Introduction: The aim of our study was to assess the outcome of Gore-Tex sutures in minimally invasive scleral fixation of subluxated posterior chamber intraocular lenses (PCIOLs) and to demonstrate a method for validating the lens position. Methods: Retrospective study of patients who underwent lasso in-the-bag scleral fixation of a subluxated PCIOL using the snare technique with Gore-Tex suture from 2019 to 2021 in a single tertiary medical center. Functional outcome was analyzed by clinical assessment, and anatomical outcome, by ultrasound biomicroscopy (UBM). Results: A total of 18 eyes were included. The mean duration of follow-up was 140 days (range 23–659), and the median time from PCIOL implantation to fixation was 8.5 years (IQR 6.25–10.75). All patients had ocular comorbidities, mainly glaucoma (n = 6) and pseudoexfoliation syndrome (n = 5). Best corrected visual acuity improved from a median of 6/30 (0.7 logMAR) to a median of 6/12 (0.35 logMAR) (p = 0.06); postoperative astigmatism measured 0.91 ± 2.19 diopters. UBM demonstrated well-balanced PCIOL fixation with no difference between the horizontal and vertical tilt measurements (p = 0.84; p = 0.94; p = 0.62; p = 0.085). The fixated PCIOL showed <10% decentration with reference to the visual axis. There was a high negative correlation between BCVA improvement and residual lens tilt (r = −0.76, p = 0.037). Postoperative complications included transient ocular hypertension (n = 3), corneal decompensation with subsequent keratoplasty (n = 3), temporary hypotony (n = 2), cystoid macular edema (n = 1), suture exposure (n = 1), and endophthalmitis (n = 1). Conclusions: Subluxated PCIOLs are amenable to treatment with minimally invasive fixation using Gore-Tex suture with good anatomic outcomes. UBM image analysis may serve as a valuable method for assessing PCIOL position following scleral fixation.

Cataract is the cause of visual impairment in an estimated 35.1 million people worldwide [1]. Accordingly, cataract surgery is one of the most common procedures performed, with an estimated frequency of 4,000–6,000 procedures per million people per year in developed countries [2]. Approximately 0.2%–3.0% of cataract surgeries are reported to be complicated by intraocular lens (IOL) subluxation, although the actual rate may be even higher [3].

Posterior chamber intraocular lens (PCIOL) subluxation can occur within a few years to 2 decades after implantation [4]. The continuous increase in the number of cataract surgeries performed concomitant with the increase in life expectancy has led to a rising number of patients presenting with PCIOL subluxation [5, 6]. Symptoms include headaches, visual impairment, ocular pain, optical lens aberrations, and monocular diplopia. Treatment consists of lens exchange or IOL fixation to the sclera using suturing, glue, or non-glue techniques. Sutures of various materials may be used, such as 10-0 polypropylene, 8-0 polypropylene, and CV-8 polytetrafluorethylene (Gore-Tex® Suture, W. L. Gore and Associates, Flagstaff, AZ, USA) [7].

The Gore-Tex suture, a flexible, biocompatible microporous monofilament, was introduced in 1986 for cardiovascular surgeries. Numerous off-label applications have since been described [8‒10], including PCIOL scleral fixation [11]. However, few studies have examined the utility of lasso Gore-Tex suturing in the setting of a subluxated PCIOL, and even fewer have objectively assessed the resulting lens position and orientation [7].

Ultrasound biomicroscopy (UBM) generates high-resolution images of the anterior segment structures and has been widely used to evaluate PCIOL position. The aim of this study was to assess the outcome of Gore-Tex suture used for minimally invasive scleral fixation of subluxated PCIOLs and to demonstrate a method for validating the fixated lens position.

The study was approved by the Local Institutional Review Board. The electronic medical records of a tertiary university-affiliated medical center were retrospectively searched for all patients who underwent scleral fixation of a subluxated PCIOL with Gore-Tex suture between 2019 and 2021. The procedure was performed by two highly experienced surgeons (I.B., R.E.) using a similar lasso-snare technique. Patients were followed in the outpatient clinic at the discretion of the treating ophthalmologist. Postoperative subjective refractive outcomes were measured by optometrists.

Surgical Technique

A peritomy was performed at each side of the scleral fixation sites, 180 degrees apart. Thereafter, two paired marks were made on the sclera, posterior to the limbus, at 1.5 mm and 3.0 mm. After the anterior chamber was filled with a viscoelastic substance (Healon GV®, Johnson & Johnson Vision), an 8-0 Gore-Tex suture was loaded onto a 25 G needle. The needle was passed through the 3.0 mm scleral mark and under the haptic of the subluxated IOL. Using a spatula or forceps, the surgeon held the suture in place in the anterior chamber so that the needle could be retracted. Thereafter, a small paracentesis was made at the 1.5 mm scleral mark. Intraocular forceps were used to pass over the haptic and grasp the suture, looping it around the haptic and exiting at the 1.5 mm paracentesis. A knot was made and buried at the paracentesis site, and the peritomy was closed with 8/0 Vicryl sutures.

Ultrasound Biomicroscopy

An ultrasound biomicroscope (Eye Cubed™ from Ellex, Clarion Medical Technologies, Cambridge, ON, Canada) was used to evaluate the exact IOL optic and haptic positions. Nonmydriatic imaging was performed by an experienced physician using a 40 MHz transducer. Topical anesthesia was instilled with the patient in the supine position, and the optic and haptics were imaged and referred to the posterior surfaces of the overlying iris, ciliary sulcus, and corneal apex. Radial UBM sections of the horizontal and vertical images of the lens position were evaluated. Optic tilt was measured by drawing a line between the scleral spurs, marking the plane of reference for the optic position. In cases where the scleral spurs were not clearly visible, a line was drawn along the hyperreflective iris pigment epithelium layer to mark the reference plane. A second line was drawn along the anterior face of the optic, and the distance between the two lines was measured with perpendicular calipers. Additionally, a perpendicular line was drawn from the corneal apex to the optic to identify optic decentration (Fig. 1, 2). Horizontal and vertical lens tilt was measured using corresponding superior (12 clock hours), inferior (6 clock hours), medial (3 clock hours in the right eye, 9 clock hours in the left eye), and lateral (9 clock hours in the right eye, 3 clock hours in the left eye) UBM sections. The optic was considered leveled when the reference line and IOL optic were parallel. Distances were measured in millimeters, and tilt angle, in degrees.

Fig. 1.

Measurements of lens position were acquired from UBM images. a Lens decentration was measured by drawing a perpendicular line from the corneal apex to the optic. Subsequent measurements were taken from the optic circumference to the perpendicular line. b Optic tilt was measured by drawing a line between the scleral spurs, marking the plane of reference for the optic position. A second line was drawn along the anterior face of the optic, and the distance between the two lines was measured with perpendicular calipers. c Lens tilt angle was measured from the line drawn between the scleral spurs to the continual line drawn from the two optic ends.

Fig. 1.

Measurements of lens position were acquired from UBM images. a Lens decentration was measured by drawing a perpendicular line from the corneal apex to the optic. Subsequent measurements were taken from the optic circumference to the perpendicular line. b Optic tilt was measured by drawing a line between the scleral spurs, marking the plane of reference for the optic position. A second line was drawn along the anterior face of the optic, and the distance between the two lines was measured with perpendicular calipers. c Lens tilt angle was measured from the line drawn between the scleral spurs to the continual line drawn from the two optic ends.

Close modal
Fig. 2.

UBM images after posterior chamber intraocular lens (PCIOL) fixation with the minimally invasive lasso-snare technique using Gore-Tex suture. a Postoperative centered PCIOL. b Postoperative parallel PCIOL position.

Fig. 2.

UBM images after posterior chamber intraocular lens (PCIOL) fixation with the minimally invasive lasso-snare technique using Gore-Tex suture. a Postoperative centered PCIOL. b Postoperative parallel PCIOL position.

Close modal

Statistical Analysis

The chi-squared test or Fisher’s exact test, as appropriate, and Wilcoxon signed rank test were applied to analyze categorical variables, and the Mann-Whitney U test was applied for continuous variables. Spearman’s rank correlation test was used to evaluate single correlations between variables. All statistical analyses were two-sided, and significance was set at a p value of 0.05. Data were generated with Prism 7.0 (GraphPad Software, San Diego, CA, USA) and R 3.4.2 (R Foundation for Statistical Computing, Vienna, Austria).

Eighteen patients (18 eyes) were included in the study. Their characteristics are summarized in Table 1. The median time from PCIOL implantation to fixation was 8.5 years (IQR 6.25–10.75 years), and the mean duration of follow-up from PCIOL fixation was 140 days (range 23–659 days). All patients presented with a subluxated PCIOL, and all had preexisting systemic and ocular comorbidities, as follows: hypertension (n = 15), dyslipidemia (n = 9), diabetes mellitus (n = 9), and ischemic heart disease (n = 6); glaucoma (n = 6), pseudoexfoliation syndrome (n = 5), age-related macular degeneration (n = 3), high myopia (n = 2), macular scar (n = 1), and previous penetrating keratoplasty (n = 1).

Table 1.

Baseline characteristics of 18 patients with subluxated PCIOL

CharacteristicsValue
Age, mean±SD, years 79.3±9.0 
Gender – female, n (%) 9 (50) 
Time from PCIOL implantation, median (IQR), years 8.5 (6.25–10.75) 
Eye – right, n (%) 9 (50) 
Follow-up, median (IQR), days 140 (39–146) 
Systemic comorbidities, n (%) 
 Hypertension 15 (83.3) 
 Dyslipidemia 9 (50) 
 Diabetes 9 (50) 
 Ischemic heart disease 6 (33.3) 
Ophthalmic comorbidities, n (%) 
 Glaucoma 6 (33.3) 
 Age-related macular degeneration 3 (16.6) 
 Pseudoexfoliation syndrome 5 (27.7) 
 Myopia 2 (11.1) 
 Macular scar 1 (5.5) 
 Corneal transplantation 1 (5.5) 
CharacteristicsValue
Age, mean±SD, years 79.3±9.0 
Gender – female, n (%) 9 (50) 
Time from PCIOL implantation, median (IQR), years 8.5 (6.25–10.75) 
Eye – right, n (%) 9 (50) 
Follow-up, median (IQR), days 140 (39–146) 
Systemic comorbidities, n (%) 
 Hypertension 15 (83.3) 
 Dyslipidemia 9 (50) 
 Diabetes 9 (50) 
 Ischemic heart disease 6 (33.3) 
Ophthalmic comorbidities, n (%) 
 Glaucoma 6 (33.3) 
 Age-related macular degeneration 3 (16.6) 
 Pseudoexfoliation syndrome 5 (27.7) 
 Myopia 2 (11.1) 
 Macular scar 1 (5.5) 
 Corneal transplantation 1 (5.5) 

In 3 patients, PCIOL fixation was performed as a combined surgery with either Descemet’s stripping automated endothelial keratoplasty (DSAEK) (n = 2) or cyclophotocoagulation laser (n = 1). Anterior vitrectomy was performed in 6 (33%) patients. Pars plana vitrectomy was not required in these patients for PCIOL fixation.

The median BCVA improved from 6/30 (0.7, IQR 0.28–1.4 logMAR) at presentation to 6/76 (1.08 IQR 0.54–2.0 logMAR) 1 day after PCIOL fixation and to 6/12 (0.3 IQR 0.2–0.7 logMAR) at the last follow-up visit. The differences between the preoperative and day 1 values and between the day 1 and last follow-up values were statistically significant (p = 0.06 and p < 0.0009, respectively).

Image analysis with UBM was used to gauge the tilt of the fixated PCIOL. The median distance from the reference line drawn between the scleral spurs on the horizontal image was 1.56 mm (IQR 1.26–1.82 mm) at the medial position and 1.62 mm (IQR 1.24–2.03 mm) at the lateral position (p = 0.375). The absolute difference between the two sides was 0.68 mm (IQR 0.16–0.96 mm). On the vertical image, the superior position measured 1.48 mm (IQR 1.15–1.77 mm), and the inferior position, 1.45 mm (IQR 1.12–1.7 mm) (p = 0.637), with an absolute difference of 0.77 mm (IQR 0.18–0.77). There was no significant difference between the overall horizontal and vertical tilt measurements (medial vs superior, p = 0.84; medial vs inferior, p = 0.94; lateral vs superior, p = 0.62; lateral vs inferior, p = 0.085) or in the tilt angle formed in the horizontal image (median 4.3 degrees, IQR 0.92–7.3) and the vertical image (3.05 degrees, IQR 1.56–7.27, p = 0.625). The maximal measured tilt angle on any plane was 9.56 degrees.

Measurement of the magnitude of PCIOL decentration showed that the fixated PCIOL was decentered by a median of 0.02 mm (IQR 0–0.33 mm) on the horizontal image and a median of 0.1 mm (IQR 0–0.28 mm) on the vertical image (p = 0.94). The percent decentration on the horizontal image was positively correlated to the vertical distance from the reference plane to the optic on medial tilt measurement (r = 0.82, p = 0.005), and on the vertical image, to the superior position tilt measurement (r = 0.912, p = 0.001). The median anterior chamber depth was 3.52 mm (IQR 3.0–4.11 mm).

There was a negative correlation of the improvement in BCVA with the tilt of the fixated PCIOL on the vertical image (r = −0.762, p = 0.037) but not on the horizontal image (p = 0.337). The median postoperative spherical equivalent (SEQ) was 0 (IQR −3.3–0.625 diopters), and the median postoperative astigmatism was 0.91 ± 2.19 diopters. The median postoperative axis was 4.94 degrees. There was a positive correlation between the postoperative astigmatism and the last BCVA (r = 0.764, p = 0.033). Postoperative complications included transient ocular hypertension in 3 eyes, temporary hypotony in 2, corneal decompensation with subsequent DSAEK in 3, and central macular edema, suture exposure, and endophthalmitis in 1 eye each.

We present a minimally invasive method for fixating a subluxated PCIOL with the Gore-Tex suture. In prior studies that addressed the use of Gore-Tex sutures for IOL fixation, the procedure was combined with pars plana vitrectomy and the focus was on the outcomes of secondary IOL implantation surgeries [12‒14].

The use of a small-scale needle (25 G) in our minimally invasive method eliminated the need for trocars or large corneal incisions, in contrast to previous studies [11, 14, 15]. In addition, to assess the postoperative PCIOL position, we used UBM which allowed visualization of structures posterior to the iris. The biomicroscope is portable and maneuverable and can be used intraoperatively as well [16]. The results showed a well-balanced, fixated IOL, with no differences in measurements at any position of the IOL (p = 0.375; p = 0.637; p = 0.84; p = 0.94; p = 0.62; p = 0.085). In contrast to the work of Loya et al. [17] and Kumar et al. [18, 19], who took the iris as the reference plane when evaluating IOL tilt using UBM, we drew a straight line passing through the iridocorneal angles as a reference, similar to the procedure described by Yamane et al. [20] and Zhao et al. [21] This overcomes the possible nonsymmetrical iris characteristic of eyes that have undergone surgery which can lead to inaccurate PCIOL assessment. Moreover, we did not dilate the pupil prior to UBM examination to allow for a more accurate analysis of the iris in relation to the PCIOL [22]. An additional important modality that can be beneficial for IOL position assessment is the anterior segment OCT, which has high measurement reproducibility and superior resolution [16, 20]. However, optimal representation of the IOL position using anterior segment OCT requires maximal pupil dilation with a limited view of the IOL’s haptics to the ciliary body.”

On UBM analysis, the median PCIOL tilt angle was 4.3 degrees (IQR 0.92–7.3) measured horizontally and 3.05 degrees (IQR 1.56–7.27) measured vertically. These results are similar to those reported by Wang et al. [23] in a study of 333 patients with uneventful in-the-bag PCIOL fixation. For scleral fixation, both Kemer Atik et al. [22] and Hayashi et al. [24] used a 10-0 polypropylene suture as a primary procedure on a pre-implanted IOL, with different results; neither study, as opposed to ours, addressed fixation of the subluxated PCIOL whiteout exchanging the lens nor implanting a new one. Kemer Atik et al. [22] reported a mean tilt angle of 3.8 ± 4.09 degrees on the horizontal plane and 2.83 ± 4.03 degrees on the vertical plane. Hayashi et al. [24] observed a higher mean tilt angle of 6.35 ± 3.09 degrees. Furthermore, the tilt angle was 10 degrees or more on the horizontal axis in 6.4% of patients and on the vertical axis in 7.4% of patients. By contrast, in none of our patients did the angle exceed 10 degrees on any plane. Our results demonstrate that the Gore-Tex suture procedure is not inferior to in-the-bag IOL or scleral fixation in terms of the lens tilt angle and had less variability.

The second outcome evaluated by UBM was lens decentration. The fixated IOL was found to be highly centered with less than 10% decentration in both the horizontal image (median 7.32%, IQR 0.925–15.47%) and the vertical image (median 6.69%, IQR 3.99–13.6%), with no significant difference among the sections (p = 0.94). Hayashi et al. [24] reported decentration in millimeters rather than percentages from the principal axis, which may not fully portray tiny amounts of decentration due to the small scale of the measurements. Nevertheless, compared to in-the-bag fixation with a 10-0 polypropylene suture [24], the amount of decentration with the Gore-Tex suture was smaller by 0.29 ± 0.21 mm. This finding may contribute to the validity of the Gore-Tex suture surgical approach. Furthermore, the assessment of decentration on the vertical and horizontal axes is more feasible than the Scheimpflug technique reported by Sasaki et al. [25].

The third outcome evaluated by UBM was anterior chamber depth, determined by the position of the fixated PCIOL which has an important impact on postoperative refraction as well as the occurrence of complications such as uveitis-glaucoma-hyphema syndrome. The median post-fixation anterior chamber depth in our study was 3.52 mm (IQR 3.0–4.1 mm), similar to that reported for in-the-bag PCIOL (3.61–4.06 mm) [26‒28]. That our patients were managed without combined pars plana vitrectomy may account for this optimal result, providing additional support for the decision to use the minimally invasive lasso-snare technique with Gore-Tex suture.

Besides the anatomical outcome, functional analysis yielded a median early postoperative BCVA of 6/30 which improved at the last follow-up visit to 6/12 (p = 0.06). These results are similar to those of Su et al. [13] (at 3-month follow-up mean of 0.49 ± 0.52 LogMAR; Snellen equivalent, 20/62), who investigated the refractive outcome of combined pars plana vitrectomy and scleral fixation of a newly implanted IOL using Gore-Tex suture. This is important given that, unlike Su et al. [13], we studied patients with a subluxated PCIOL and all of them also had multiple preexisting ophthalmic comorbidities. In the earlier study, the IOL was implanted and fixated 2 mm posterior to the limbus in 14 eyes and 3 mm posterior to the limbus in 41 eyes, and both groups exhibited a myopic shift. The mean respective postoperative SEQ values were −1.53 ± 1.35 and −0.82 ± 0.83 diopters. Botsford et al. [15] reviewed the refractive outcomes of IOL implantation using Gore-Tex suture combined with pars plana vitrectomy in 31 patients. The IOL was fixated in the sclera, 3 mm posterior to the limbus. The average predictive error was −0.19 ± 0.72 diopters, suggesting a slight myopic shift. In contrast, Ohr et al. [29], in a study of 20 patients who underwent scleral fixation of secondary IOL implantation, reported a mean deviation in SEQ of 0.16 ± 0.69 diopters, suggesting a slight hyperopic error. In the present study, we did not find a hyperopic shift. The median postoperative SEQ was 0 with an IQR of −3.3 to 0.625 diopters. The SEQ range may suggest a myopic tendency, as in the studies of Su et al. [13] and Botsford et al. [15] As we fixated the PCIOL to the sclera in a radial manner at 1.5 mm and 3 mm posterior to the limbus, our results may suggest that the 3 mm posterior fixation is associated with a better postoperative SEQ [13, 30].

In our cohort, the median postoperative astigmatism measured 0.91 ± 2.19 diopters, similar to previous reports on IOL fixation without tilt [22]. As expected, the postoperative astigmatism was positively correlated with the last registered BCVA (r = 0.764, p = 0.033). This good astigmatism outcome should encourage ophthalmologists to use the minimally invasive lasso-snare technique.

The most common postoperative complications were transient ocular hypertension and corneal decompensation warranting DSAEK transplantation in 3 eyes with 2 of them having prior corneal transplant. Other complications included transient hypotony in 2 eyes, which resolved in 24 h, and central macular edema, suture exposure, and endophthalmitis in 1 eye each. The minor complications were similar to those reported by Khan et al. [12] for scleral fixation using Gore-Tex suture during PCIOL implantation, and by Botsford et al. [15]. The inclusion of patients with preexisting ocular comorbidities could have led to a higher rate of complications. The suture exposure occurred in a patient who underwent a combined procedure with cyclophotocoagulation laser, which by itself may lead to this complication due to scleral instability [31]. Patel et al. [32] reported Gore-Tex suture exposure in a patient with retinal detachment and high myopia treated with 4-point scleral fixation that was complicated by infectious scleritis at 6 months. The authors concluded that prior surgical manipulation may have contributed to the scleral vulnerability at the suture site. Therefore, clinicians should consider the possibility of scleral vulnerability due to previous or additional surgical treatment when selecting patients for snare-type PCIOL fixation with Gore-Tex suture. Additionally, the need for post-fixation DSAEK in 3 of our patients should prompt clinicians to take preexisting ophthalmic comorbidities into account. One of the 3 patients had undergone penetrating keratoplasty prior to PCIOL fixation, and another was diagnosed with a pseudophakic bullous keratopathy and therefore underwent combined PCIOL fixation and DSAEK, with the second DSAEK performed later. The third patient had endophthalmitis, which can occur in any ocular surgical procedure [7, 33, 34].

Our study has several limitations. First, we used a retrospective design which has inherent biases. Second, all procedures were performed by two skilled surgeons in complicated cases; therefore, these postoperative outcomes might not be generalizable to procedures performed by less experienced surgeons. Nevertheless, the proposed minimally invasive snare technique is simple to understand and perform, suggesting a steep learning curve. Third, this was a small study conducted in a single major medical center, and postoperative outcomes and complications may differ with a larger sample size and may limit the generalizability of the findings. Finally, as we used real-world data, all patients had preexisting ophthalmic comorbidities, and preoperative SEQ and astigmatism values were not available owing to the unpredictable nature of PCIOL subluxation. In addition, due to the patients’ variable BCVA, the ability to correctly assess refraction is limited.

In summary, the minimally invasive lasso-snare technique using Gore-Tex suture in patients with a subluxated PCIOL yielded very good anatomical results in terms of lens tilt and centration. Image analysis with UBM may serve an important tool in this setting to facilitate localization of the fixated PCIOLs and warrants further study on its intraoperative utility.

The study was approved by the Local Institutional Review Board (IRB) in the Rabin Medical Center, Approval No. 503-19-RMC. Due to the study’s retrospective nature, the need for consent form was waivered by the IRB.

None of the authors have any financial/conflicting interests to disclose.

No funding was provided to any of the authors in this study.

A.T., R.S., I.B., and R.E. conceptualized the study. I.B. and R.E. performed the surgeries. A.T. collected and analyzed the data. O.G.-O. conducted the UBM. A.T., I.B., R.E., R.S., O.G.-O., and R.Z. participated in drafting of the study and reviewed the manuscript.

All data generated or analyzed during this study are included in this article. Further inquiries can be directed to the corresponding author.

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