. The IOL is made of a 25% H2O acrylic material with an ultraviolet filter. Its optical power ranges from −5.00 to +35.00 D (Figure 1).
Photograph (A) and diagram (B) showing the structure of the new Carlevale sutureless scleral fixation intraocular lens (SSF-IOL; Soleko). Arrow points to the two notches on the optic plate (upper right and lower left).
All procedures were performed by one surgeon (ASV) under retrobulbar anesthesia. After conjunctiva dissection, two anteriorly hinged 3 × 3 mm scleral flaps were created at approximately 40% of scleral thickness. Their locations, marked with a 12-mm Mendez ring (Moria), were usually 180° apart, either along the vertical or the horizontal meridian, according to the patient's anatomy or whether there were any preexisting cataract surgery incisions. After marking with an inked caliper, a sclerotomy was created under each flap, 2 mm posterior to the limbus, using a 25-mm long, 25-gauge needle with a bent tip. Along the axis of the scleral flaps, a clear 2.2-mm corneal tunnel was created or was reopened, if the surgery was being performed due to complications of cataract surgery. Any lens and/or capsular bag residuals that were not useful for sulcus implantation were completely removed. A Sinskey hook could be introduced through the side port to help maneuvers in the anterior chamber. Once fully opened, the distal haptic of the IOL was gently grasped with a 25-gauge serrated forceps (Grieshaber; Alcon Laboratories, Inc) through the distal sclerotomy up to the scleral surface, blocking the two short arms one by one. The haptic should be grasped at the inter-junction of the T-shaped plugs to minimize the risk of haptic rupture. In the same way, the trailing T-block of the haptic was pulled outside the proximal sclerotomy. In the majority of cases a pars plana vitrectomy was performed using the Constellation 25-Gauge System (Alcon Laboratories, Inc). Miosis was achieved with acetylcholine (Miochol; Alcon Laboratories, Inc). The main corneal incision was closed with a 10-0 nylon suture, and the superficial scleral flap and conjunctiva using fibrin glue. Pars plana vitrectomy sclerotomies were all sutured with 7-0 polyglactin 910. All sutures were removed at least 1 month after surgery (Figure A, available in the online version of this article).
Photographs showing the implantation of the new Carlevale sutureless scleral fixation intraocular lens (SSF-IOL; Soleko). (A) Aphakic traumatized eye. (B) Grasping the T-shaped part of the haptic. (C) Its following externalization. (D and E) Trailing haptic grasping and following externalization through the sclerotomy. (F) appearance of the SSF-IOL after its anchoring into the sclera.
For the purposes of statistical analysis, all data were collected in a 2016 Microsoft Excel spreadsheet (Microsoft Corporation). Normality of data distribution was assessed by means of the Kolmogorov-Smirnov test. Repeated-measures analysis of variance (ANOVA) with Bonferroni's post-test was used to compare pre-operative and postoperative values with a normal distribution, such as ECD. The Friedman test (nonparametric repeated measures analysis of variance) with Dunn's post-test was used to compare preoperative and postoperative values without a normal distribution, such as CDVA and IOP. Pearson's correlation was used to correlate IOL tilting and CDVA. All statistical analyses were carried out using Instat (version 3.10; Graphpad Software, Inc).
Based on the results of Yamane et al18 and using G*Power3 software (software version 3.1.2), a calculation was performed to determine the sample size needed to detect a difference of 0.16 logMAR (range: 0.25 to 0.09 logMAR) (Snellen equivalent: 20/29) between the average CDVA at baseline and the 12-month follow-up in the study group, at a significance level of 5% and a power of 80%, assuming a standard deviation of 0.40 logMAR. The required sample size of the study was 52 cases, adjusted to 54 to account for follow-up drop out.
We originally evaluated data of 63 eyes of 58 patients; 9 eyes had to be excluded from the statistical analysis because they did not meet the inclusion criteria: 4 eyes due to combined surgery (2 for macular pucker surgery and 2 for Descemet stripping automated endothelial keratoplasty) and 5 eyes because of an incomplete follow-up. Therefore, 54 eyes of 50 patients (mean age: 62 ± 17 years; range: 19 to 90 years; 30 males) were included in the statistical analysis. Table 1 specifies the surgical indications and Table 2 the mean preoperative and postoperative biometric measurements.
Indications for SSF-IOL in 54 Eyes of 50 Patients
Preoperative and Postoperative Data of the 54 Eyes Analyzed
The mean preoperative CDVA was 0.93 ± 0.61 logMAR (median: 0.89; range: 0.08 to 2.30; mean Snellen equivalent: 20/170). This improved to 0.42 ± 0.34 logMAR at 3 months (median: 0.33; range: 0.04 to 2.00; mean Snellen equivalent: 20/53), 0.42 ± 0.37 logMAR at 6 months (median: 0.24; range: 0.04 to 2.00; mean Snellen equivalent: 20/53), and 0.38 ± 0.38 logMAR (median: 0.19; range: 0.00 to 2.00; mean Snellen equivalent: 20/48) at 1 year. The difference was statistically significant (P < .0001). Post-test analysis revealed a statistically significant difference between the preoperative CDVA and the postoperative CDVA at each follow-up (P < .05), but not among postoperative values. The safety index (CDVA preoperative / CDVA postoperative) was 2.19, 2.24, and 2.47 at 3, 6, and 12 months, respectively. Overall, 43 eyes (79.6%) demonstrated an improvement in CDVA from the preoperative to the last follow-up values, 9 eyes (16.7%) did not show any change and 2 eyes (3.7%) revealed a decrease in CDVA.
The mean IOP decreased from 15.02 ± 5.37 mm Hg (range: 8 to 40 mm Hg) preoperatively to 13.96 ± 3.45 mm Hg (range: 6 to 26 mm Hg), 13.78 ± 2.96 mm Hg (range: 6 to 21 mm Hg), 13.70 ± 2.72 mm Hg (range: 8 to 19 mm Hg), and 13.89 ± 2.82 mm Hg (range: 7 to 20 mm Hg) at 1, 3, 6, and 12 months, respectively. These differences were not statistically significant (P = .9005)
The mean corneal ECD decreased from 1,725.37 ± 528.06 cells/mm2 preoperatively to 1,683.04 ± 531 cells/mm2 at 3 months, 1,649.83 ± 526.90 cells/mm2 at 6 months, and 1,612.81 ± 522.91 cells/mm2 at 12 months. The difference was statistically significant (P < .0001). Post-test analysis revealed a significant difference between each paired comparison. The mean cell loss from baseline to the last follow-up was 112.44 ± 48.89 cells/mm2, which represents an average 6.51% loss at 1 year after surgery.
The IOL tilt value was 3.1° ± 1.1° (range: 1° to 5.5°) in the postoperative period at 12 months. A statistically significant correlation was found between IOL tilting at 12 months and CDVA (r2 = 0.258, r = 0.508, P < .0001) (Figure 2).
Postoperative findings of the new Carlevale sutureless scleral fixation intraocular lens (SSF-IOL; Soleko). (A) Ultrasound biomicroscopy 35-Hz probe: image showing the correct positioning of the haptic. (B) Slit-lamp microscopy of the T-shaped plugs under the scleral flap. (C and D) Image scan showing the T-shaped plugs fixed in the sclera with anterior segment optical coherence tomography Visante (Carl Zeiss Meditec) and Spectralis (Heidelberg Engineering), respectively.
Mean surgery time was 75.39 ± 25.74 minutes (range: 40 to 150 minutes). The most common concurrent intraoperative procedure was a posterior pars plana vitrectomy, which was done in 47 eyes (87%). Other concurrent procedures included IOL removal from either the anterior or posterior chamber in 12 eyes (22%), cataract extraction in 10 eyes (18.5%), and iridoplasty in 4 traumatized eyes (7.4%).
The most common intraoperative complication was the rupture of the IOL haptics, which occurred in 6 eyes (11%): in 4 cases at the distal T-shaped plugs during their extraction on the scleral surface and in 2 cases at the proximal haptic, which became stuck in the cartridge.
Among early complications, we observed a transient corneal edema in 5 cases (9.25%), a small inflammatory response in the anterior chamber in 4 eyes (7.40%), and a mild intraocular hemorrhage in 4 eyes (7.40%). No cases of ocular hypotony were observed, but ocular hypertension occurred twice (3.7%).
Among late complications, we observed 4 cases of macular edema (7.4%) and 2 cases of exposure of the haptics underneath the conjunctiva (3.7%), one in a patient with Marfan syndrome and one in a patient with high myopia. There was one retinal detachment (1.85%), again in a patient with Marfan syndrome, 3 months after the procedure. Of the 2 cases of decreased visual acuity (3.70%), one was due to the retinal detachment and one to an epiretinal membrane formation. There were no cases of postoperative endophthalmitis or IOL dislocation.
Surgeons are often called upon to perform secondary IOL implantation to manage either an aphakic eye or one with dislocation of a previous implant. Each approach has its advantages and its own set of disadvantages.1,8,19 Several options exist for scleral fixation techniques, which can be classified according to different criteria, such as whether sutures are needed, the model of IOL that is used, and even the way in which suture knots are placed.1,18–21 Complications associated with suturing techniques range from mild ones such as pseudo-phacodonesis, suture breakage or lens dislocation, to more severe ones, such as retinal detachment, suprachoroidal hemorrhage, and suture-related endophthalmitis.2 Since scleral-sutured IOLs were introduced, the technique and materials have been modified to improve success rates and reduce the risk of complications. New surgical approaches, such as Gore-Tex (W.L. Gore & Associates) sutures, have been developed to limit these complications,21,22 and SSF techniques have been introduced.18,19 However, in relation to such techniques, the data in the literature regarding IOL stability and complication types and rates have been contradictory.2,23
In this study, we demonstrated the efficacy and safety of a new technique and reported the data collected from our experience with the SSF Carlevale IOL, whose distinctive features are the small corneal incision that is required and the two T-shaped self-blocking plugs provided on each haptic to anchor the IOL to the sclera.
Although previous studies have reported a variable rate of decrease in CDVA (from 11% of eyes in the case of glued PC-IOLs to 29% eyes in the case of sutured PC-IOLs)24,25 we had only 2 cases (3.7%) with a visual decrease. We observed a visual acuity gain at 3, 6, and 12 months in almost 80% of cases, with a progressive clinical (but not statistically significant) improvement during the follow-up. Our results are in good agreement with previous studies.19,20,26 Interestingly, the CDVA at 12 months was correlated to IOL tilting; the low value of the latter (≤ 5.5°) helps to explain the good visual outcomes in our sample. Similar to other anterior segment surgeries,27 a small reduction in ECD was detected during the follow-up.
A recurrent intraoperative complication that required an IOL exchange was the rupture of the IOL haptic at the T-shaped terminal. It was observed only in the first 30 cases so it is mainly related to the surgeon's learning curve.
Our postoperative complications were comparable to those reported in previous studies of SSF-IOL insertion, but we did not detect any abnormal IOL tilting or dislocation, iris capture, hypotony, or severe IOP rise. Only mild and transient complications were observed in the early postoperative course.
Unlike what occurs with other transscleral fixation techniques (eg, Yamane et al18 or Agarwal et al19), we had no cases of iris capture, although we did not perform iridectomy to prevent a reverse pupillary block. Iris capture is likely to occur when the IOL is fixed too anteriorly, or when it can be tilted. In this study, the mean central anterior chamber depth (measured from epithelium to lens) value of 4.52 ± 0.36 mm (range: 3.76 to 5.45 mm) was higher than that reported by Ya-mane et al18 (4.28 mm). No dislocation or abnormal tilting was observed, in contrast to what other authors have reported with sutureless techniques.19,28 In the literature, IOL tilting and dislocation range from 3% to as high as 23% in sutured PC-IOL studies28–30; our data (3.1 ±1.1°) are comparable to those found in Yamane et al's case series.18 We speculate that the resulting position of the IOL, made possible by the haptic angulation of 10°, the 6.5-mm plate, and the particular shape of the haptic, which adapts to different diameters of the ciliary sulcus, are the reasons for its tridimensional stability.
In contrast to other studies,28,31 no cases of hypotony were detected. We hypothesize that the T-plug structure, by virtue of its 0.3-mm diameter and horizontal insertion, fits optimally into the 25-gauge sclerotomy as a plug. Moreover, to prevent hypotony, we tightly sutured the pars plana vitrectomy sclerotomies and corneal incisions.
Regarding late complications, we had 4 cases of cystoid macular edema (7.4%). Such an incidence is higher than that previously reported, probably because we defined its presence based on SD-OCT criteria.15 All cases were treated successfully with a single sub-Tenon's corticosteroid injection.
Two cases of haptic scleral exposure beneath the conjunctiva occurred, one in a patient with Marfan syndrome and one in an otherwise healthy patient; the only common feature was high myopia. We speculate that both conditions arose as a result of altered scleral structures32 and to manage scar retraction we preferred to suture the flaps in subsequent patients with Marfan syndrome or high myopia.32,33 Historically, surgical management of ectopia lentis was more disruptive (large sclerocorneal incisions in intracapsular cataract extraction) with a higher risk of intraoperative complications34; today less invasive options are available, such as capsular tension rings for stabilizing the bag. Although this represents a surgical alternative for managing ectopia lentis and cases of zonular weakness,33,34 it is not simple to perform. Moreover, IOLs and capsular tension rings are subject to further decentration or even dislocation in these patients because the zonular weakness is progressive. Therefore, based on our experience, a direct approach combining lensectomy with SSF-IOL implantation represents a valid alternative.33
The main limitation of the current study is the lack of a control group undergoing secondary IOL implantation with a different technique. Moreover, the follow-up was relatively short, because it was no longer than 12 months. Because complications of other techniques (eg, polypropylene suture degradation) have been observed many years after surgery, we cannot exclude that other complications may occur in the long term.
The successful use of a secondary IOL implant to manage aphakia or dislocation of an implanted IOL requires surgical experience. The SSF Carlevale IOL is a solution that combines easy, minimally invasive procedures with a good functional recovery. Given the absence of sutures, this method may represent a new option in patients with a long life expectancy (young adults).35 We speculate that it could also provide good results in a pediatric population. After an initial learning curve, this technique and the new IOL offer a stable, quick fixation as an alternative to standard procedures.
- Wagoner MD, Cox TA, Ariyasu RG, Jacobs DS, Karp CLAmerican Academy of Ophthalmology. Intraocular lens implantation in the absence of capsular support: a report by the American Academy of Ophthalmology. Ophthalmology. 2003;110(4):840–859. doi:10.1016/S0161-6420(02)02000-6 [CrossRef]
- Stem MS, Todorich B, Woodward MA, Hsu J, Wolfe JD. Scleral-fixated intraocular lenses: past and present. J Vitreoretin Dis. 2017;1(2):144–152. doi:10.1177/2474126417690650 [CrossRef]
- Kwong YY, Yuen HK, Lam RF, Lee VY, Rao SK, Lam DS. Comparison of outcomes of primary scleral-fixated versus primary anterior chamber intraocular lens implantation in complicated cataract surgeries. Ophthalmology. 2007;114(1):80–85. doi:10.1016/j.ophtha.2005.11.024 [CrossRef]
- Chan TC, Lam JK, Jhanji V, Li EY. Comparison of outcomes of primary anterior chamber versus secondary scleral-fixated intraocular lens implantation in complicated cataract surgeries. Am J Ophthalmol. 2015;159(2):221–6.e2. doi:10.1016/j.ajo.2014.10.016 [CrossRef]
- Hazar L, Kara N, Bozkurt E, Ozgurhan EB, Demirok A. Intraocular lens implantation procedures in aphakic eyes with insufficient capsular support associated with previous cataract surgery. J Refract Surg. 2013;29(10):685–691. doi:10.3928/1081597X-20130723-02 [CrossRef]
- Kim KH, Kim WS. Comparison of clinical outcomes of iris fixation and scleral fixation as treatment for intraocular lens dislocation. Am J Ophthalmol. 2015;160(3):463–469.e1. doi:10.1016/j.ajo.2015.06.010 [CrossRef]
- Dick HB, Augustin AJ. Lens implant selection with absence of capsular support. Curr Opin Ophthalmol. 2001;12(1):47–57. doi:10.1097/00055735-200102000-00009 [CrossRef]
- Por YM, Lavin MJ. Techniques of intraocular lens suspension in the absence of capsular/zonular support. Surv Ophthalmol. 2005;50(5):429–462. doi:10.1016/j.survophthal.2005.06.010 [CrossRef]
- Malbran ES, Malbran E Jr, Negri I. Lens guide suture for transport and fixation in secondary IOL implantation after intracapsular extraction. Int Ophthalmol. 1986;9(2–3):151–160. doi:10.1007/BF00159844 [CrossRef]
- Veronese C, Maiolo C, Armstrong GW, et al. New surgical approach for sutureless scleral fixation. Eur J Ophthalmol. 2020;30(3):612–615. doi:10.1177/1120672120902020 [CrossRef]
- Simpson MJ, Charman WN. The effect of testing distance on intraocular lens power calculation. J Refract Surg. 2014;30(11):726. doi:10.3928/1081597X-20141021-01 [CrossRef]
- Hoffer KJ. The Hoffer Q formula: a comparison of theoretic and regression formulas. J Cataract Refract Surg. 1993;19:700–712. Errata: 1994;20:677; 2007;33:2–3.
- Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruiz RS. A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg. 1988;14(1):17–24. doi:10.1016/S0886-3350(88)80059-2 [CrossRef]
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Indications for SSF-IOL in 54 Eyes of 50 Patients
|Indication||No. of Eyes (%)|
|Post-traumatic IOL or lens dislocation||18 (33.3%)|
|Complication of previous surgery (eg, capsular break)||17 (31.48%)|
|IOL dislocation due to pseudoexfoliation||8 (14.8%)|
|Ectopia lentis (Marfan syndrome)||5 (9.2%)|
|IOL dislocation secondary to high myopia||3 (5.5%)|
|Uveitis-glaucoma-hyphema syndrome||3 (5.5%)|
Preoperative and Postoperative Data of the 54 Eyes Analyzed
|Parameter||Mean ± SD (Range)|
|Preoperative AL (mm)||24.74 ± 2.70 (21.85 to 35.18)|
|Preoperative K (D)||43.18 ± 1.72 (38.98 to 46.95)|
|3-month K (D)||42.96 ± 1.63 (39.72 to 46.95)|
|Preoperative astigmatism (D)||1.80 ± 1.48 (0.29 to 6.97)|
|3-month astigmatism (D)||1.57 ± 1.24 (0.05 to 5.90)|
|3-month ACD (mm)||4.52 ± 0.36 (3.76 to 5.45)|
|12-month IOL tilting (°)||3.1 ± 1.1 (1 to 5.5)|