|Year : 2012 | Volume
| Issue : 2 | Page : 199-203
Evaluation of sterile uveitis after iris-fixated phakic intraocular lens implantation
Mohamadreza Sedaghat1, Mehran Zarei-Ghanavati1, Mohammad-Reza Ansari-Astaneh1, Virag Patel2, Shameema Sikder3
1 Khatam-Al-Anbia Eye Hospital, Mashhad University of Medical Sciences, Mashad, Iran
2 University of Nevada, School of Medicine, Las Vegas, Nevada, USA
3 Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD, USA
|Date of Web Publication||21-Apr-2012|
Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Purpose: To evaluate the clinical features, and visual outcomes of sterile uveitis after iris-fixated phakic intraocular lens implantation (pIOLs) (Artisan-Artiflex® and Verisyse-Veriflex® ).
Material and Methods: In this retrospective non-comparative case series, the medical records of 117 eyes implanted with Artisan-Artiflex® (Ophtec BV, Groningen, Netherlands) and Verisyse-Veriflex® (AMO, Santa Ana, CA) iris claw phakic IOLs were analyzed for postimplantation sterile uveitis. The mean age of the 87 patients included in the study was 27.2±7.4 years. Of these patients, 56 (64.3%) were men and 31 (35.6%) were women. Patient age, gender, IOL brand type, refractive error, optic diameter, unilateral vs bilateral implantation, and anterior chamber depth were analyzed. Features of uveitis, uncorrected and best corrected visual acuity (VA) at presentation and at follow-up visits were examined. The mean follow-up time was 14.6 months (range: 6-37 months).
Results: Clinically significant uveitis was observed in 12 of 117 eyes (10.3%) in a total of ten patients. Of these ten patients, four (40%) were women and six (60%) were men, and the mean age was 25.1±5.3 years (range: 18-36 years). Among those with bilateral implantation, 6.9% of patients developed bilateral uveitis, while 13.8% (4 of the 29 implanted bilaterally) developed unilateral uveitis. Foldable pIOL implantation was the only variable associated with the development of uveitis (P=.03).
Conclusion: Although the prognosis is usually benign, sterile uveitis occurred in 10.3% of patients after iris-fixated pIOL implantation. The implantation of a foldable pIOL was the only variable associated with sterile uveitis. Appropriate medical management can be effective treatment, without the need for pIOL replacement.
Keywords: Artiflex® , Artisan® , Complications, Phakic Intraocular Lens, Uveitis, Veriflex® , Verisyse®
|How to cite this article:|
Sedaghat M, Zarei-Ghanavati M, Ansari-Astaneh MR, Patel V, Sikder S. Evaluation of sterile uveitis after iris-fixated phakic intraocular lens implantation. Middle East Afr J Ophthalmol 2012;19:199-203
|How to cite this URL:|
Sedaghat M, Zarei-Ghanavati M, Ansari-Astaneh MR, Patel V, Sikder S. Evaluation of sterile uveitis after iris-fixated phakic intraocular lens implantation. Middle East Afr J Ophthalmol [serial online] 2012 [cited 2019 Jun 26];19:199-203. Available from: http://www.meajo.org/text.asp?2012/19/2/199/95249
This work has also been presented as a poster at the 2009 XXVII Congress of the ESCRS - Barcelona 2009
| Introduction|| |
Moderate to high myopia (−6.0D to −20.0D) can be surgically corrected by phakic intraocular lens (pIOL) implantation or laser corneal ablation. A recent review of three randomized controlled trials that examined a total of 228 eyes concluded that pIOL implantation caused less loss of best corrected visual acuity (BCVA) at 12 months postoperatively and appeared to produce better contrast sensitivity than laser excimer surgery in moderate to high myopia patients. ,,
Iris-fixated pIOL include Artisan® (Ophtec B.V., Groningen, Netherlands) and Verisyse® (Advanced Medical Optics, Santa Ana, CA), which are similar lenses from two different manufacturers. Foldable pIOL (Artiflex® or Veriflex® ) have also been developed featuring a hybrid design of a 6-mm silicone optic and PMMA haptics.
Postoperative sterile uveitis after iris-fixated pIOL has been reported in previous studies.  However, prognosis, ocular manifestations, and risk factors have not undergone adequate discussion to establish a consensus on the prevention and management of this complication.
The objective of this study was to retrospectively report the incidence, risk factors, clinical features, and visual outcomes of sterile uveitis in Artisan-Artiflex® and Verisyse-Veriflex® iris-fixated intraocular lens implantations.
| Materials and Methods|| |
In this retrospective case series, the medical records of 87 patients (117 eyes) who were consecutively implanted with iris-fixated phakic IOLs (Artisan-Artiflex® and Verisyse-Veriflex® ) to correct high hyperopia or high myopia and/or astigmatism were evaluated. Consent was obtained from each patient prior to treatment. Among the participants, 57 (64.8%) were men and 31 (35.2%) were women. The mean age of the patients was 27.2±7.4 years. Each patient had at least a 6-month postoperative follow-up, with the mean follow-up being 14.6 months (range: 6-37 months). All the surgeries were performed by the same surgeon (MS). Informed consent was obtained from all patients. This investigation was approved by the review board/ethics committee of the Mashhad University of Medical Sciences Eye Research Center and patients were treated as per the Helsinki Declaration.
The inclusion criteria for the study were as follows: age ranging from 18 to 50 years, stable manifest refraction for at least 1 year, an anterior chamber depth greater than 2.8 mm, and an endothelial cell count of ≥2200 cells/mm  . The exclusion criteria were: anterior segment pathologic features, abnormal iris, abnormal pupil function, history of uveitis, evidence of cataract or glaucoma, or presence of systemic disease (e.g., diabetes mellitus).
Artisan-Artiflex® (Ophtec B.V., Groningen, Netherlands) and Verisyse-Veriflex® (Advanced Medical Optics, Santa Ana, CA) lenses were used in this study. Intraocular pilocarpine 2% was used prior to surgery. Under peribulbar anesthesia, two stab incisions were made at the 10 o'clock and 2 o'clock position. The pupils were constricted with an intracameral injection of acetylcholine (Miochol™, Novartis Ophthalmics). After injection with an ophthalmic viscosurgical device (OVD) (Cellugel™; Alcon, Inc.), a clear corneal incision was made at the 12 o'clock position. For nonfoldable lenses, the incision was 5.2 or 6.2 mm, whereas an incision of 3.2-mm was used for the foldable IOL. In toric Artisan® lens implantation cases, the incision site was altered according to the axis of astigmatism. After insertion of the lens into the anterior chamber it was fixed to the iris with an enclavation needle (Ophtec, Inc.). Additionally, a peripheral iridectomy was performed at the 12 o'clock position and the OVD was washed out. The incisions were subsequently secured with interrupted 10-0 nylon sutures. Topical ciprofloxacin 0.3% and betamethasone 1% were used four times and six times a day, respectively, for 1 week. Betamethasone was then tapered over a 5-week period.
Scheduled postoperative examinations were performed at intervals of 1 day, 1 week, 1 month, 3 months, and 6 months. Additional examinations were accommodated at the request of the patient. Examination protocols included fundus and slit-lamp examination, evaluation of uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and intraocular pressure.
Clinically significant uveitis was associated with the following signs: presence of white blood cells in the anterior chamber with evidence of flare, and at least one of the following: anterior or posterior synechiae, presence of a fibrin membrane over the IOL or pupil, IOL keratic precipitates, and evidence of hypopyon.
Treatment of anterior uveitis consisted of oral prednisone tablets (1 mg/kg/day) for 1 week and betamethasone ophthalmic drops to be applied every 2 hours when awake. After clinical improvement, steroid therapy was tapered to complete cessation over a 1-month period. In addition, atropine 1% ophthalmic drops were prescribed three times a day for symptomatic relief.
Student's t and Chi-square tests were used for statistical analyses with SPSS® software (SPSS Inc., Chicago). The results were expressed as mean±SD. P<.05 was considered statistically significant.
| Results|| |
Clinically significant uveitis was detected in 12 of 117 eyes (10.3%) in a total of ten patients [Table 1]. Among these ten patients, four (40%) were women, and six (60%) were men. The mean age was 25.14±5.3 years (range: 18-34 years).
|Table 1: A summary of the preoperative data, presentation features and the final results of the patients with uveitis after pIOL implantation. (Aqueous flare and Anterior chamber reaction were observed in all cases)|
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Of the 87 patients, 29 had successive bilateral pIOL implantation. Two of the 29 patients (6.9%) developed uveitis bilaterally, while four (13.8%) developed only unilateral uveitis (one patient in the first operated eye and the others in the second eye). Among the patients with unilateral implantation, 4 of the 58 (6.9%) developed subsequent uveitis.
Uveitis occurred in 2 of 8 hyperopic eyes (25%). Among the other cases: 10 of 109 (9.1%) myopic eyes were implanted with 4 of a total of 84 (4.7%) Artisan® , 4 of 15 (26.6%) Artiflex® , 1 of 3 (33.3%) Verisyse® , and 1 of 7 (14.2%) Veriflex® lenses.
No patient had a previous history of intraocular inflammation or ocular surgery other than prior pIOL implantation. Past medical history and general physical exams did not reveal any systemic risk factors. Laboratory evaluations were not incorporated into the screening protocols. The Chi-square test showed that gender, pIOL optic diameter, previous pIOL implantation, and hyperopic or myopic correction did not significantly increase the risk of developing postoperative uveitis (P>.05) However, patients with foldable pIOL implantation had a significantly greater risk of developing uveitis in comparison to those with non-foldable pIOL (P=.03) [Table 2]. Age and anterior chamber depth were analyzed as risk factors using the independent-samples Student's t test. These calculations did not reveal a significant association with postoperative uveitis (P>.05) [Table 3].
|Table 2: Comparing possible risk factors between patients with and without uveitis using the chi-square test|
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|Table 3: Comparing possible risk factors between patients with and without uveitis using independent-samples t test|
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The average day of presentation was 4.1±3.2 days after surgery (range: 1-10). Presenting symptoms, in order of frequency, were as follows: decreased vision (11 eyes, 84.6%), red eye (6 eyes, 46.1%), and pain (2 eyes, 15.3%). Presenting signs, in order of frequency, were as follows: anterior chamber reaction and aqueous flare (13 eyes, 100%), fibrin membrane coating the IOL (11 eyes, 84.6%), posterior synechiae (7 eyes, 53.8%), hypopyon (5 eyes, 38.4%), and increased intraocular pressure (1 eye, 7.6%) [Figure 1]. Open-angle glaucoma occurred in one hyperopic eye 1 month after recovery from uveitis and was controlled by topical medication. Closed-angle glaucoma did not occur in any cases of uveitis due to patency established with a surgical iridectomy during the initial pIOL implantation.
|Figure 1: Patient number 8: Veriflex® lens implantation right eye: Severe inflammation with 0.5-mm hypopyon 3 days after surgery, two months after treatment, best corrected visual acuity was 8/10|
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In reviewing the treatment protocol, it was found that inflammation subsided in less than 1 month in all cases except for patient 10, who showed signs of uveitis flare-up 1  / 2 months after full recovery. In all patients, BCVA returned to a pre-uveitis level after inflammation subsided. Rhegmatogenous retinal detachment (RRD) was noted in patient 5 some months later. Clinical cystoid macular edema (CME) did not occur in any patient. No patient required IOL exchange. The most common sequelae noted was IOL pigment deposit (6 eyes, 46.1%) [Figure 2].
|Figure 2: Patient number 8: Artiflex® lens implantation left eye: Uveitis presenting at 10 days after surgery, two months after treatment, best corrected visual acuity was 9/10, with moderate phakic intraocular lens deposits|
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| Discussion|| |
Phakic IOL implantation generally achieves satisfactory refractive outcomes, but some postoperative complications are known to arise.  Iris-fixated-pIOL-associated uveitis has been reported in previous studies with an incidence ranging from 0.0% to 4.53%. , Alio et al. reported inflammation at a rate of 7% (4/57 cases). Furthermore, anterior uveitis presented with fibrin membrane formation and with associated small sterile hypopyon during the first postoperative week.  Asano-Kato et al. reported one case among 44 (2.3%) of uveitis with severe fibrin formation on postoperative day 1.  Menezo et al. reported an incidence of 6.5% for diffuse Artisan® pigment deposits not associated with uveitis or other significant complications.  Moshirfar et al. reported the outcomes of Artisan® /Verisyse® pIOL after a 2-year follow-up and reported one patient (1.2%) with increased cells and flare in the aqueous that persisted for 1 month postoperatively.  Stulting et al. reported 3 patients among 1179 cases of Artisan® /Verisyse® myopic pIOL implantation that required IOL explantation due to inflammatory responses.  Their 3-year study, however, provided no further clarification regarding the degree of uveitis.
The pathogenesis of uveitis after pIOL implantation is still obscure but may be related to an inflammatory reaction caused by perioperative and postoperative mechanical irritation of the iris. It is possible to detect chronic subclinical inflammation with a laser flare-cell meter after implantation of pIOLs.  This observation is a consideration for future study, and may represent an operative screening tool for developing uveitis.
We report an anterior uveitis incidence rate of 10.3%, a value well above previous reports. One explanation for the higher rate in our sample compared to previously published data may be the differences in patient population. The subjects were primarily Caucasians with predominantly brown-colored eyes. A dark iris releases more pigment during surgery and is thus more prone to postoperative inflammation. Perhaps postoperative steroid use should empirically be increased in patients with darker color irides to decrease the incidence of uveitis. Alternatively, a short course of oral steroids could be used, especially in cases of second eyes when uveitis was noted after the first eye. Iris trauma occurring during the surgery may also be a significant risk factor for developing postoperative uveitis. While surgical technique and experience may also account for a higher incidence, our study examined surgeries performed by a single highly-experienced surgeon (MS). Given the results of our study, it may be more appropriate to perform a laser iridectomy preoperatively, with adequate time for resolution of associated pigment release and inflammation, before pIOL implantation.
The higher incidence may have been due to our lenient exclusion criteria. We did not exclude patients with a history of uveitis after pIOL implantation from proceeding with a second eye surgery. We discovered that patients with foldable pIOL implantation had a higher risk for uveitis. It is possible that the silicon component of the foldable pIOL is less biocompatible than the PMMA plastic component used in the non-foldable pIOL.
It also logically seems that uveitis should be more common in hyperopic patients as they have shallower anterior chambers and are thus more prone to iris trauma by a pIOL. Although this was the case in our study, we could not confidently validate our findings due to the small sample size.
Due to similar manufacturing processes for both pIOLs used in this study, it is assumed that there are no differences in the rates of uveitis between Artisan® and Verisyse® or between Artiflex® and Veriflex® . This assumption is supported by patient number 5, who ultimately presented with bilateral uveitis after a right eye Artisan® implant and later a left eye Verisyse® implant.
The prognosis of anterior uveitis is relatively benign. Park et al. reported one case of recurrent laser iridotomy site occlusion after pIOL (Visian ICL™) implantation.  In our case series, no obstruction of surgical iridectomy was detected, and we consequently suggest that surgical iridectomy or preoperative laser iridectomy is a prudent consideration during implantation to prevent closed-angle glaucoma.
There are some shortcomings in our study. We did not include laboratory evaluation during initial screening; for example, we did not test for familial predispositions (e.g., HLA-B27) and autoimmune diseases. Exposure to certain infectious agents may sensitize the immune system and cause increased susceptibility to postoperative inflammation. Visualization of the anterior segment during postoperative exams may also be of utility. Optical coherence tomography (OCT) imaging can demonstrate the area of friction in the anterior vault and help determine if mechanical etiology plays a role. We also suspect that surgical experience with the enclavation technique is an inherent risk factor and that it is, therefore, a variable for future study. Finally, given the small sample size of hyperopes in our patient population, we could not meaninfully compare the incidence of uveitis between hyperopic and myopic presentation.
In conclusion, sterile uveitis is a relatively common complication after iris-fixed pIOL implantation. Although the presenting signs are fulminant, prognosis is usually benign. Many risk factors were investigated; however, our results indicate that foldable pIOL implantation was the only statistically significant association. Medical treatment was found to be effective, and no patient required explantation of the pIOL.
| Acknowledgment|| |
This study was supported by the Eye Research Center; Mashhad University of Medical Sciences, Iran. No author has a financial or proprietary interest in any material or method mentioned. This investigation was approved by the review board/ethics committee of the Mashhad University of Medical Sciences Eye Research Center and patients were treated under the Helsinki Declaration
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]