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ORIGINAL ARTICLE
Ahead of print publication  

Visual outcome of intraocular Iris–Claw lens implantation in Indonesian children with ectopia lentis


 Department of Pediatric Ophthalmology, Cipto Mangunkusumo National Central General Hospital, Jakarta, Indonesia

Date of Submission29-Aug-2021
Date of Acceptance13-Dec-2021
Date of Web Publication28-Feb-2022

Correspondence Address:
Dian E Yulia,
Department of Ophthalmology, Cipto Mangunkusumo National Central General Hospital, Jl. Kimia No. 8, Jakarta
Indonesia
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/tjo.tjo_58_21

  Abstract 


PURPOSE: The purpose of the study was to describe the visual outcomes of anterior chamber iris–claw intraocular lens (IOL) implantation in pediatric ectopia lentis.
MATERIALS AND METHODS: A retrospective review was conducted on the medical records of children with ectopia lentis who underwent primary anterior iris–claw IOL implantation at a national referral hospital in Indonesia in the years 2013–2020. Primary outcomes include visual acuity (VA) and postoperative complications. Postoperative data were collected at 1-year follow-up.
RESULTS: A total of 26 eyes of 17 patients were included, the average age at surgery was 9 (5–14) years. Uncorrected VA significantly improved (P = 0.000) from an average of 1.6 ± 0.35 logMAR preoperatively to 0.7 ± 0.33 logMAR postoperatively, best-corrected VA also significantly improved, and 77% of eyes that achieved a postoperative best-corrected VA of 0.3 logMAR. Postoperative complications were reported in three eyes, including elevated intraocular pressure, IOL de-enclavation, severe inflammation, and endophthalmitis; all cases were promptly treated and had good visual outcomes. The mean onset of complications was roughly 3 months (77 ± 129 days) after surgery.
CONCLUSION: Anterior iris–claw implantation in children with ectopia lentis appear to be effective in achieving good visual outcome. With its relatively simple technique, anterior iris–claw implantation can potentially serve as a favorable option for the treatment of pediatric ectopia lentis. Long-term prospective research with larger sample sizes is needed.

Keywords: Children, ectopia lentis, intraocular lens implantation, iris–claw, visual outcome



How to cite this URL:
Yulia DE, Barliana JD, Soeharto DA. Visual outcome of intraocular Iris–Claw lens implantation in Indonesian children with ectopia lentis. Taiwan J Ophthalmol [Epub ahead of print] [cited 2022 Sep 28]. Available from: https://www.e-tjo.org/preprintarticle.asp?id=338539




  Introduction Top


Ectopia lentis is a condition that involves displacement of the crystalline lens that occurs as a result of weakened or damaged zonules. Considerably rare in the population, ectopia lentis is often found in patients with underlying systemic diseases such as Marfan syndrome.[1] Management of pediatric ectopia lentis can be approached with a conservative visual correction or with surgical management. Without appropriate visual rehabilitation, significant progressive refractive error and amblyopia may occur. Moreover, left untreated can further displace into the anterior or posterior chamber, in turn potentially causing corneal endothelium damage, closed-angle pupillary block glaucoma, and retinal detachment.[2],[3],[4] Surgical intervention is therefore indicated in cases of poor best-corrected visual acuity (BCVA) and progressive severity of subluxation.[5],[6] In general, surgical management involves removal of the crystalline lens, leaving the eye aphakic, followed by correction with either glasses, contact lens, or implantation of intraocular lens (IOL).[4] Indications for IOL implantation include patient intolerance toward contact lenses or myopic glasses. Contact lenses carry the risk of erosion or infection of the corneal epithelium, and is highly dependent on patient or caregiver compliance, and aphakic glasses are often difficult for children to tolerate due to potential visual disturbances such as prismatic distortion and constriction of visual fields, as well as the heaviness of wearing the glasses themselves.[3],[4],[5]

To date, the literature regarding absolute indications for surgery and insertion of an IOLs in the pediatric population is very limited.[4],[7] There are several techniques for IOL implantation that can be considered in cases with weak zonules, these options include scleral-fixation technique as well as iris enclavation technique using iris–claw IOL. Iris–claw IOLs can be deemed superior as they do not require manipulation of the posterior segment, and involve a relatively simple and fast procedure, thus potentially reducing the risk of posterior segment complications such as vitreous hemorrhage and endophthalmitis. This is especially beneficial for ectopia lentis patients with Marfan syndrome, as these patients have a much higher risk of retinal detachment.[7],[8],[9],[10]

Safety and efficacy of iris–claw IOL implants in adults are thoroughly studied;[11] however, such studies in the pediatric population are still very much limited.[8] This study aimed to elucidate the visual outcomes of iris–claw IOL implants in children with ectopia lentis, as well as illustrate the potential complications that are to be expected in a 1-year follow-up.


  Materials and Methods Top


A retrospective review was performed on medical records of pediatric patients with ectopia lentis who underwent anterior iris–claw IOL implants at the Department of Ophthalmology, Cipto Mangunkusumo Kirana National Referral Hospital, Jakarta, Indonesia, in the years 2013–2020. This study was granted ethical approval (Protocol Number: 21-05-0517; Approval Date: June 21, 2021) by the Health Research Ethics Committee of University of Indonesia–Cipto Mangunkusumo Hospital (HREC-FMUI/CMH) and in accordance with the Declaration of Helsinki. Patients who had ectopia lentis secondary to trauma, and whose medical records were incomplete or could not be accessed were excluded. Extracted preoperative data include age, gender, etiology, laterality, uncorrected visual acuity (UCVA), and BCVA. Postoperative data were collected at 1-year follow-up, and included postoperative UCVA and BCVA, refractive error (converted to spherical equivalent), complications, and complication onset from the day of surgery. Measurement of endothelial cell density was attempted; however due to lack of patient cooperation, insufficient data were collected and thus was excluded from our analysis.

Indication for implantation of iris–claw IOL was ectopia lentis patients whose visual acuity (VA) could not be corrected with or could not tolerate contact lens or glasses. Anterior chamber depth was examined was using A-scan. Biometry was performed under general anesthesia in order to determine IOL power for each patient with their respective target refraction according to the rule of seven based on the A-constant of the anterior iris–claw IOL. The target refraction of emmetropia in patients above 7 years of age, whereas patients below 7 years old had a target refraction based on the rule of seven.

The surgery discussed in this study used a one-staged surgery primary IOL implantation procedure, which included lens extraction, anterior vitrectomy, and anterior iris–claw lens implantation. Surgery was performed by two surgeons using the same standardized procedure and performed under general anesthesia. The procedure started with a 2.2 mm incision at the limbus made at the 11 o'clock position, and cohesive viscoelastic was then injected into the anterior chamber. Afterward, we performed a continuous curvilinear capsulorrhexis with microforceps, and another limbal incision was made at the temporal limbus. Irrigation and aspiration of lens material was conducted with a bimanual handpiece, extraction of the crystalline lens was performed, and anterior vitrectomy was performed to extract the capsule, ensuring complete removal of the lens and capsule. If necessary, a vitrectomy was performed to ensure the vitreous was clear from wound site. Afterward, we injected miotic agent to constrict the pupil, cohesive viscoelastic was inserted, and the limbal incision was widened according to the diameter of the optics of the IOL. We then performed a paracentesis facing downward on each side of the main incision site. All cases used a biconvex polymethyl methacrylate aphakia iris–claw IOL. The iris–claw IOL was then inserted into the anterior chamber in a vertical orientation through the corneal incision, then rotated 90° to be positioned over the pupil, and its haptics were enclaved anteriorly onto the iris at three and nine o'clock. After enclavation, ensure that the IOL is centered over the pupil and the amount of enclavated iris tissue is adequate. Peripheral iridectomy was then performed, and viscoelastic was then washed out. At the end of surgery, 0.1 mL intracameral levofloxacin was injected, and the incision was closed with nylon 10-0 sutures. Postoperatively, all patients were prescribed levofloxacin eye drops and prednisolone acetate eye drops, these were initially administered six times a day and tapered off over 1 month.

A descriptive analysis on the characteristics of the subjects was done, quantitative variables were reported as mean (standard deviation) or median (min-max) depending on normality determined by Kolmogorov–Smirnov test. Categorical variables were presented in frequency and percentage. VA was converted to logMAR for analysis. Association between preoperative and postoperative VA was analyzed using paired samples t-test, and measure of association between the two variables was reported as the difference between means (P value) and was defined as significant if P < 0.05. Data were inserted into Microsoft Office Excel version 16.48 and then analyzed using IBM SPSS Statistics for Mac version 26 (IBM Corp., Armonk, N.Y., USA).


  Results Top


We included 26 eyes of 17 patients in this retrospective study, nine cases were bilateral and eight cases were unilateral. Distribution of subject demographics is shown in [Table 1]. Females accounted for slightly more than half (58.8%) of the patient population. The etiology of ectopia lentis was mostly unspecified, with 76.5% of the patients having unconfirmed or unidentified underlying systemic diseases. However, four patients were confirmed to have Marfan syndrome as determined by the pediatrics department at our hospital. The average age of the patients at initial presentation to our hospital was 9.1 ± 3.0 years.
Table 1: Distribution of subject demographics (n=17)

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A total of 26 eyes underwent anterior iris–claw IOL implantation, and the average age at surgery was 9.0 ± 2.8 years (range 5–14 years). VA was compared between the patients' baseline preoperative state and after the operation at the 1-year follow-up, as shown in [Table 2]. All eyes had an improvement in UCVA, and the average postoperative UCVA (0.7 ± 0.3 logMAR) was higher than its baseline preoperatively (1.6 ± 0.3 logMAR), and this improvement in UCVA was statistically significant (P = 0.000).
Table 2: Visual outcomes (n=26)

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There was also an improvement between the mean preoperative BCVA (1.0 ± 0.6 logMAR) and the mean postoperative BCVA (0.3 ± 0.3 logMAR), and this increase in BCVA was also found to be statistically significant (P = 0.000). One eye did not experience an improvement in BCVA, and this patient had preexisting amblyopia. Twenty out of 26 (76.9%) eyes achieved a postoperative BCVA of 6/12 or 0.3 logMAR.

The median refractive target was + 0.13 D (range −5.00D to + 1.42 D), and mean postoperative refractive error was −1.64 ± 1.38 D. Mean difference between average refractive target and average postoperative refractive error was + 1.40 ± 1.37 D, and this difference is statistically significant (P = 0.000).

Within the 1-year follow-up period of this retrospective study, three out of 26 eyes (11.5%) were reported to have postoperative complications. The mean onset of complications was roughly 3 months (77 ± 129.3 days) after surgery [Table 3].
Table 3: Postoperative complications within 1-year follow-up (n=26)

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Elevated intraocular pressure (IOP) was observed in two eyes of the same patient, in which the patient's left eye had a transient elevation of IOP 2 weeks after surgery and was successfully managed with topical timolol 0.5%, and the IOP was normal within 1 week. In the same patient, their right eye was observed to have severe inflammation and secondary glaucoma 2 weeks after surgery, and this eye was treated with oral acetazolamide, topical timolol 0.5%, topical levofloxacin, and topical prednisolone, and inflammation resolved within 3 weeks. The same eye required synechiolysis 11 months after surgery, and also underwent IOL re-enclavation in the same procedure. After the aforementioned management, both eyes of this patient had good VA (6/9 or 0.18 logMAR in both eyes) at last follow-up. Another eye was reported to have endophthalmitis 1 month after surgery, this was confirmed to be as a result of external factors, and this patient was successfully treated with intravitreal vancomycin and ceftazidime, resulting in good VA (6/7.5 or 0.10 logMAR) at last follow-up.


  Discussion Top


This study illustrated a 1-year follow-up of 26 eyes of 17 children with ectopia lentis who underwent primary implantation of iris–claw IOL. Surgery and IOL implantation in these patients were indicated mainly due to poor BCVA or intolerance toward glasses. IOL implantation was decided upon as it offers relatively permanent refractive error correction, whereas good visual outcome in patients who are left aphakic is strongly dependent on compliance.[3] Primary IOL implantation, in which lens extraction and IOL implantation were done in the same procedure, was implemented in all patients in this study. Primary implantation was chosen rather than aphakia or secondary implantation to avoid multiple surgical procedures. Moreover, primary IOL implantation is appropriate as our study population comprised mainly of older children, with the average age at the time of surgery being 9.0 ± 2.8 years. This is in accordance with previous literature, which recommended primary IOL implantation if patients were at least 2 to 3 years of age, while those younger were recommended to be first left aphakic and corrected conservatively.[6],[12] Primary implantation is increasingly commonplace in older children, whereas primary IOL implantation in younger children (below 2 years old) entails factors of immaturity and risk of inflammation, and is thus often avoided.[13] In cases with weak zonules, there are several alternative techniques for IOL implantation, including scleral-fixation and iris–claw IOLs. Iris–claw IOLs can be deemed superior since they do not require posterior segment manipulation and entail a reasonably easy and quick procedure.[7],[8],[9],[10]

Our study demonstrated good visual outcome following iris–claw IOL implantation, with a statistically significant improvement in UCVA and BCVA after implantation. Previous studies have exemplified improved visual outcome after iris–claw lens implants in pediatric ectopia lentis, with statistically significant improvement between preoperative and postoperative VA.[5],[7],[10],[14],[15] All eyes in our study had an improvement in UCVA, and almost all eyes had an improvement in BCVA. One eye had BCVA that did not change between baseline and at last follow-up, and is due to the fact that this patient had preexisting amblyopia. This finding is similar to that of Brandner et al.'s study on retropupil iris–claw that reported the BCVA of two eyes of one patient that did not rise postoperatively, where this patient had preexisting mild amblyopia and nystagmus.[16]

Our study found that 20 out of 26 (76.9%) eyes achieved a good postoperative BCVA of 6/12 (0.3 logMAR) or greater. Similarly, studies by Rezar-Dreindl et al. and Shuaib et al. had comparable rates at 71% and 80% of their respective cohorts implanted with retropupil iris–claw with a BCVA <0.3 logMAR.[6],[17] The latter study also compared the proportion with BCVA <0.3 logMAR in a group of eyes that had scleral fixation IOL (SF-IOL) instead, which was lower at 52.3%.[17] Manning et al. also reported that patients implanted with lensectomy with or without anterior iris–claw IOL with 93.3% of the eyes in their cohort had a postoperative BCVA of 0.18 logMAR (6/9) or better.[5]

Rate of complications within 1 year of follow-up was relatively low in this study's population, with only three out of 26 eyes (11.5%) that were reported to have postoperative complications. Two eyes of one patient experienced elevated IOP, both cases occurring 2 weeks postoperatively, in which one was simply treated with glaucoma medication and IOP returned to normal 1 week after, while the other eye had secondary glaucoma in conjunction with severe inflammation. The rate of glaucoma is comparable with findings from Gawdat et al. and Manning et al. which evaluated eyes with anterior iris–claw, each reporting one case of pupillary block glaucoma and required peripheral iridectomy that occurred at 3 days and 5 months after surgery, respectively.[5],[15]

Similar findings are reported in studies on retropupil iris–claw, with one case that required trabeculectomy,[17] and one that was transient where IOP normalized without specific management.[16] Rastogi et al.'s study on retropupil iris–claw IOL also reported one case of acute elevation of IOP which was controlled within a week with topical timolol 0.5% and oral acetazolamide.[18] Furthermore, one study stated that the incidence of acute angle-closure glaucoma following anterior iris–claw IOL implantation has been reported to be 0%–7%, which is lower than the incidence reported after secondary scleral-fixed posterior chamber IOL implantation (0%–30.7%).[19] With regard to this, we implemented simultaneous peripheral iridectomy at the end of the procedure following IOL implantation in our patients and recommend this approach.

De-enclavation of IOL haptics was found in one eye 11 months after surgery; the patient presented with eye redness and discomfort and examination revealed conjunctival injection and de-enclavated haptic in the temporal region, and they underwent successful re-enclavation. Time after surgery at which IOL de-enclavation has been observed to occur in other studies varies, ranging from 2 to 84 months after surgery,[1],[5],[7],[10],[15] one study also reported de-enclavation 1 day after surgery.[18] Most studies reported de-enclavation secondary to trauma, all cases of which were re-enclavated promptly and had subsequent good outcomes.[7],[10],[15],[16] Gonnermann et al. described a case of retropupil iris–claw IOL dislocation into the anterior chamber secondary to blunt trauma, which required explantation and IOL exchange.[20]

There was one case of severe inflammation and one case of endophthalmitis in two separate eyes. Severe inflammation is rarely reported in other studies, only one study had one eye with sterile anterior uveitis after anterior iris–claw implantation, which was treated with topical corticosteroids, and this case developed cystoid macular edema 3.5 years after.[10] Inflammation is more often a concern in SF-IOL, in which one study found five eyes with transient anterior uveitis <1 month after surgery,[21] and one eye in another study that had uveitis–glaucoma–hyphema syndrome.[22] In an adult study on iris–claw versus SF-IOL, acute postoperative inflammation in terms of anterior chamber cells was seen in about 60% of patients in both groups at the first follow-up, and only one patient in the SF-IOL group had uveitis longer than a month after surgery.[23]

There were no cases of retinal detachment in our study. Other studies on anterior iris–claw on pediatric ectopia lentis with an average follow-up of 3–4 years also reported no cases of retinal detachment.[5],[6] One study, however, reported one case of retinal detachment after severe blunt trauma to the eye.[10] By contrast, Fan et al., who evaluated anterior iris–claw in adults and children with Marfan syndrome, observed 11/64 (17.2%) eyes with retinal detachment, with a range of onset from 1 to 48 months, their analysis revealed that individuals with detached retinas had a more severe grade of lens dislocation and greater axial myopia; hence, even without surgical intervention, a higher risk of retinal detachment was inherent in eyes with Marfan, of which those aforementioned risk factors are commonly present. Moreover, Fan et al.'s study mentioned that they used a pars plana approach in their patients with severely dislocated lenses or detected retinal breaks preoperatively.[12] Theoretically, pars plana allows for complete vitreous evacuation and detection of retinal breaks. However, current literature does not show pars plana as superior over limbal approach.[3] Notably, our study applied a limbal approach to all eyes, which required no posterior involvement and less trauma and traction of the vitreous.

When adopting the iris–claw approach, corneal endothelial cell decompensation is a big concern. Endothelial cell density at birth is estimated to be 6000 cells/m2 and progressively decreases, with reports of endothelial cell density decreasing rapidly up to the age of 10 years, with a 13% decline in between the ages of 5 and 7 years and a further 12% decrease by the age of 10 years.[15],[24] In a 5-year-old child, the average endothelial cell count is approximately 4000 cells/mm2 compared to 2500 cells/mm2 in adults.[25] Manning et al. reported mean cell loss of 477 ± 606 cells/m2, representing a cell loss of 15.4% of over 4 years of follow-up after lensectomy with or without anterior iris–claw. Notably, one eye in their study found an endothelial cell density <2000 cells/mm2.5 Similarly, Gawdat et al. reported a significant reduction at 12 months with a mean endothelial cell density loss of 6.1%.[15] By contrast, Sminia et al. discovered no statistically significant change in endothelial cell density after follow-up of more than 12 years, and revealed that the endothelial cell density was normal and comparable to the control group (eyes without lens surgery).[14] Lifshitz et al. also highlighted that there was no significance in terms of endothelial cell density changes between the eye that underwent anterior iris–claw implant and the eye that did not undergo surgery.[2] Furthermore, while endothelial cell loss is mostly highlighted as a concern of anterior chamber implantation, retropupil placement of iris–claw in Rastogi et al.'s study also showed mean corneal endothelial cell count decrease 6 months postoperatively, although not statistically significant.[18] Cleary et al. argued that despite long-term endothelial cell loss, the intermediate distance between the endothelium and the IOL remained within the safe range.[8] Although some may recommend that retropupillary fixation of the iris–claw IOL can preserve corneal endothelium and offer a more physiological optical position of the lens, it remains debatable whether or not retropupillary implantation is truly superior to anterior chamber implantation. Furthermore, a study by Mora et al. exploring anterior versus retro-pupil iris–claw IOLs also found that no difference was observed in refractive error, and both groups showed similarly marked endothelial cell density loss. Anterior implantation, in our experience, is easier and provides for greater control of centration and orientation of the lens, and such view is also supported in previous studies.[19],[26]

To our knowledge, current literature on iris–claw IOL implantation, specifically in pediatric ectopia lentis, is still very limited. Our sample size of 26 eyes, although small, serves as an appropriate illustration of this study population, considering how rare pediatric ectopia lentis is in the general population. Understanding the concerns for long-term potential complications, limitations of our study include the small number of patients, limited follow-up time of 12 months, and lack of data on endothelial cell density.


  Conclusion Top


In children with ectopia lentis, anterior iris–claw implantation appears to be successful in attaining a satisfactory VA and has relatively low rates of postoperative complication after 1 year. Complications encountered include elevated IOP, glaucoma, and severe inflammation, as well as endophthalmitis, all of which were promptly managed and resulted in good outcomes. Anterior iris–claw, as opposed to other techniques, serves as a uniquely simple procedure that is effective in achieving comparable outcomes. As a result, anterior iris–claw implantation may be considered a viable alternative for treating pediatric ectopia lentis. Long-term prospective studies with bigger sample numbers are required.

Financial support and sponsorship

Nil.

Conflicts of interest

The authors declare that there are no conflicts of interests of this paper.



 
  References Top

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Barbara R, Rufai SR, Tan N, Self JE. Is an iris claw IOL a good option for correcting surgically induced aphakia in children? A review of the literature and illustrative case study. Eye (Lond) 2016;30:1155-9.  Back to cited text no. 7
    
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Stulting RD, John ME, Maloney RK, Assil KK, Arrowsmith PN, Thompson VM, et al. Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food and Drug Administration clinical trial. Ophthalmology 2008;115:464-72.e1.  Back to cited text no. 11
    
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Sminia ML, Odenthal MT, Prick LJ, Cobben JM, Mourits MP, Völker-Dieben HJ. Long-term follow-up after bilateral Artisan aphakia intraocular lens implantation in two children with Marfan syndrome. J AAPOS 2012;16:92-4.  Back to cited text no. 14
    
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Brandner M, Thaler-Saliba S, Plainer S, Vidic B, El-Shabrawi Y, Ardjomand N. Retropupillary fixation of iris-claw intraocular lens for aphakic eyes in children. PLoS One 2015;10:e0126614.  Back to cited text no. 16
    
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Shuaib AM, El Sayed Y, Kamal A, El Sanabary Z, Elhilali H. Transscleral sutureless intraocular lens versus retropupillary iris-claw lens fixation for paediatric aphakia without capsular support: A randomized study. Acta Ophthalmol 2019;97:e850-9.  Back to cited text no. 17
    
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20.
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Byrd JM, Young MP, Liu W, Zhang Y, Tate DB, Crandall AS, et al. Long-term outcomes for pediatric patients having transscleral fixation of the capsular bag with intraocular lens for ectopia lentis. J Cataract Refract Surg 2018;44:603-9.  Back to cited text no. 22
    
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25.
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26.
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