Comparison of iris sutured versus trocar-assisted sutureless scleral fixation techniques for dislocated one-piece and three-piece intraocular lenses

Abstract

Purpose: To explore the visual outcome and complications of iris sutured intraocular lenses (ISIOLs) and sutureless scleral-fixated intraocular lenses (SSIOLs) in the surgical management of patients without exchanging dislocated posterior chamber intraocular lenses (PCIOLs) into the vitreous.

Methods: Fourteen ISIOLs and 15 SSIOLs implantations for dislocated PCIOLs were analyzed retrospectively. Mean follow-up of ISIOL Group and SSIOL Group: 11,3 ± 2, 0 (range: 9-15) months and 11, 8± 2, 2 (range: 9-16) months, respectively Preoperative and postoperative outcomes, operative indications, and complications were evaluated.

Results: Primary surgical indications were pseudoexfoliation (PXE) (21,4 %), post-cataract surgery (PCS) (35,7 %) trauma (42,8 %), in ISIOL group and PXE (26,6 %), PCS (40 %) trauma (33,3 %) in SSIOL group, respectively. At latest follow-up, there was improvement in best-corrected visual acuity (BCVA) (0.053 ± 0.051 to 0.53 ± 0.13 p <0.0001) in ISIOL group and (0.05± 0, 02 to 0.64± 0, 16, p <0.0001) in SSIOL group. Postoperative complications of ISIOL group and SSIOL group included corneal oedema (14,2%; nil), IOP elevation (21,4%;7,1 %), bullous keratopathy (14,2%;nil), anterior uveitis (35,7%;13,3%), cystoid macular oedema (CME) (21,4%);7,1%), pupil ovalization (21,4%;nil), broken haptic (none; 13,3%), IOL exchange (nil; 13,3%), and vitreous haemorrhage (nil; 14,2%).

Conclusions: Self-IOL implantation may enable much earlier visual rehabilitation in the SISIOL group than the IFIOL group. Moreover, the 27G trocar-assisted SSIOL technique takes a shorter operation time and relatively lower complication rates. Further studies with larger series and longer follow-up assessments are required.

Introduction

Visual rehabilitation of aphakic eyes varies from traditional approaches to new surgical interventions, such as epikeratophakia, angle-fixated anterior chamber (AC) intraocular lens (IOL) implant, iris-claw IOL implant, iris-fixated posterior chamber (PC) IOL implant, or a scleral-sutured or -glued PC IOL implant and sutureless fixation of a 3-piece IOL to the sclera [1–3].

Although phacoemulsification and femtosecond laser technology has improved considerably, in- or out-of-the-bag PCIOL dislocations are still encountered. IOL decentration or dislocations occur in approximately 2–3% of cases following cataract surgeries [4]. IOL dislocations frequently evolve within three months due to traumatic zonular or capsular rupture.

Predisposing factors include trauma, pseudoexfoliation (PXE), uveitis, asymmetric implantation of IOL haptic, previous vitrectomy surgery. PXE accounts for over 50% of cases of late IOL dislocation, a complication that is estimated to occur in 7% of post-cataract surgery patients after 25 years [5].

A well-known approach to address dropped PCIOLs is to perform vitrectomy, extract them out of the anterior chamber (AC), and replace it with ACIOL, scleral fixated (SF) IOL, or iris-claw (IC) IOL. The technique for iris-sutured IOL was first described by McCannel in 1976 and refined with the Siepser slipknot [6, 7]. This technique allows for small corneal incisions with foldable three-piece IOLs. In this study, we performed an iris sutured (IS) technique ( McCannel) for dislocated foldable one-piece PCIOL and sutureless scleral fixation (SS) technique (trocar-assisted) for dislocated foldable 3-piece-PCIOLs. This study is the first clinical study to compare the efficacy and safety of the iris sutured technique and the 27G sutureless scleral fixation technique for the dislocated IOLs into vitreous.

Methods

This cross-sectional, retrospective cohort study was performed using15 eyes of 15 patients who underwent the SISFIOL technique, and 14 eyes of 14 patients who underwent the IFIOL technique for the dislocated PCIOLs from 2017 to 2021 with a minimum of 9 months-follow‑up were included in the study at Izmir Katip Celebi University, Ataturk Training and Research Hospital Eye Clinic. Patients were excluded if they underwent surgery at less than 18 years of age, the follow-up the period was less than six months, corneal scar glaucoma, macular scar. The study was performed in accordance with the Declaration of Helsinki. Written informed consent to participate in the study was obtained from all individuals.

Iris fixation of IOLs had been performed on 14 patients if there was dislocated one-piece foldable and the iris support adequately. Various reasons for IOLdislocation into the vitreous cavity were included. The follow-up time of patients was for a mean of 11,3 ± 2, 0 (range: 9–15) months. The SSFIOL group consisted of 15 patients with dislocated three-piece foldable IOL. The follow-up time of patients was for a mean of 11,8 ± 2,2 (range: 9–16) months. IOLhaptics of two patients also had distorted or broken during the operation and been switched with new IOL (Eyecryl plus TP6130® Biotech Vision care, Ptv., Ltd. Ahmedabad, Gujarat, India). Refractive error was determined with an auto refractometer (Auto Ref/ keratometry ARK-1s Nidek co., Ltd. Japan). All patient charts were reviewed for functional and anatomical outcomes in detail baseline demographic, ocular, and systemic characteristics of all patients are demonstrated in Table 1. 

Surgical Techniques

All surgeries were performed under peribulbar anesthesia by a single surgeon (EA). A complete 23-gauge three-port pars plana vitrectomy (Dorc Eva, DORC B.V, Kerkweg 47e, 3214 VC Zuidland, Netherlands) was performed, removing the posterior hyaloid and with enough vitreous to free the dislocated PCIOLs from its vitreous attachments. Perfluorocarbon liquid (perfluoro-decline)was introduced in the vitreous cavity to maintain a bubble under the lens and to ensure it floats outwards out of the macular area. At this time, a dispersive ophthalmic viscosurgical device (OVD) is introduced into the anterior chamber. Firstly, the dropped PCIOLswere removed from the bag complex in the center of the vitreous (Fig. 1a). The haptics of PCIOLs was grasped by serrated micro forceps and taken into the anterior chamber with support of the endoilumination pipe (Fig. 1b). If the pupil is dilated, MIOSTAT (Alcon % 0.01,0.1–0.2 ml) can be injected to make it constricted. After optical capture of PCIOL, one of the haptics should be placed beneath the iris at three and 9 o'clock, and corneal paracentesis should be made at the same quadrants (Fig. 1c). The reduced infusion flow causes anterior elevation of the IOL, bringing it closer to the posterior iris. The stitches are thrown using the modified Mc Cannel technique (single-armed 10 − 0 polypropylene CIF-4 or CTC-6L (loop)needle (Ethicon, Inc., Somerville, NJ) that should pass widely around both haptics (6)(Fig. 1d). Both ends of the stitches are gently pulled to check for movement of the IOL, then tied (Fig. 1e) and trimmed by removing out through a subsequent limbal paracentesis incision with a hook (Fig. 1f).

The SSFIOL technique was used as described by Yamane et al. [10] and modified with 27G trocars in our usage. After performing a 23-gauge three-port pars plana vitrectomy (Dorc Eva, DORC B.V, Kerkweg 47e, 3214 VC Zuidland, The Netherlands), the haptics of PCIOLs was grasped by serrated micro forceps and taken into the anterior chamber with support of the endoilimunation pipe (Fig. 2a, and b). Then, the transconjunctival scleral tunnels were prepared with 15-degree angulation using a 27-gauge trocar at the 2:30 − 03:00 and 8:30-09:00 positions 2 mm away from the surgical limbus (Fig. 2c). The first haptic was pushed into the lumen of 27 G trocar with 27G serrated forceps (DORC B.V., Kerkweg 47e, 3214 VC Zuidland, The Netherlands) and the first haptic was externalized at 03:00 by sliding up the cannula of 27 G trocar (Fig. 2d). A terminal knob was formed by flanging the haptic with a battery-operated thermal cautery unit (Bovie Low-Temperature Cautery Fine Tip, Purchase, NY) (Fig. 2e). The created knob was pushed and fixed into the scleral tunnel. The same procedure was performed for the second haptic at the 8:30 position (Fig. 2f). Yamani technique was modified with a 27 G trocar system for dropped PCIOL. After implantation of the IOL, the corneal incision was hydrated with the balanced salt solution following intracameral viscoelastic removal.

Statistics

All statistical analyses were performed using SPSS version 18.0 (SPSS Inc, Chicago, Illinois, USA). The distribution of the continuous variables was determined by the Kolmogorov–Smirnov test. Continuous variables were compared using independent t-tests, Wilcoxon signed-rank tests, and Mann- Whitney U tests, and categorical variables were compared using Pearsonx2 tests. P < 0.05 was considered statistically significant.

Results

During the study period, 14 patients and 15 patients underwent ISIOL implantation and SSIOL implantation at our Eye Clinic. There were no significant differences in age, gender, and laterality between the ISIOL and SSIOL groups (P >.05 each, Table 1). Mean operation-time in the scleral and iris fixation groups was 2.8±1.4 (1-5) weeks and 2,3± 1.2 (1-5) weeks, respectively.

Visual acuity was significantly improved after surgery in both groups. Best-corrected distance visual acuity. (BCVA) was preoperatively and 0.053 ± 0.051 to 0.53 ± 0.13 (p <0.0001) in ISIOL group and 0.05± 0, 02 to 0.64± 0, 16, (p <0.0001) in IFIOL and SSIOL groups, respectively. The change from mean preoperative BCVA to 9^th month of postoperative BCVA was significant in both groups (P<0.05) (Figure 1).

Postoperative refractive errors were remarkably higher in the ISIOL group than in the SSIOL group (p= 0.001). The operation time was significantly shorter in the SSIOL group than in the IFIOL group (P<0.05) (Table 1).

Any serious complications such as dislocation IOL, retinal detachment, and suprachoroidal hemorrage were not observed during the surgeries. Postoperative complications of ISIOL group and SSIOL group included corneal oedema (14,2%; nil), IOP elevation (21,4%;7,1 %), bullous keratopathy (14,2%;nil), anterior uveitis (35,7%;13,3%), cystoid macular oedema (CME) (21,4%);7,1%), pupil ovalization (21,4%;nil), broken haptic (none; 13,3%), IOL exchange (nil; 13,3%), and vitreous haemorrhage (nil; 14,2%) (Table 2). However, postoperative uveitis  after surgery was more severe in the ISIOL group than in the SSIOL group. Intraocular pressure (IOP) tended to be higher in IFIOL than in the SSIOL group at the first month (P > 0.05); the difference was significant. The mean changes from preoperative IOP were 15, 5±1, 2 in the SSFIOL group and 14.7±1.1 in the IFIOL group (P > 0.05) (Figure 2).

Table 2.  Postoperative complications in the IFIOL group and SFIOL group.

IOP: intraocular pressure, IOL: intraocular lens

*IOLs exchange were done due to broken/distorted IOL haptics in the SSFIOL group

Discussion

The first sutureless scleral fixation IOL implantation was described by Gabor and Pavlidis [8,9]. Minor trauma decreased IOL tilt incidence, and better IOL stabilization was defined by this technique [9]. Agarwal et al. attached IOL haptics with tissue adhesives to limbal-based scleral flap in 53 cases without posterior capsule support and reported cystoid macular edema (7.5%), IOL decentralization (5.6%), pigment dispersion (3.7%), and hyphema (3.7%) [10] Yamane et al. [11] described a novel approach that intrascleral fixation of IOL haptics is made transconjunctivally. They reported that IOL-iris capture (8%), vitreous hemorrhage (5%), hypotonia (2%), increased intraocular pressure (2%), transient corneal edema (1%), and cystoid macular edema (1%). IOL fixation is maintained very well, and less operation time is required via a minimally invasive technique. Trocar-assisted sutureless scleral fixation of IOL (SSIOL) with pars plana vitrectomy (PPV) has been described [12-15]. Furthermore, it was demonstrated to have favorable anatomical and visual outcomes [16,17]. Compared with previous studies, we included only eyes with dropped foldable PCIOL and evaluated ISIOL Group and SSIOL Group in our research comparatively.

In our study, while both surgical techniques significantly improved visual acuity along 9 months, remarkable changes were superior in the SSIOL group than the IFIOL group within the first month. BCVA was over 0.3 in 71 % of the ISIOL group and 80 % of the SSFIOL group. BCVA was over 0.5 in %50 of the ISIOL group and %86 of SSFIOL group in the 9^th month. During iris fixation surgery, penetrating the iris with a needle could damage its capillary structure and cause hemorrhages or iridodialysis. On the other hand, IOL haptics may rub against the pigment epithelium of the iris, releasing pigments. These pigments could evolve inflammatory reactions that may prevent vision improvement in the iris fixation group. Moreover, IOP tended to be higher in the iris fixation group within the first month. The grade of AC flare also tended to be higher in the iris fixation group, but the difference was not statistically significant.

Madhivanan et al. showed that iris-claw IOLs had delayed visual recovery at one month. They attributed this to delayed wound healing in the iris-claw group in which IOL implantation was performed as a primary procedure. We also observed more corneal and retinal pathology in the ISIOL group than in the SSIOL group, similar to the study of Madhivanan et al. [18].

Postoperative spherical refractive errors were significantly higher in the ISIOL group than in the SSIOL group. A hypermetropic shift in the ISIOL group may be seen owing to progressive iris stromal thinning resulting from loosening sutures [14]. On the other hand, being placed far from the nodal point of the lens might be another reason. When comparing complications in both groups, we found that IOP tended to be higher in the ISIOL group, peaking during the first week after surgery. IOP in this group was likely related to extravasation and inflammation, potentially more prevalent in the ISIOL group.

The limitations of this study are the retrospective nature and the number of cases. It was not possible to compare preoperative and postoperative refractive changes. Nevertheless, this study is the first to compare the efficacy and safety of iris sutured and 27G sutureless scleral fixation techniques for the dropped IOLs into vitreous. The retrospective nature of this study and the performance of the procedures at a referral hospital limited knowledge about the type of IOL, precluding IOL type from being incorporated into the analysis. It is noteworthy that the present study compared outcomes for fixation techniques for surgical repositioning of dislocated intraocular lenses in a closed system, which was managed without exchanging new PCIOL except for two patients in the SFIOL group. Sutureless scleral procedures were performed to repose dropped IOLs with rigid haptics, but iris suturing techniques were done with soft haptics. Postoperatively, rigid blue haptic of sutureless scleral would present irritation and itching at times.

Prospective studies are needed to assess the AC flare degree between both techniques and whether the type of dislocated IOL could have an effect on the surgical results. In summary, lens positioning of the SSIOL group is closer to the physiological nodal point of the eye and provided better postoperative axial stability and fewer refraction changes than the ISIOL group. Compared to ISIOLs, SSIOLs are further away from the anterior chamber that avoids potential complications such as corneal edema, peripheral anterior synechiae, glaucoma [19].

The ISIOL and SSIOL techniques for the repositioning of dislocated IOL showed similar efficacy. The advantage of these procedures is using the same IOL in a closed-eye system without large corneal incisions and astigmatic changes. The ISIOL technique had several drawbacks, such as taking much more time, increased postoperative inflammation, and more refraction that is hypermetropic. The SSIOL technique via 27G trocar has the advantage of the shorter operation time, fewer complications, and better positioning of IOL.

Declarations

Authors contributions Study conception and design (EA), acquisition of data (LK), analysis and interpretation of data (EA, LK), drafting of the manuscript (EA, LK), critical revision (EA).

Funding This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Data availability Data are available on reasonable request from the authors. 

Conflict of interest The authors declare that they do not have any conflict of interest.

Consent to publish All authors read and approved the final version of the manuscript

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