Iris-claw Phakic Intraocular Lens Implantation Research Articles

Anterior Chamber Iris-Fixated Phakic Intraocular Lens Implantation for Treatment of High Anisometropia in Children: Long-term Results.

To evaluate the long-term efficacy of anterior chamber iris-fixated phakic intraocular lens (PIOL) implantation in the treatment of high myopic (> -9.00 diopters [D]) or hyperopic (> +6.00 D) anisometropia in children with intolerance to spectacles or contact lenses. A total of 58 children with anisometropic myopia (range: -9.25 to -18.50 diopters [D]) and 13 children with anisometropic hyperopia (range: +6.00 to +8.50 D) underwent unilateral iris-claw PIOL implantation from 2008 to 2018. The mean age was 6.7 years. The mean follow-up was 38.5 months. Target refraction was emmetropia. The cycloplegic refraction (mean spherical equivalent) improved from -12.47 D (range: -9.25 to -18.50 D) to -0.73 D (range: +0.75 to -1.50 D) in myopic eyes and reduced from +7.15 D (range: +6.00 to +8.50 D) to +0.94 D (range: -0.50 to + 1.75 D) in hyperopic eyes. Eighty-four percent of eyes were corrected to within ±1.00 D of emmetropia. The mean uncorrected distance visual acuity (UDVA) improved from 1.74 ± 0.36 to 0.45 ± 0.28 logarithm of the minimum angle of resolution (logMAR) (P = .0014). The mean corrected distance visual acuity (CDVA) changed from 0.68 ± 0.32 to 0.27 ± 0.15 logMAR (P = .02179). The safety index was 2.18 and the efficacy index was 1.51. The mean preoperative endothelial cell count of 2,874.7 cells/mm2 changed to 2,685.3 cells/mm2 at 2 to 6 years postoperatively. Binocular vision quality was improved in 55 patients. No patient had serious complications or lost any Snellen lines of CDVA. Iris-fixated PIOL implantation is an effective and safe method in the treatment of high anisome-tropic myopia and hyperopia and amblyopia in pediatric patients who are noncompliant with spectacles or contact lenses. [J Pediatr Ophthalmol Strabismus. 2023;60(3):203-209.].

Long-time follow-up results of phakic posterior chamber intraocular lens and iris-claw phakic intraocular lens implantation for high myopia

Background With the development of refractive surgery, phakic intraocular lens implantation (PIOL) for high myopia is proving its outstanding merits in short-term treating outcomes.However, its long-term safety and effectiveness were still in more attention. Objective This study was to evaluate and compare the long-term safety, stability and efficacy of Verisyse PIOL implantation with implantable contact lens (ICL) implantation for high myopia. Methods The clinical data of 18 eyes (9 patients) who received Verisyse iris-claw intraocular lens implantation for high myopia and matched 22 eyes (11 patients) who received ICL implantation for high myopia from 2009 to 2011 were retrospectively analyzed.The patients were followed-up for 2 years after surgery.Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), spherical equivalence (SE), axial length, corneal endothelial cell density (ECD), contrast sensitivity (CS), wave-front aberrations and postoperative complications were recorded during the following-up.The efficacy index, predictable and safety index were compared between the two groups. Results There was no significant difference in UCVA, BCVA and SE between Verisyse group and ICL group (t=0.92, 1.32, 4.32; all at P>0.05). Non-glare CS under the 1.5, 3.0, 6.0, 12.0 and 18.0 c/d spatial frequencies were insignificantly different between the two groups(Z=0.782, 0.956, 0.495, 0.874, 0.293; all at P>0.05), and the similar outcomes were found in glare CS (Z=0.985, 1.254, 0.896, 1.652, 0.492; all at P>0.05) in postoperative 2 years.Root meas square of total high order aberration (RMSh), vertical-trefoil, vertical-coma, horizontal-coma, spherical aberration(SA), were significantly elevated in the Verisyse group compared with the ICL group (Z=4.72, 4.24, 3.12, 3.65, 2.16; all at P 0.05). The mean safety index was 140.56±33.89 in the Verisyse group and 143.34±34.56 in the ICL group, with a significant difference between them (t=0.29, P>0.05). The mean predictable index was -0.25(-0.97, 4.23)in the Verisyse group and 0.98 (-1.44, 1.52) in the ICL group, and the difference was significant(Z=-2.68, P<0.05). Conclusions Both Verisyse PIOL implantation and ICL implantation for high myopia are safe, predictable and effective.The vusial quality and predictability of ICL implantation are much better than Verisyse PIOL implantation.A long-term effect should be observed for the further evaluation. Key words: Lens implantation, intraocular/methods; Myopia/surgery; Postoperative complications; Phakic eye; Retrospective studies; Safety; Treatment outcome, long-term

Paired-eye comparison of corneal endothelial cell counts after unilateral iris-claw phakic intraocular lens implantation

To compare the corneal endothelial cell density (ECD) after unilateral iris-claw phakic intraocular lens (pIOL) implantation. Instituto de Microcirugia Ocular, Barcelona, Spain. Retrospective interventional nonrandomized paired-eye comparison. Patients who had pIOL implantation in 1 eye and corneal refractive surgery (Group 1) or no surgery in the fellow eye (Group 2) between 1998 and 2010 were included. The main outcome measures were central corneal ECD and the percentage of corneal endothelial cell loss. Secondary outcome measures were uncorrected distance visual acuity, corrected distance visual acuity, manifest refraction, and complications. Outcome measures were analyzed 1, 5, and 10 years postoperatively. Both groups comprised 29 patients. Ten years after surgery, the mean endothelial cell loss was 6.41% ± 8.02% (SD) (Group 1, iris-claw pIOLs), 5.59% ± 5.98% (Group 1, corneal refractive surgery), 7.84% ± 6.83% (Group 2, iris-claw pIOLs), and 6.74% ± 3.97% (Group 2, no surgery). No significant endothelial cell loss was observed after pIOL implantation or corneal refractive surgery at any timepoint (P > .05). No significant differences were observed in the percentage of endothelial cell loss between the groups (P > .05). Iris-claw pIOL implantation did not produce significant corneal endothelial cell loss up to 10 years after surgery compared with corneal refractive surgery and unoperated eyes when strict inclusion criteria were met. Dr. Güell is a consultant to Ophtec BV and Carl Zeiss Meditec AG. No other author has a financial or proprietary interest in any material or method mentioned.

Three-year follow-up of iris-claw phakic intraocular lens implantation for high myopia

To investigate long-term efficacy and safety of an iris-claw phakic intraocular lens (ICPIOL) implantation for high myopia. A consecutive group of 86 eyes in 49 patients with -15.33±3.81 diopters (D) of myopia was implanted with the Artisan ICPIOL (Ophtec), and was evaluated preoperatively and 1, 2, 3 years postoperatively. Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), manifest refraction, intraocular pressure, and complications were evaluated. The implantation was successful in all of 86 eyes. Compared with preoperative data, UCVA, BCVA, and spherical equivalent (SE) were improved significantly (F=513.68, 20.88, 827.65; P<0.01). At 3-year postoperatively, UCVA in 85% eyes was 0.5 or better, in 35% was 0.8 or better; No loss of BCVA was found, 17% gained 1 line, and 59% gained 2 lines or more; SE in 81%, 54% eyes was within ±1.00 D, ±0.50 D of attempted, respectively. At 1-, 2-, 3-year follow-up, the corneal endothelial loss was 3.60%, 5.78%, 7.74%, respectively. There were 2 macular haemorrhages resulted from CNV, and 1 ICPIOL repositioning due to inappropriate iris capture. No other severe complications occurred. At 3-year follow-up, the implantation of the ICPIOL proved to be safe and effective for the correction of myopia in phakic eyes.

Bilateral giant tear‐associated retinal detachment following Artisan® phakic intraocular lens implantation for correction of moderate myopia

Editor, A 39-year-old man presented with blurred vision in his left eye (LE). He had a history of bilateral Artisan® phakic intraocular lens (PIOL) implantation for correction of − 6.00 D in the RE and − 7.50 D LE (axial length: 25.50 mm RE, 25.83 mm LE), carried out 2 months earlier. According to his records, preoperative fundus examination had been unremarkable and the procedure had been performed without complications. On examination, visual acuity (VA) was 20/25 RE and 20/20 LE. Anterior segment examination was unremarkable and intraocular pressure (IOP) was within normal limits. Fundoscopy revealed a superior macula-on retinal detachment (RD) arising from a giant retinal tear (GT) at 11–4 o’clock with an inverted posterior flap in the LE and a normal fundus with no posterior vitreous detachment in the RE. A 20-gauge pars plana vitrectomy was performed (Fig. 1), endophotocoagulation was applied to the edges of the GT and 5000 centistokes of silicone oil (SO) were used as tamponade. A macula-on, giant tear-associated retinal detachment seen during vitrectomy in the left eye. Note that the intraoperative view was relatively clear through the Artisan® phakic intraocular lens. Two weeks later, the patient complained of visual deterioration in the RE (Fig. 2) and fundoscopy showed a GT-associated, superior macula-on RD almost identical to that in the LE. A vitrectomy with endolaser and SO tamponade was performed in the RE. Right eye before surgery for retinal detachment. Silicone oil was removed 3 months after each surgery. Fundoscopy at the 6-month follow-up demonstrated an attached retina in both eyes. Visual acuity was 20/30 LE and 20/40 RE. Until recently, PIOL implantation has been considered to represent one of the few surgical options (along with clear-lens extraction) for correcting high myopic errors (> − 12 D). Interestingly, over the last decade the scientific pursuit of correction of moderate myopia using PIOLs in selected patients has gained increasing numbers of supporters. Since the US Food and Drug Administration (FDA) approval of the iris-claw Artisan®/Verisyse™ PIOL (OPHTEC BV (Netherlands) and Advanced Medical Optics, Inc. (AMO)) in 2004, its use has extended beyond the limits of multicentre trials to ‘routine’ refractive practice. Several studies regarding the safety and complication rates of the Artisan®/Verisyse™ PIOL have reported poor centration, glare or haloes, pupil ovalization, mild corneal oedema and RD as possible complications (Hernaez-Ortega & Soto-Pedre 2004; Tahzib et al. 2007; Guell et al. 2008). In eyes in which PIOLs are implanted to correct high myopia, the risk for RD would be, in the first instance, attributable to the myopia itself because a correlation between severe myopia and RD has been previously confirmed (Schepens & Marden 1966). In addition, the risk for RD in eyes implanted with phakic lenses for the correction of high myopia is reported to be higher in eyes with an axial length > 30.24 mm (Ruiz-Moreno et al. 2006). An earlier study (Ruiz-Moreno et al. 1999) reported an incident of RD of 4.8% in eyes implanted with anterior chamber PIOLs compared with 0.71–2.3% in patients with myopia and no previous intraocular surgery. The occurrence of a bilateral RD with GTs has been previously reported following LASIK (laser-assisted in situ keratomileusis) (Hernaez-Ortega & Soto-Pedre 2003), as well as after posterior chamber PIOL implantation (Navarro et al. 2005). Additionally, a case of unilateral GT-associated RD after Artisan® iris-claw PIOL implantation has been reported (Hernaez-Ortega & Soto-Pedre 2004). It was argued that the polymethylmethacrylate (PMMA)-induced inflammation in conjunction with an additional surgical trauma-associated inflammatory response may have led to tissue damage and subsequent giant retinal tear formation. In our case, the bilateral nature of the complication, the short period between the Artisan® PIOL implantation and occurrence of RD, the moderate myopia without significantly high axial length and the unremarkable preoperative fundus examination in a young healthy individual with a negative family history for both Marfan and Stikler syndromes comprise the main factors leading to high suspicion of an aetiological correlation between the Artisan® PIOL implantation and the observed complication. We believe that the combination of an inflammatory response, as previously mentioned, with perioperative IOP fluctuations may play a role in the underlying pathophysiological mechanism. It should also be noted that intraoperative vitrectomy manipulations were performed without difficulty through the Artisan® PIOL in both eyes (Fig. 1). To the best of our knowledge, this is the first report of a bilateral GT-associated RD following bilateral Artisan® PIOL implantation. Further studies are required to confirm this possible association. However, although the incidence is rare and the exact pathophysiology not fully elucidated, pretreatment counselling should include a discussion outlining the possible risk of RD in patients planning an Artisan® PIOL implantation for correction of myopia.

Long-term Change in Corneal Endothelium After Iris-fixed Phakic Intraocular Lens Insertion

Purpose: To investigate long-term endothelial changes in phakic eyes implanted with iris-claw phakic intraocular lens (IOL) (Artisanlens Ophtec, Groningen, Netherlands) and to identify the associated factors. Methods: Thirty-one eyes of 18 patients underwent Artisan phakic IOL implantation and were followed up for over 1 year. The authors retrospectively examined the endothelial cell density, percentage of hexagonal cells and coefficient of variation using the result of non-contact specular microscope. Results: The mean endothelial cell loss was 0.9% at 23.99.44 months of the mean follow-up period. There was no statistically significant decrease in endothelial cell density (p=0.445). There was no statistically significant change in pleomorphism and polymegathism of the endothelial cells after the surgery. There was no statistically significant correlation between endothelial cell loss and anterior chamber depth (=0.0488, p=0.377). Conclusions: No clinically significant endothelial damage occurred after iris-claw phakic IOL implantation. However, special attention should be given to patients with shallow anterior chamber depth for iris-claw phakic IOL insertion to avoid unintended endothelial damage and long-term endothelial checkups using a specular microscope are critical for long-term protection of endothelial cells.

Urrets-Zavalia Syndrome Following Iris-claw Phakic Intraocular Lens Implantation

To report a patient who had a fixed and dilated pupil after uneventful iris-claw phakic intraocular lens (IOL) implantation. A 27-year-old woman with bilateral high myopia underwent bilateral implantation of iris-claw phakic IOLs. No specific ocular findings were noted until postoperative week 1. Intraocular pressure (IOP) was within normal range in both eyes after surgery. At postoperative week 2, the right pupil was normal, but the left pupil was fully dilated and non-reactive to light, accommodative effort, and 0.125% and 2% pilocarpine. Best spectacle-corrected visual acuity was 1.0, and IOP was 13 mmHg in the left eye. There was no history of perioperative mydriatic use. Urrets-Zavalia syndrome, unrelated to IOP elevation, occurred after uneventful phakic IOL implantation. Clinicians performing phakic IOL implantation should be aware of this complication.

Long-Term Complications of Iris-Claw Phakic Intraocular Lens Implantation in Weill-Marchesani Syndrome

This study was designed to report the long-term complications of iris-claw phakic intraocular lens implantation in a patient with Weill-Marchesani syndrome. Case report and literature review. A 26-year-old man with a history of glaucoma had bilateral phakic lens implantation for high myopia 10 years previously. Two years later, the left implant dislocated and was repositioned. Slit-lamp examination of both eyes revealed phakic implants of the iris-claw variety. There were moderate iridocorneal adhesions in the areas in which the lens haptics pinched the iris in both eyes and moderate epithelial and stromal edema over the temporal one-third of the left cornea. The crystalline lenses were clear with 3+phacodonesis OU. Dilated fundus examinations revealed bilateral severe optic nerve cupping. Crystalline lens diameters were measured at 7.5mm in the right eye and 8 mm in the left. Anterior chamber depths were 2.63 mm OD and 2.40 mm OS. Specular microscopy revealed central endothelial cell counts of 1133 and 587 cells/mm OD and OS, respectively. Axial lengths were 23.3 mm OD and 25 mm OS. Gonioscopic examination revealed bilateral angle closure with marked peripheral anterior synechiae. Based on our findings of short stature, shortened and thickened fingers, relatively normal axial length, microspherophakia, high myopia, and glaucoma, we diagnosed the patient with Weill-Marchesani syndrome. Iris claw-lens phakic lenses may be an effective surgical alternative to correct high myopia in select patients; however, it may produce long-term complications in eyes with specific features.

Experience with the Artisan phakic intraocular lens in Asian eyes

To investigate the efficacy and safety of implantation of an iris-claw phakic intraocular lens (PIOL), Artisan Myopia, in Asian eyes. Minamiaoyama Eye Clinic, Tokyo, Japan. Forty-four eyes of 32 Japanese patients and 1 Korean patient with high myopia had Artisan Myopia lens implantation to correct their refractive errors. Lens models, 5/8.5 or 6/8.5 (optic diameter/overall diameter), were chosen as standard lens model. A smaller lens model (5/7.5-Artisan Myopia Small) was implanted in eyes with corneal diameter less than 11.0 mm. Postoperative examinations were performed on 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years after surgery. Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), manifest refraction, corneal endothelial cell counts, intraocular pressure, and complications were evaluated. Artisan Myopia Small lenses were implanted in 4 eyes (9.1%) and 8.5 mm diameter lenses were implanted in 40 eyes. Preoperative UCVA (logMAR) improved from 1.57 to 0.09 at 1 month after surgery and no regression was observed thereafter. Postoperative manifest refraction was -1.02 +/- 0.87 D (-3.25 to -0.00 D), and within 1.0 D in 20 eyes (55.6%), within 2.0 D in 32 eyes (88.9%) at 1 month after surgery, and stable during the follow-up period. The final BCVA decreased 2 lines in 2 eyes (4.5%) due to progression of age-related cataract. No serious complications such as angle closure or progressive endothelial cell loss were observed. Implantation of an Artisan iris-claw PIOL implantation may be a safe and effective procedure for Asian eyes.