Ophthalmic Surgery, Lasers and Imaging Retina

Clinical Science 

Single-Haptic Dislocation of Retropupillary Iris-Claw Intraocular Lens: Outcomes of Reenclavation

Min Seok Kim, MD, MSc; Sang Jun Park, MD, MSc; Kwangsic Joo, MD, PhD; Hyun Goo Kang, MD; Min Kim, MD; Se Joon Woo, MD, PhD

Abstract

BACKGROUND AND OBJECTIVE:

To report the clinical feature of dislocated retropupillary iris-claw aphakic intraocular lens (IOL) and outcomes of reenclavation.

PATIENTS AND METHODS:

In this multicenter, retrospective case series, 225 eyes of 225 patients underwent retropupillary fixation of iris-claw aphakic IOL and the cases with haptic dislocation were reviewed.

RESULTS:

Single haptic dislocation was observed in 22 of 225 eyes (9.8%) after 89 ± 77 days (range: 5 days to 277 days) postoperatively, and resolution was achieved through reenclavation without any intraoperative complications in all patients. Iris atrophy in 13 eyes (59%) and history of face washing at the time of dislocation in five patients (23%) were noted. Reenclavation did not cause statistically significant change in best-corrected visual acuity (P = .315), spherical equivalent (P = .660), or endothelial cell count (P = .182) compared to those after the primary surgery.

CONCLUSION:

Single-haptic dislocation of retropupillary iris-claw aphakic IOL is not a rare complication and can be safely and effectively corrected by reenclavation.

[Ophthalmic Surg Lasers Imaging Retina. 2020;51:384–390.]

Abstract

BACKGROUND AND OBJECTIVE:

To report the clinical feature of dislocated retropupillary iris-claw aphakic intraocular lens (IOL) and outcomes of reenclavation.

PATIENTS AND METHODS:

In this multicenter, retrospective case series, 225 eyes of 225 patients underwent retropupillary fixation of iris-claw aphakic IOL and the cases with haptic dislocation were reviewed.

RESULTS:

Single haptic dislocation was observed in 22 of 225 eyes (9.8%) after 89 ± 77 days (range: 5 days to 277 days) postoperatively, and resolution was achieved through reenclavation without any intraoperative complications in all patients. Iris atrophy in 13 eyes (59%) and history of face washing at the time of dislocation in five patients (23%) were noted. Reenclavation did not cause statistically significant change in best-corrected visual acuity (P = .315), spherical equivalent (P = .660), or endothelial cell count (P = .182) compared to those after the primary surgery.

CONCLUSION:

Single-haptic dislocation of retropupillary iris-claw aphakic IOL is not a rare complication and can be safely and effectively corrected by reenclavation.

[Ophthalmic Surg Lasers Imaging Retina. 2020;51:384–390.]

Introduction

Advancements in surgical techniques have enabled surgical corrections for aphakia or inadequate capsular support of the lens, which include sutured scleral fixation,1–3 angle-supported anterior chamber fixation,4 and iris fixation.5,6

Among them, iris-claw intraocular lens (IOL), which has two clips on both sides of the optic for iris capture, is widely used for secondary IOL implantation through a process called enclavation. The knuckles of the iris secure the lens optic parallel to the plane of the iris.7 The first iris-claw IOL was designed for fixating above the iris plane, whereas one of the latest versions for the aphakic eye is via the retropupillary implantation technique.8,9 Low endothelial cell loss is considered to be one of the major advantages of retropupillary fixation over anterior fixation.10

Iris-claw IOL is widely used, and several studies have reported associated intraoperative and postoperative complications.9,11–15 Reports have indicated that dislocation of the IOL secondary to trauma or spontaneous release is one of the possible complications of iris-claw IOL, which requires surgical revision by reenclavation or scleral fixation.16–18 The dislocation rate of posterior iris-claw IOL was between 0% and 10%;6,10–12 insufficient tissue grasping and trauma were the pre-disposing factors of IOL dislocation.16,17 Successful reenclavation of subluxated iris-claw phakic IOL to the anterior surface of the iris has been reported without significant adverse effect.17,18 However, the clinical feature and outcomes as well as risk factors of reenclavation of retropupillary iris-fixated aphakic IOL have not been evaluated thoroughly in large numbers.

In this study, we evaluated 22 eyes with dislocated retropupillary iris-claw aphakic IOL that underwent successful reenclavation and reported the patient outcomes.

Patients and Methods

This study was approved by the Institutional Review Board of Seoul National University Bundang Hospital (B-1902-520-108) and Yonsei University Gangnam Severance Hospital (3-2019-0126) and was conducted in accordance with the tenets of the Declaration of Helsinki. The requirement for informed consent was waived by the respective Institutional Review Boards owing to the retrospective nature of the study.

A total of 225 patients (225 eyes) underwent retropupillary fixation of the Artisan aphakia iris-claw lens (Ophtec, Groningen, Netherlands) between March 2018 and May 2019 at Seoul National University Bundang Hospital by three surgeons (SJW, KJ, SJP), and between September 2014 and September 2018 at Yonsei University Gangnam Severance Hospital by one surgeon (MK). Among these patients, 22 eyes of 22 patients were cases of dislocation of the haptic and reenclavation surgery was performed for each case. For the 22 patients, retrospective chart review was performed. Perioperative data were obtained including demographics, cause of primary and secondary surgery, characteristic feature of disenclavation, and duration until dislocation.

In pre- and postoperative evaluation, measurement of the best-corrected visual acuity (BCVA), refractive error in spherical equivalents (SE), specular microscopy (Noncon Robo SP-8000 noncontact specular microscope; Konan, Hyogo, Japan) of the corneal endothelium, slit-lamp examination, tonometry, and fundus examination were performed.

Statistical Analysis

Statistical analysis was performed using SPSS Version 25.0 (IBM Corp., Armonk, NY). Comparison of measurement values at different time points was carried out using the Wilcoxon signed-rank test.

Surgical Technique

All surgeons performed identical procedures. For initial implantation of the retropupillary iris-claw IOL, general or sub-Tenon's anesthesia was done based on patient's demand and surgeon's preference. In all cases, 25-gauge standard three-port pars plana vitrectomy and removal of any dislocated lens present was performed. Two side port incisions were made at 2-o'clock and 10-o'clock positions, and a 5.5-mm wide corneo-scleral tunnel was made at the 12-o'clock position. After intracameral injection of carbachol 0.01% (MIOSTAT; Alcon, Fort Worth, TX), a viscoelastic device (Healon; Johnson & Johnson Vision, Santa Ana, CA, or Unial; Unimed Pharm., Seoul, Korea) was placed into the anterior chamber. The Artisan aphakia lens was inserted through the corneo-scleral tunnel upside-down and rotated with a hook so that the haptics were positioned at 3-o'clock and 9-o'clock centered over the pupil. Two temporary 10-0 nylon sutures were placed at the corneo-scleral tunnel to prevent leakage of the visco-elastic device intraprocedurally. The IOL, held with a lens fixation forceps, was slipped through the pupillary area, and subsequently re-centered behind the iris plane with the haptics lifted against the iris at 3-o'clock and 9-o'clock position. Simultaneously, an enclavation needle was introduced through the side-port incision, and the midperipheral iris was enclavated by applying gentle pressure through the haptic arms; the maneuver was repeated on the other side. Finally, the viscoelastic device was irrigated from the anterior chamber. Postoperative antibiotic and steroid eyedrops were prescribed, and routine patient follow-up was conducted.

For reenclavation procedures, a 2.2-mm superior corneal incision and one side-port incision were made. After intracameral injection of the viscoelastic device, a lens fixation forceps was inserted to hold the dislocated IOL. Fresh iris tissue was enclavated using an enclavation needle with the same method of the first enclavation surgery (See video below).

Results

During the study period, 225 eyes of 225 patients were implanted with retropupillary iris-claw IOL, of which 22 eyes of 22 patients (9.8%) required reenclavation: 11 of 87 eyes (13%) at Seoul National University Bundang Hospital, and 11 of 138 eyes (8%) at Yonsei University Gangnam Severance Hospital. The mean age of all the patients was 62.5 years ± 13.5 years (range: 14 years to 90 years; proportion of female patients: 19.6%), and no significant difference in age (60.3 years ± 8.9 years vs. 62.8 years ± 13.9 years, respectively; P = .411) and sex (female 9.1% vs. 20.7%, respectively; P = .193) was observed between patients with and without reenclavation.

In the 22 eyes with dislocated iris-claw IOL, the mean time to dislocation was 89 days ± 77 days (range: 5 days to 277 days) from the first IOL implantation. Iris atrophy at the time of dislocation was observed in 13 eyes (59%). For the second surgery, 17 patients (77%) stated that they had no experience of ocular trauma since the retropupillary iris-claw IOL was implanted and five patients (23%) had a history of blurred vision immediately after washing their faces. Ten right eyes (45%) and 12 left eyes (55%) were re-operated. Site of disenclavation was the patient's nasal side in 14 cases (64%), temporal side in eight cases (36%), and there was no case of double haptic disenclavation. Considering the laterality of the eye and dislocated side, 12 cases (55%) were manipulated with the surgeon's left hand and 10 cases (45%) were manipulated with the right hand (Table 1). In all eyes with reenclavation surgery, no intra-operative complications were observed, and central location of the IOL was observed postoperatively (Figure 1). Elevated intraocular pressure (IOP) was observed in two cases after reenclavation, which was resolved with IOP-lowering medication, and re-disenclavation at the same side of haptic was observed in one case 49 days after successful reenclavation, for which, repeat enclavation was performed; no other postoperative complications were observed. The mean follow-up after reenclavation was 10.5 months ± 11.7 months (range: 12 days to 42 months).

Patient Demographics and Characteristics of Retropupillary Iris-Claw IOL Dislocation

Table 1:

Patient Demographics and Characteristics of Retropupillary Iris-Claw IOL Dislocation

Case 6. (A) The right eye of 49-year-old man shows intraocular lens (IOL) with dislocation of the capsular bag. (B) Surgical photograph shows an anterior segment after retropupillary implantation of the iris-claw IOL (arrows). (C) Ninety-six days after first surgery, spontaneous IOL dislocation into the vitreous body (arrowheads) with disenclavated nasal haptic is observed (arrow). (D) After reenclavation, the iris tissue shows enclavation into the haptics at 3-o'clock and 9-o'clock position (arrows).

Figure 1.

Case 6. (A) The right eye of 49-year-old man shows intraocular lens (IOL) with dislocation of the capsular bag. (B) Surgical photograph shows an anterior segment after retropupillary implantation of the iris-claw IOL (arrows). (C) Ninety-six days after first surgery, spontaneous IOL dislocation into the vitreous body (arrowheads) with disenclavated nasal haptic is observed (arrow). (D) After reenclavation, the iris tissue shows enclavation into the haptics at 3-o'clock and 9-o'clock position (arrows).

In the 22 eyes, the mean BCVA before retropupillary iris-claw IOL implantation was 0.66 ± 0.77 logarithm of the minimum angle of resolution (logMAR) and that after retropupillary iris-claw IOL implantation was 0.12 ± 0.24 logMAR, which was considered as significant improvement (P < .001). After IOL dislocation, uncorrected visual acuity was 0.97 ± 0.76 logMAR. After reenclavation surgery, improvement of BCVA value of 0.07 ± 0.17 logMAR was observed, without statistically significant difference compared to that at post-initial retropupillary iris-claw IOL implantation (P = .315). In 19 cases, no statistically significant differences of the mean spherical equivalent between post reenclavation and post-initial surgery were detected (−1.19 ± 1.68 diopters [D] vs. −1.05 ± 1.71 D, respectively; P = .66). In 11 patients, no change of the endothelial cell count of 2,293 ± 550 cells/mm2 after the first enclavation surgery compared to 2,119 ± 599 cells/mm2 following reenclavation was observed (P = .182) (Table 2).

Clinical Outcomes After Retropupillary Iris-Claw IOL Implantation and Reenclavation

Table 2:

Clinical Outcomes After Retropupillary Iris-Claw IOL Implantation and Reenclavation

Discussion

In this study, 22 of 225 eyes (9.8%) showed dislocation of retropupillary fixated iris-claw IOL at an average 3 months' postoperative period at two centers, and the reenclavation technique showed successful performance to achieve re-fixation without serious complications in all these cases.

Implanting a retropupillary iris-fixated IOL in eyes with aphakia or loss of the lens-supporting apparatus was attractive to surgeons and patients because the surgical technique can be technically easier, time saving, and shows similar visual outcomes and safety compared to scleral fixation technique.6,13 Moreover, this approach has no suture-related complications, which are problematic in scleral fixation, and the potential for parallel orientation of the IOL with the iris plane may result in more predictable visual outcomes. However, reports have indicated various intraoperative or postoperative complications including astigmatism secondary to the large wound size caused by single-piece polymethyl methacrylate (PMMA) material,15 pigment dispersion,9,14 pupil ovalization,11,14 secondary glaucoma,12 ocular hypotony,11,12 cystoid macular edema,11,13 and dislocation of the IOL.11,13,14

Among those, dislocation of the IOL is one of the frequent and important complications that requires immediate intervention. Previous studies have reported the rate of dislocation after retropupillary iris-claw IOL-implantation of 0% to 10% at mean follow-up of 5 months to 5.3 years:6,10–12 Forlini et al., three eyes (0.9%) among 320 eyes; Gonnermann et al., 12 eyes (8.8%) among 137 eyes.10,11 In our case series, we obtained a rate of dislocation of 9.8% among 225 eyes, which was within the range of the results of previous studies. Studies focused on secondary IOL implantation with scleral fixation have reported dislocation rate in the range of 2.2% to 27.9% at mean follow-up of 17 months to 6 years.1–3,19 Direct comparison of the dislocation rate between the two techniques is impossible mainly due to differences in follow-up periods among the studies. Nevertheless, there was a trend of higher dislocation rate at the short term after scleral fixation compared to that for retropupillary enclavation technique.1–3,6,11,13,19 Longer follow-up studies of more than 5 years' duration on retropupillary iris-claw IOL are needed to draw a clear conclusion.

Inadequate and asymmetric iris-tissue grasping is a potential mechanism of detachment of the iris-claw haptics,20,21 and we considered that the surgeon's lack of experience may have led to insufficient iris grasping intraprocedurally. Stulting et al. reported that approximately half of the adverse events and preventative repositionings occurred in first 10 cases performed by each investigator using phakic iris-claw IOL.22 Retropupillary implantation of iris-claw IOL is a more challenging surgical technique, which may contribute to the risk. To reduce the risk factor of skill level, surgeons should use sufficient amount of the viscoelastic device during intraocular manipulation to maintain adequate space, and lock the infusion line to control the iris movement in cases where the infusion cannula for vitrectomy is placed. In addition they should consider using a 27-gauge blunt cannula connected to the viscoelastic device to enclavate the iris tissue instead of a sharp enclavation needle recommended by the manufacturer (Ophtec BV), since a thicker needle enables enclavation of more amount of iris tissue.23

The collective findings of the current study and previous studies revealed that most of the dislocations occurred only at a single haptic.17,18 Although the physics responsible for this phenomenon is only speculative at this point, asymmetric traction force might be applied to bilateral enclavation sites and may have led to the drop of the weakly fixed side. If the two fixation points are not directly opposite each other, there may be an asymmetric traction force.

Misaligned haptics owing to intraoperative manipulation or faulty products also can lead to inadequate iris grasping. During reenclavation surgery, we observed misaligned haptic arms in some cases (Figure 2A). Previous studies using light microscopy and scanning electron microscopy reported morphologic alterations of distorted fixation arms and cracks in the haptic material on affected haptics of spontaneous or traumatically subluxated iris-fixated IOL.16,24 Similarly, in our study, we identified a new IOL with misaligned haptic arms even before implantation was performed (Figure 2B). Manufacturing or storage problems are likely to cause production defects of the original IOL, and surgeons should check the haptic cleft under a surgical microscope before implantation of the IOL.

(A) During reenclavation surgery, misalignment of the haptic arms (arrow) is observed within the anterior chamber. (B) A new iris-claw intraocular lens with misaligned haptic arms (arrow) just retrieved from the lens case.

Figure 2.

(A) During reenclavation surgery, misalignment of the haptic arms (arrow) is observed within the anterior chamber. (B) A new iris-claw intraocular lens with misaligned haptic arms (arrow) just retrieved from the lens case.

Atrophy of the enclavated iris tissue can also lead to spontaneous disenclavation of haptics. Previous case series reported that atrophy or depigmentation of the iris was present in all the eyes with spontaneous phakic iris-claw IOL subluxation,7,17,18 which is in contrast to the findings of the current study of atrophy of the iris in 13 eyes (59%) at the time of disenclavation.

Trauma is an established risk factor of dislocation of IOL,10,16,17,25 our study included five cases (23%) with history of face washing before the time of dislocation, which suggests that rubbing or pressure to the eye is a potential risk factor for dislocation of iris-claw IOL in the absence of blunt ocular trauma.

Two studies reported outcomes of reenclavation of subluxated iris-fixated phakic IOL in nine and 25 eyes; the authors confirmed favorable outcomes in terms of visual acuity, endothelial cell density, and refractive error, with no significant adverse effect after reenclavation.17,18 In agreement with those studies, we achieved retropupillary haptic repositioning with favorable outcomes through reenclavation in all cases. In contrast, studies on material analysis of dislocated IOL recommended IOL replacement instead of reenclavation based on findings of considerable damage of the haptics and incapability to achieve capture of adequate amount of the iris tissue.16,24 We also found misalignment of haptics under microscope in the operation room; nevertheless, we were able to easily realign the haptics by passing the needle tip through the haptic arms within the anterior chamber. This simple surgical procedure not only ensures the stability of the iris-claw IOL, but also prevents additional ocular damage that may occur when performing other secondary IOL implantation. We did not examine the IOL with outside light microscopy or scanning electron microscopy, but reenclavation can be performed if distortion of the haptic is reversible.

Our study obtained stable refractive outcome and endothelial cell count after reenclavation, which corroborates with other studies showing lower likelihood of endothelial cell-loss after retropupillary fixation of iris-claw IOL.14,20,26,27 This favorable outcome may extend to reenclavation at the posterior iris, and long-term observation is needed to confirm the results.

Our study has some limitations. First, follow-up was conducted for an average 10.5 months after reenclavation surgery, and long-term follow-up is required to evaluate the stability of re-anchoring of the IOL. Ongoing advancement of surgical techniques will allow better surgical outcomes. Second, evaluation of complete follow-up data was not done due to the retrospective design of the study. Especially, the endothelial cell count could not be evaluated in all patients. In half of the cases that underwent reenclavation, endothelial cell count was maintained stable during the follow-up period. Third, procedures were conducted by four surgeons, but surgeon factors were not considered because all the surgeons are skilled retinal specialists and performed the same procedures.

In conclusion, spontaneous dislocation of retropupillary iris-fixated IOL was not a rare complication. Surgeons should consider the possibility of this complication during surgery, and in the event of such a complication, reenclavation should be considered as a surgical treatment option without major challenges or complications. Additionally, patients should be informed that postoperative IOL dislocation is possible at both early and late stages after surgery, and avoid inflicting ocular trauma. Further studies are needed to confirm long-term safety and efficacy of reenclavation.

References

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Patient Demographics and Characteristics of Retropupillary Iris-Claw IOL Dislocation

Case Eye Time to Dislocation* (Days) Event at Dislocation Disenclavated Side Iris Atrophy SE Change** (D) Follow-Up Period*** (Months)
1 L 29 Unknown Temporal No 0.13 8
2 L 37 Unknown Nasal Yes −0.38 8
3 L 15 After washing face Nasal Yes 0.63 4
4 R 83 Unknown Nasal Yes −1.50 8
5 L 5 Unknown Nasal No 1
6 R 96 Unknown Nasal No −1.75 2
7 R 10 Unknown Nasal No 0.63 5
8 R 37 Unknown Temporal Yes 3
9 R 66 Unknown Nasal Yes −0.25 1
10 L 277 Unknown Temporal Yes −1.38 3
11 L 81 After face washing Temporal Yes 0.38 2
12 R 218 Unknown Temporal Yes 0.63 4
13 R 178 After face washing Nasal Yes 0.75 15
14 L 111 Unknown Temporal No −0.75 18
15 L 231 Unknown Temporal Yes 12 days
16 L 146 Unknown Nasal Yes −0.25 6
17 R 6 Unknown Nasal No 0.75 3
18 R 55 Unknown Nasal No 0 15
19 L 106 After face washing Nasal No −0.25 36
20 R 82 After face washing Temporal Yes 0 42
21 L 59 Unknown Nasal Yes 0.13 18
22 L 31 Unknown Nasal No 0 28

Clinical Outcomes After Retropupillary Iris-Claw IOL Implantation and Reenclavation

After First Implantation After Reenclavation P Value
Best-corrected visual acuity, logMAR (n = 22) 0.12 ± 0.24 0.07 ± 0.17 .315
Refractive error, D (n = 19) −1.05 ± 1.71 −1.19 ± 1.68 .660
Endothelial cell count, cells/mm2 (n = 11) 2,293 ± 550 2,119 ± 599 .182
Authors

From the Department of Ophthalmology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea (MSK, SJP, KJ, SJW); the Department of Ophthalmology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea (HGK, MK).

Supported by the National Research Foundation Bio & Medical Technology Development Program (Grant No. 2018M3A9B5021319) funded by the Korean government (MSIT). The funding organization had no role in the design or conduct of this study.

The authors report no relevant financial disclosures.

Address correspondence to Min Kim, MD, Department of Ophthalmology, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul, 06273, Korea; email: minkim76@gmail.com; and Se Joon Woo, MD, PhD, Department of Ophthalmology, Seoul National University Bundang Hospital, 173-82 Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13620, Korea; email: sejoon1@snu.ac.kr.

Received: December 23, 2019
Accepted: May 27, 2020

10.3928/23258160-20200702-03

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