|Ahead of print publication
Assessment of safety of retropupillary iris-claw intraocular lens as a viable option in surgical aphakia
Minal Doulatramani, Renu Magdum, Rupali Maheshgauri, Radhika Paranjpe
Department of Ophthalmology, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Pune, Maharashtra, India
|Date of Submission||27-Sep-2019|
|Date of Decision||25-Apr-2020|
|Date of Acceptance||12-Jun-2020|
Department of Ophthalmology, Dr. D. Y. Patil Medical College, Hospital and Research Centre, Pimpri, Pune - 411 018, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Aphakia is the most dreaded and inadvertent complication of cataract surgery. Visual rehabilitation with wide variety of surgical options is a challenge for the ophthalmologist. Our study evaluates the safety and efficacy of the retropupillary implantation of the iris-fixated intraocular lens (IOL) in a 2-month follow-up period. Aims: This study aims to assess the visual outcome, identify complications, and assess the long-term stability of eyes undergoing retropupillary iris-claw lens implantation for aphakia. Settings and Design: This was a prospective interventional study (single-group, before–after study). Materials and Methods: Sixty eyes with surgical aphakia fulfilling the inclusion criteria were considered. Preoperatively, evaluation of visual acuity, slit-lamp examination, fundus examination, intraocular pressure, corneal endothelial cell count, macular thickness, and edema was done. Anterior vitrectomy was done, and retropupillary iris-claw lens was implanted. Postoperative best-corrected visual acuity (BCVA), IOP, corneal endothelial cell density, macular edema, and IOL stability were evaluated. Statistical Analysis: The computer software statistical package for the social sciences, version 20.0 (SPSS) was used, and a 0.05 level of significance was considered. Results: The major cause of aphakia was posterior capsular rupture (55%). Postoperative BCVA on day 60 was 6/6–6/18 in 83.33% of cases. Three patients had disenclavation of the haptic which required retucking of IOL. No patient had corneal decompensation, cystoid macular edema, or IOP rise. Conclusion: Our results demonstrate that retropupillary technique of iris-claw implantation is a safe and effective method for visual rehabilitation in aphakic patients. This surgical procedure has an advantage of posterior chamber implantation with a low intraoperative and postoperative complication profile.
Keywords: Aphakia, disenclavation of haptic, iris-claw lens, posterior capsular rupture, retropupillary fixation
|How to cite this URL:|
Doulatramani M, Magdum R, Maheshgauri R, Paranjpe R. Assessment of safety of retropupillary iris-claw intraocular lens as a viable option in surgical aphakia. Med J DY Patil Vidyapeeth [Epub ahead of print] [cited 2021 Feb 28]. Available from: https://www.mjdrdypv.org/preprintarticle.asp?id=309180
| Introduction|| |
The implantation of an intraocular lens (IOL) into the capsular bag or the sulcus remains the best result following cataract surgery. However, leaving a patient aphakic is the most dreaded and inadvertent complication of cataract surgery., Aphakia can be corrected with aphakic spectacles, contact lenses, and implantation of IOLs such as transsclerally sutured posterior chamber (PC) IOL, angle-supported anterior chamber (AC) IOL, or an iris-fixated IOL.,, Angle-supported AC IOLs are rarely used because of the high incidence of secondary glaucoma, bullous keratopathy, pupil distortion, endothelial cell loss, and IOL instability. Transsclerally sutured PC IOLs preserve the anatomy of AC but have a high risk of intra- and postoperative complications with long surgical time and a steep learning curve.,, Iris-fixated lens was introduced in 1979 in India by Daljit Singh for aphakia. Studies report safe implantation of these IOLs even in the pediatric population. The implantation of an iris-claw lens behind the iris plane combines the advantages of a PC IOL and a short surgical time as well as an easy technique. It has a low intra- and postoperative risk profile.,, This prospective interventional study was done to evaluate the safety and efficacy of the retropupillary implantation of the iris-fixated IOL in a 2-month follow-up period by assessing visual outcome, incidence of complications, and its long-term stability.
| Materials and Methods|| |
A prospective interventional study (single-group, before–after study) was conducted in 60 eyes (age group: 10–85 years) with surgical aphakia in a tertiary care hospital in Western Maharashtra from September 2016 to January 2019 after the Institutional Ethics Committee clearance (Letter number: DPU/R and R [M]/979(073)/2016 dated December 29, 2016). Aphakic patients due to dropped fragments or the entire nucleus of the crystalline lens, posterior capsular rupture during cataract extraction, traumatic cataract [Figure 3]a, weak bag dialysis, hypermature cataract [Figure 4]a, subluxated cataract (Marfan syndrome) [Figure 5]a, subluxation, or total dislocation of the IOL that require both anterior and posterior vitrectomy and endothelial cell count (ECC) ≥1500 cells/mm2, and retinal pathology, for example, cystoid macular edema (CME) were included. Patients with torn iris, iridodonesis, rubeosis iridis, total aniridia, and glaucoma were excluded from the study. Informed and written consent was obtained from all the patients in their preferred language. Retropupillary approach for iris-claw intraocular lens (RPICIOL) implantations were primary procedures during intraoperative complications and secondary procedures following postoperative complications. Preoperative assessment included retinoscopy, best-corrected visual acuity (BCVA), slit-lamp examination, IOP with Goldmann applanation tonometry, dilated fundus examination with indirect ophthalmoscopy, corneal ECC with Topcon SP-3000P specular microscope, and macular evaluation by Cirrus HD-OCT 500, Carl Zeiss Meditec. Axial length and IOL power were calculated by Tomey Biometer AL-100. SRK II formula was used to calculate the IOL power in aphakic mode, A-constant of 117.2 for retropupillary implantation. Primary implantation of RPICIOL was undercorrected by +1 D in surgeries with intraoperative complications.
|Figure 3: (a) Preoperative image showing traumatic rosette cataract. (b) Postoperative image showing stable iris-claw intraocular lens with peripheral iridectomy and pupil ovalization due to tucking the intraocular lens near the pupillary margin on the iris|
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|Figure 4: (a) Preoperative image showing hypermature cataract with thin anterior capsule and anterior capsular calcification. (b) Postoperative image showing stable iris-claw lens and round pupil with a peripheral iridectomy at 11 o'clock|
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|Figure 5: (a) Preoperative image left eye showing subluxated lens in Marfan syndrome. (b) Postoperative image left eye, haptic tuck seen|
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All surgeries were performed under peribulbar anesthesia. In case of IOL subluxation, the operation was combined with automated anterior vitrectomy and previous IOL explantation. Cataractous lens along with the bag was removed in patients with traumatic or subluxated cataract. Partial-thickness scleral incision and 5.5-mm length corneoscleral were made, followed by two corneal paracenteses at 3 and 9 o'clock. Intracameral pilocarpine 0.5% was injected. AC was entered followed by injecting viscoelastic (2% hydroxypropyl methylcellulose). Iris-claw IOL to be implanted was a monofocal one-piece biconvex polymethyl methacrylate IOL with an 8-mm length, a 1.04-mm maximum height, and a 5.50-mm optical zone [Figure 2]a, [Figure 2]b. The haptics attach to the iris with clips on both sides of the optic part of the lens. Automated anterior vitrectomy was done by Appa Turbovit machine. In posterior dislocated cataract or IOL, pars plana vitrectomy was also performed. Iris-claw IOL was inserted in the AC, holding it with the iris-claw holding forceps [Figure 1] rotated in such that the haptics were orientated at 3 and 9 o'clock position. The IOL was slipped through the pupil, posterior to the iris, lifted against the iris plane in a way that the haptics become apparent through the iris stroma and enclavation of the mid-peripheral iris between the claw haptics was done with IOL dialer by applying gentle pressure (each haptic singly) through paracentesis. Only a small amount of iris tissue was enclavated at the claw haptics to avoid significant corectopia or pupil ovalization. Peripheral iridectomy (PI) was done at 11 or 12 o'clock position using Vanna's scissors at a surgeon's discretion. Viscoelastic was washed, side port hydration was done, and tunnel was sutured with 10-0 nylon after injecting air bubble. A 0.5-ml subconjunctival injection of gentamicin 20 mg and dexamethasone 2 mg was given. Postoperatively, BCVA, IOP, corneal endothelial cell density, and macular evaluation were done. Shape of pupil, position of tucking, and lens reflex were assessed on postoperative days (PODs) 1, 7, 15, and 60 in all patients. Topical moxifloxacin hydrochloride 0.5% and prednisolone acetate 1% were tapered over 1 month.
| Observations and Results|| |
In total, 60 eyes, ranging from 10 to 85 years, were analyzed with a mean age of 57.63 years. 63.33% of patients belonged to 51–70 years' age group. The causes of aphakia are enumerated in [Table 1]. Forty-two patients (70%) were implanted retropupillary iris-claw lens as a primary procedure, whereas 18 patients (30%) had secondary implantations. Patients were divided into four categories according to visual acuity. 46.67% of cases belonged to preoperative UCVA <1/60. Pre- and postoperative BCVA was compared, and a statistically significant improvement was observed [Table 2]. The BCVA on POD 1 dropped due to corneal edema and AC reaction but increased on day 7, day 15, and day 60 (P < 0.0001) [Table 3]. A reduction in ECC (6.24%) was statistically significant (P < 0.001). The pre- and postoperative IOP was similar, mean = 14.37 mmHg [Table 4]. Surgical PI was performed in 48 eyes (80%). The mean postoperative IOP in patients with surgical PI was 14.38 mmHg (standard deviation [SD] = 1.498) and those without surgical PI was 14.33 mmHg (SD = 1.211). This was not statistically significant (P = 0.95). Four patients who had CME postoperatively had edema preoperatively as well. This was calculated by McNemar's Chi-square = 0, P = 1. Ovalization of pupil was a major complication after retropupillary iris-claw implantation in 35 patients (58.33%), whereas 3 patients (5%) had unstable IOL (disenclavation of the haptic) which required retucking of IOL.
|Table 2: Comparison of preoperative best-corrected visual acuity and postoperative best-corrected visual acuity on day 1 and day 60 in study group|
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|Table 3: Comparison of postoperative best-corrected visual acuity on postoperative day 1, day 7, day 15, and day 60 in study group|
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|Table 4: Comparison of pre- and postoperative endothelial cell count and intraocular pressure in study group|
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| Discussion|| |
The best outcome of a cataract surgery is IOL implantation in the bag. With various options available for correcting surgical aphakia, selecting the best option still remains a challenge for the ophthalmologist. The method which offers the lowest complication rate and the best possible visual outcome must be chosen. There are very few studies on retropupillary implantation in Indian patients; hence, this study has been conducted with the aim of assessing the safety of retropupillary iris-claw lens in aphakia rehabilitation with good vision and least complications.,,,,,,
In our study of 60 eyes, 83.33% achieved BCVA of 6/6–6/18 on POD 60 [Table 3]. None of our patients had chronic AC inflammation, similar to a study by Jare et al. and Forlini et al., This increase in vision was highly encouraging (P < 0.0001) In a study conducted by Jayamadhury et al. in 2016, preoperative BCVA was achieved in 77.04% by 1 month and 98.30% by 3 months. Lett and Chaudhuri, in 2011, showed that 66.6% of patients achieved a final vision better than that recorded preoperatively. 64.1% of patients achieved final vision of 6/12 or better. Rao and Sasidharan found that 80% of patients had good vision (20/20–20/40) at 6 months.
Jayamadhury et al. reported a 11.76% decrease in mean ECC at 1-year follow-up (P = 0.006)., Anbari and Lake also reported mean endothelial cell loss (P = 0.0005). In a study conducted by Jare et al., the mean difference in ECC before and 1 month postsurgery was 104.21 cells/mm2 (4.92%) comparable to any other IOL surgery (P = 0.91). Rao and Sasidharan in their secondary retropupillary iris-claw implantation study (2013) reported endothelial cell loss of 8.96% at 6 months. Forlini et al. did not report any statistically significant decrease in ECC (P = 0.96). Further studies must be done to evaluate the endothelial cell loss on long-term basis after retropupillary iris-claw implantation.
Jayamadhury et al. reported mean preoperative IOP 14.37 ± 5.44 mmHg and mean postoperative IOP 14.32 ± 5.18 mmHg, which was not statistically significant (P = 0.45). No case of chronic secondary glaucoma at 1-year follow-up was reported. Jare et al. had raised IOP postoperative in three eyes in the 1st postoperative week which was managed by neodymium: yttrium-aluminum-garnet laser PI. Surgical PI was a routine in every case of retropupillary iris-claw IOL [Figure 4]b. A similar increase in postoperative IOP was observed in 1 out of 31 patients by Schallenberg et al. A study by Gonnermann et al. reported elevated IOP in 4.3% of cases.
Forlini et al. did not perform surgical PI in any case, and they saw elevated IOP in seven cases, which was managed medically., No case of pupillary block occurred since there is adequate space between the lens optic and back of the iris. There is posterior vaulting of iris-claw lens when implanted in reverse position retropupillary.
Jare et al. observed that the central macular thickness preoperatively and at 6-month follow-up had no statistical difference (P = 0.078). Hence, no CME was seen in their study, like studies by Schallenberg et al. and Lett and Chaudhuri., Jayamadhury et al. reported 7 cases (11.47%) of CME, with a peak incidence at 6 months. Forlini et al. reported three cases of CME, which developed 2 months after vitrectomy and retropupillary lens implantation for posteriorly dislocated IOL. Gonnermann et al. reported CME in 8.7% (12 out of 137 patients).
We observed ovalization of the pupil due to tucking the lens haptic near the pupillary margin [Figure 3]b. Hence, the iris-claw lens requires tucking in the mid-peripheral iris to maintain the pupil shape. Postoperatively, diagnostic pupil dilatation remained unaffected. Other studies reported ovalization of pupil in 9.83%, 5%, and 32.25% of cases.
In 3 patients (5%) in our study, one haptic of the iris-claw lens was disenclavated, which required retucking of IOL, which occurred due to failed enclavation or inadequate iris tissue grasping by the lens haptic [Figure 6]a. Forlini et al. noted three cases of disenclavation at a mean follow-up of 12 months and one case of spontaneous posterior disenclavation in the vitreous cavity. Gonnermann et al. reported disenclavation in 8.7% (12 out of 137 cases) at an average of 3.3 months postsurgery. Jare et al., Jayamadhury et al., and Schallenberg et al. had no decentration or dislocation in their case series.,, Proper surgical technique along with adequate iris tissue tuck will prevent postoperative disenclavation [Figure 6]b.
|Figure 6: (a) Preoperative image showing unstable iris-claw intraocular lens with only one haptic tuck at 4 o'clock. (b) Postoperative image showing stable iris-claw intraocular lens and haptic tucks at 4 and 9 o'clock|
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No complication such as uveitis, posterior synechiae, or iridodonesis after retropupillary implantation was observed in our study. Forlini et al. reported 5 out of 320 patients with severe iridodonesis postoperatively. No case had pigment dispersion, iris atrophy, toxic anterior segment syndrome, hyphema, or hypotony in our study.,, Iris atrophy was reported by Schallenberg et al. and Jayamadhury et al.,
We did not report any sight-threatening complications such as retinal detachment or choroidal detachment.,,
Retropupillary iris-claw IOL needs initial learning but can be performed by an anterior segment surgeon with ease, unlike scleral-fixated IOL which is challenging and needs special training.
| Conclusion|| |
Initially, the iris-claw lens placed anteriorly had contact with the corneal endothelium, which created a psychological barrier to the use of these lenses in general. Long-term results demonstrate that retropupillary technique of iris-claw implantation is a safe and effective method for predictable visual rehabilitation in aphakic patients. Tucking the haptics in mid-peripheral iris with adequate iris tissue will increase the long-term stability of iris-claw lens and decrease the chances of disenclavation [Figure 5]b. This surgical procedure has an advantage of PC implantation with a low intraoperative and postoperative complication profile.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2], [Table 3], [Table 4]