- Email: [email protected]
Iridocyclitis associated with angle-supported phakic intraocular lenses
J CATARACT REFRACT SURG - VOL 32, JUNE 2006
Iridocyclitis associated with angle-supported phakic intraocular lenses Antonio Leccisotti, MD, PhD
PURPOSE: To evaluate incidence, features, risk factors, and prognosis of iridocyclitis after anglesupported phakic intraocular lens (IOL) implantation. SETTING: Private practice, Siena, Italy. METHODS: This retrospective analysis comprised 356 consecutive eyes of 212 patients. In myopic eyes, the ZSAL-4 IOL (205 eyes of 125 patients) or the ZSAL-4 Plus IOL (106 eyes of 63 patients) was used. In hyperopic eyes (45 eyes of 24 patients), the Type 54 IOL was implanted. Haptic posterior angulation was 19 degrees (ZSAL-4), 23 degrees (ZSAL-4 Plus), and 14 degrees (Type 54). RESULTS: Clinically significant iridocyclitis occurred in 11 eyes (3.1%) of 11 patients. Mean patient age was 37.3 years G 9.4 (SD). Sixty-four percent were male (odds ratio [OR], 3.0; 95% confidence interval [CI], 0.8 to 7.4, not statistically significant). Iridocyclitis was observed in 4.4% of hyperopic eyes (OR, 1.6; 95% CI, 0.3 to 7.4; not statistically significant) and in 2.9% of myopic eyes. In myopic eyes, it followed the implantation of ZSAL-4 IOL in 3.9% of eyes (OR, 4.1; 95% CI, 0.5 to 33.6; not statistically significant), and of ZSAL-4 Plus IOL in 1%. Mean time from surgery was 8.5 G 10.6 months). Presentation included aqueous flare (100%), posterior synechiae (82%), blurred vision (82%), redness (36%), pain (27%), IOL precipitates (18%), and angular synechiae (9%). Only 1 patient had recurrences, leading to IOL explantation and cataract surgery. After topical therapy, best spectacle-corrected visual acuity was fully recovered in 9 of 11 eyes. CONCLUSION: Iridocyclitis can occur months or years after the implantation of angle-supported phakic IOLs. No statistically significant risk factors were identified. Functional prognosis is generally good. J Cataract Refract Surg 2006; 32:1007–1010 Q 2006 ASCRS and ESCRS
Angle-supported phakic intraocular lenses (pIOLs) are an effective option for the correction of high ametropias.1–3 After their implantation, iridocyclitis was observed in as many as 4.5% of eyes in an earlier series,1,2,4 but the incidence and prognosis of this complication has received little attention in the literature since the introduction of new IOL models. In the present study, a series of eyes implanted with an angle-supported was retrospectively evaluated to assess the
Accepted for publication September 12, 2005. From the Ophthalmic Surgery Unit, Casa di Cura Rugani, Siena, Italy. The author has no financial or proprietary interest in any material or method mentioned. Reprint requests to Antonio Leccisotti, MD, PhD, Piazza V Bersaglieri 2, 53100 Siena, Italy. E-mail: [email protected]. Q 2006 ASCRS and ESCRS Published by Elsevier Inc.
incidence, features, and prognosis of clinically significant iridocyclitis and to identify possible risk factors. PATIENTS AND METHODS The charts of all patients who had angle-supported IOL implantation to correct myopia or hyperopia by 1 surgeon (A.L.) between January 2001 and January 2005 were evaluated. Inclusion criteria were age between 21 and 48 years, subjective contact lens intolerance, best spectacle-corrected visual acuity (BSCVA) of 0.2 or better, anterior chamber depth greater than 3.0 mm including corneal thickness (by ultrasound biometry), endothelial cell density greater than to 2400 cell/mm2, and horizontals corneal diameter (‘‘white-to-white,’’ measured by computed a videokeratographer [Keratograph, Oculus]) between 11.4 mm and 12.6 mm. Primary corneal refractive procedures had been ruled out because of a high refractive error and/or reduced corneal thickness, measured by ultrasound pachymetry. Preoperative exclusion criteria were crystalline lens opacities, glaucoma or ocular hypertension, diabetic retinopathy, and ocular inflammatory disease. Postoperative exclusion criteria were ocular inflammation due to an undersized IOL, moving in the anterior chamber. Corneal endothelium was evaluated by 0886-3350/06/$-see front matter doi:10.1016/j.jcrs.2006.02.030
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IRIDOCYCLITIS WITH ANGLE-SUPPORTED PHAKIC IOLS
a noncontact Robo Pachy specular microscope (Konan) for cell density (cells/mm2). The minimum follow-up was 6 months. Slitlamp microscopy, applanation tonometry, and dilated fundoscopy were also performed. An informed consent was provided by all patients. Two hundred twelve patients (356 consecutive eyes) were ultimately included in the study. Mean age was 34.6 years G 7.2 (SD), (range 21 to 48 years). Eighty-one of 212 patients (38%) were men. In myopic eyes, the ZSAL-4 (205 eyes of 125 patients) and the ZSAL-4 Plus (106 eyes of 63 patients) planoconcave, poly(methyl methacrylate) (PMMA) single-piece IOLs were used. These IOLs (Morcher GmbH) are manufactured in 3 overall diameters of 12.5, 13.0, and 13.5 mm, in powers from ÿ5 to ÿ24 diopters (D), and with a total optical zone of 5.5 mm (ZSAL-4) and 5.8 mm (ZSAL-4 Plus); the haptics are z-shaped and posteriorly angulated at 19 degrees (ZSAL-4) and 23 degrees (ZSAL-4 Plus). The ZSAL-4 Plus IOL is an evolution of the ZSAL-4 model and is characterized by longer and more flexible haptics, aiming at decreasing compression forces against angle structures, hence, at reducing haptics-related complications such as pupil ovalization and iridocyclitis.5 In the 45 hyperopic eyes (24 patients), the Type 54 biconvex single-piece PMMA IOL was implanted. This IOL is released in 3 overall diameters of 12.5, 13.0, and 13.5 mm, in powers from C4 to C20 D, and with a total optical zone of 5.0 mm; the haptics are inversely z-shaped and posteriorly angulated at 14 degrees.6 The IOL power was calculated by the van der Hejde formula.7 The overall IOL diameter was calculated by adding 1.0 mm to the horizontal corneal diameter. My surgical technique has been described.8 Briefly, after peribulbar anesthesia, a sclero-corneal 5.5 mm 3.0 mm tunnel (along the steepest meridian on the superior 180 degrees) is made and then the anterior chamber is filled with an ophthalmic viscosurgical device (OVD). A peripheral iridectomy is performed through a separate superior sideport by the Hoffer9 technique (scissor cut followed by aspiration of pigment layer). The lens is inserted, OVD is irrigated out and the wound is closed by 1 or 2 single 10-0 nylon sutures. Ciprofloxacin 0.3% (Oftacilox) and dexamethasone 0.1% (Visumetazone) eyedrops were used 4 times a day for 10 days, after which diclofenac sodium eyedrops (Voltaren) were started
4 times a day for 2 weeks. The short steroid course was chosen to avoid steroid-related ocular hypertension, observed in 18% of myopic eyes having pIOL implantation.8 Follow-up visits were made at 1, 7, and 14 days; 1, 2, 4, 8, 12, 18, and 24 months; and on patient demand if a problem was suspected. All visits comprised uncorrected visual acuity (UCVA) and BSCVA, undilated slitlamp evaluation, iridectomy evaluation, and tonometry. Dilated slitlamp examination and fundoscopy, gonioscopy, and endothelial microscopy were added at 2, 8, 12, 18, and 24 months. Iridocyclitis was defined as clinically significant when slitlamp examination revealed at least 1 of the following signs: endothelial precipitates, anterior or posterior synechiae, and IOL precipitates. Isolated aqueous flare was considered significant only when presenting more than 15 days after surgery and if associated with at least 1 of the following symptoms: decreased BSCVA, ocular or periocular pain, and injection of the perilimbal blood vessels. In patients with iridocyclitis, general health status was evaluated in all patients by anamnesis, complete blood count, eritrosedimentation rate, serum evaluation of antinuclear antibody, angiotensin converting enzyme, rheumatoid factor, blood culture, human leucocyte antigen (HLA) testing, venereal disease research, purified protein derivative, chest and sacroiliac radiography, and dermatological examination. Statistical analysis was performed by StatView (Abacus Concepts, Inc.). Odds ratios and 95% confidence intervals (CIs) were calculated by CIA software (BMJ). For 95% CI of the difference of the means, statistical significance (P!.05) was identified when the interval did not include the null value. For odds ratios, statistical significance (P!0.05) was identified when both 95% CI limits were superior to 1.0.
RESULTS
Clinically significant iridocyclitis occurred in 11 eyes (3.1%) of 11 patients (Table 1). No bilateral cases were observed. Mean age at IOL implantation was 37.2 G 9.5 years, range 22 to 48 years); the difference with the whole series of operated eyes is not statistically significant (95% CI for the
Table 1. Main features at presentation and prognosis of iridocyclitis associated with angle-supported phakic IOLs (11 eyes of 11 patients).
Patient No.
Age (y) at Surgery
Time After Surgery (Mo)
Presentation*
Sequealae
1 2 3 4 5 6
22 38 28 45 44 48
1 1 4 26 13 3, 6, 10
PSCC, DV PSC, DV PSC, redness, pain PSCCC, IP, DV PSCC, IP, DV, pain PSCCC, DV, redness
7 8 9 10 11
42 48 25 29 40
8 31 2 3 1
PSC PSCCCC, DV DV, redness, pain ASC, DV PSCC, DV, redness
PSC None None PSCCC, DV (ÿ0.2) PSC, DV (ÿ0.1) PSCCC, cataract, DV (restored after cataract surgery) None PSCC None None PSC
AS Z angular synechiae; DV Z decreased vision; IP Z intraocular lens precipitates; PS Z posterior synechiae (C Z less than 90 degrees; CC Z 90 degrees to 180 degrees; CCC Z 181 degrees to 360 degrees) *Aqueous flare was observed in all cases.
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difference between means ÿ1.8 to 7.0 years). Seven of 11 patients (64%) were male. Iridocyclitis was observed in 2 of 45 hyperopic eyes (4.4%) and 9 of 311 (2.9%) myopic eyes after the implantation of 2 of 45 Type 45 IOLs (4.4%), 8 of 205 ZSAL-4 IOLs (3.9%), and 1 of 103 ZSAL-4 Plus IOL (1%). The involved eye was the first implanted in 5 cases, the second implanted in 2 cases, and the only 1 implanted in 4 cases. Odds ratios for possible risk factors (male sex, hyperopia, first implanted eye, IOL model) were not statistically significant. Mean time from surgery was 8.5 G 10.6 months, (range 1 to 31 months; 95% CI, 1.3 to 15.6 months). In no patient was general risk factors such as a present or past rheumatological, dermatological, or infectious disease or an HLA-B27, HLA-A29, or HLA-B51 genotype were identified. Presenting symptoms were blurred vision in 9 eyes (82%), redness in 4 eyes (36%), and subtle pain in 3 eyes (27%). Signs were represented by cells and aqueous flare in 11 eyes (100%), posterior synechiae in 9 eyes (82%), small IOL precipitates in 2 cases (18%), 1 o’clock angular synechia (1.0 mm from an IOL footplate) in 1 case (9%) (Figures 1 and 2). No endothelial precipitates were observed. Intraocular lens position was normal, and no pupil ovalization was noted. At gonioscopy, no footplate appeared to erode into the uveal tissue. Only 1 patient had recurrences (2 episodes), leading to anterior and posterior subcapsular cataract, thus requiring IOL explantation, phacoemulsification, and in-the-bag IOL implantation. Post-phacoemulsification course was uneventful, and no further recurrences were observed. In all patients, resolution of active inflammation was observed after topical treatment (atropine 1% eyedrops
twice a day and dexamethasone 0.1% eyedrops every second hour when awake, tapered after improvement). Steroid-induced ocular hypertension (36 mm Hg) was recorded (patient 8) in a highly myopic eye (ÿ23 D); steroid suspension after healing was followed by recovery of normal intraocular pressure. After healing, preinflammatory BSCVA was fully recovered in 9 of 11 eyes, including the patient having phacoemulsification; in the 2 remaining eyes, BSCVA was reduced from 0.7 to 0.5 and from 0.8 to 0.7, respectively, because of pigment deposits on the anterior capsule. Permanent sequelae consisted of posterior synechiae in 6 eyes (1 in the patient having cataract surgery). No other long-term modifications were observed. In the entire series of operated eyes, mean corneal endothelial cell density variation was ÿ6.16% at 12 months. In eyes with iridocyclitis, cell density was evaluated 3 months after complete healing: compared with preoperative count, mean variation was ÿ9.7% G 4.2%, (range ÿ2% to ÿ17%). In the patient having IOL explantation with cataract surgery, endothelial cell density measured before phakic IOL implantation had decreased by 16% after phacoemulsification.
Figure 1. Iridocyclitis occurred 31 months after ZSAL-4 IOL implantation. At presentation, posterior synechiae were almost at 360 degrees (patient 8).
Figure 2. Eye in Figure 1 after 1 month of topical steroids and atropine with pharmacological mydriasis. Residual posterior synechiae are seen at the nasal quadrant, and pigment remnants on the crystalline lens.
DISCUSSION
The incidence of iridocyclitis after the implantation of an angle-supported pIOL was 3.1% in the present series. All observed cases were monolateral, more commonly affecting the first or the only implanted eye, and the mean age at surgery in affected patients was 2.7 years older than in the whole series (not statistically significant). The high variability is noteworthy in terms of presenting time after
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surgery, ranging from 1 to 31 months. The minimum follow-up in this series was 6 months, so the study might have underestimated the incidence of this long-term complication. Clinical presentation was in most cases characterized by posterior synechiae. The prognosis is benign, with complete visual recovery in most cases after a single cycle of topical therapy, although permanent visual reduction may result from posterior synechiae and crystalline lens precipitates. Sequelae were more pronounced in older patients. No significant risks factor were identified in our study. However, the main weakness of the present study is represented by the possibility of having missed risk factors due to very limited samples in each subgroup. Odds ratio calculation becomes imprecise when 1 or more terms are small.10 Anterior chamber pIOL-induced iridocyclitis has been observed with angle-supported1,2,6,8,11 and irisfixated IOLs12,13; the incidence ranges from 1% to 7.7%. The prognosis is generally good, and IOL explantation is rarely required.1,6 Excluding the exceedingly rare cases of bacterial endophthalmitis14 and the uncommon case of undersized, movable IOLs,8 its pathogenesis is unclear but most likely related to chronic iris–IOL contact, as observed with pseudophakic anterior and posterior chamber IOLs.15–17 Haptic-angle interaction has been proposed as a possible mechanism, leading to an improvement of haptics in newer models5; however, iris-fixated anterior chamber pIOLs (with no angular support) do induce a similar iridocyclitis in approximately 7% of eyes.12,13 A subclinical iridocyclitis can be detected by a laser flare–cell meter soon after anterior chamber phakic IOL (both models) implantation and even 24 months later.4 This justifies our cases with late presentation. Ultrasound biomicroscopy and optical coherence tomography, although not performed in the present study, can reveal the contact between IOL and uveal tissues,18 as in studies of pseudophakic iridocyclitis15–17 and on pigment dispersion caused by anterior chamber pIOLs.19 This latter syndrome, although not a true uveitis, shares with phakic IOL-induced iridocyclitis some features (pigment, posterior synechiae).20 Iridocyclitis associated with pIOLs and topical steroids may induce cataract, which can be safely removed together with IOL explantation.21 A challenge in biometry is represented by the presence of an anterior chamber IOL; therefore, it is advisable to perform biometry (and file data) before each pIOL implantation. In conclusion, iridocyclitis is not rare after implantation of angle-supported pIOLs, and is usually characterized by a single episode of reduced vision with posterior synechiae, occurring even years after implantation. Topical therapy is generally effective, and IOL explantation is rarely needed. No significant risk factors were identified;
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therefore, all patients receiving these implants should be appropriately counseled and followed indefinitely. REFERENCES 1. Baikoff G, Arne JL, Bokobza Y, et al. Angle-fixated anterior chamber phakic intraocular lens for myopia of ÿ7 to ÿ19 diopters. J Refract Surg 1998; 14:282–293 2. Alio´ JL, de la Hoz F, Pe´rez-Santonja JJ, et al. Phakic anterior chamber lenses for the correction of myopia: a 7-year cumulative analysis of complications in 263 cases. Ophthalmology 1999; 106:458–466 3. Ferreira de Souza R, Forseto A, Nose´ R, et al. Anterior chamber intraocular lens for high myopia: five year results. J Cataract Refract Surg 2001; 27:1248–1253 4. Pe´rez-Santonja JJ, Iradier MT, Benı´tez del Castillo JM, et al. Chronic subclinical inflammation in phakic eyes with intraocular lenses to correct myopia. J Cataract Refract Surg 1996; 22:183–187 5. Pe´rez-Santonja JJ, Alio´ JL, Jime´nez-Alfaro I, Zato MA. Surgical correction of severe myopia with an angle-supported phakic intraocular lens. J Cataract Refract Surg 2000; 26:1288–1302 6. Leccisotti A. Angle-supported phakic intraocular lenses in hyperopia. J Cataract Refract Surg 2005; 31:1598–1602 7. van der Heijde GL. Some optical aspects of implantation of an IOL in a myopic eye. Eur J Implant Refract Surg 1989; 1:245–248 8. Leccisotti A, Fields VS. Clinical results of ZSAL-4 angle-supported phakic intraocular lenses in 190 myopic eyes. J Cataract Refract Surg 2005; 31:318–323 9. Hoffer KJ. Pigment vacuum iridectomy for phakic refractive lens implantation. J Cataract Refract Surg 2001; 27:1166–1168 10. Breslow NE, Day NE. The analysis of case-control studies. Statistical Methods in Cancer Research. Volume 1. Lyon, France, International Agency for Research on Cancer, 1980, 124–246 11. Allemann N, Chamon W, Tanaka HM, et al. Myopic angle-supported intraocular lenses: two-year follow-up. Ophthalmology 2000; 107:1549–1554 12. Alio´ JL, Mulet ME, Shalaby AMM. Artisan phakic iris claw intraocular lens for high primary and secondary hyperopia. J Refract Surg 2002; 18:697–707 13. Saxena R, Landesz M, Noordzij B, Luyten GPM. Three-year follow-up of the Artisan phakic intraocular lens for hypermetropia. Ophthalmology 2003; 110:1391–1395 14. Pe´rez-Santonja JJ, Ruı´z-Moreno JM, de la Hoz F, et al. Endophthalmitis after phakic intraocular lens implantation to correct high myopia. J Cataract Refract Surg 1999; 25:1295–1298 15. Amino K, Yamakawa R. Long-term results of out-of-the-bag intraocular lens implantation. J Cataract Refract Surg 2000; 26:266–270 16. Chen W, Liu Y, Wang N, et al. Comparison of the effects of two types of intraocular lens. Chin Med J 2001; 114:1286–1289 17. Piette S, Canlas OAQ, Tran HV, et al. Ultrasound biomicroscopy in uveitisglaucoma-hyphema syndrome. Am J Ophthalmol 2002; 133:839–841 18. Jime´nez-Alfaro I, Garcı´a-Feijoo´ J, Pe´rez-Santonja JJ, Cuin˜a R. Ultrasound biomicroscopy of ZSAL-4 anterior chamber phakic intraocular lens for high myopia. J Cataract Refract Surg 2001; 27:1567–1573 19. O¨zdal MPC¸, Mansour M, Descheˆnes J. Ultrasound biomicroscopy of pseudophakic eyes with chronic postoperative inflammation. J Cataract Refract Surg 2003; 29:1185–1191 20. Baikoff G, Bourgeon G, Jodai HJ, et al. Pigment dispersion after Artisan phakic intraocular lens: crystalline lens rise as a safety criterion. J Cataract Refract Surg 2005; 31:674–680 21. Alio´ JL, de la Hoz F, Ruiz-Moreno JM, Salem TF. Cataract surgery in highly myopic eyes corrected by phakic anterior chamber angle-supported lenses. J Cataract Refract Surg 2000; 26:1303–1311
J CATARACT REFRACT SURG - VOL 32, JUNE 2006
Iridocyclitis associated with angle-supported phakic intraocular lenses Antonio Leccisotti, MD, PhD
PURPOSE: To evaluate incidence, features, risk factors, and prognosis of iridocyclitis after anglesupported phakic intraocular lens (IOL) implantation. SETTING: Private practice, Siena, Italy. METHODS: This retrospective analysis comprised 356 consecutive eyes of 212 patients. In myopic eyes, the ZSAL-4 IOL (205 eyes of 125 patients) or the ZSAL-4 Plus IOL (106 eyes of 63 patients) was used. In hyperopic eyes (45 eyes of 24 patients), the Type 54 IOL was implanted. Haptic posterior angulation was 19 degrees (ZSAL-4), 23 degrees (ZSAL-4 Plus), and 14 degrees (Type 54). RESULTS: Clinically significant iridocyclitis occurred in 11 eyes (3.1%) of 11 patients. Mean patient age was 37.3 years G 9.4 (SD). Sixty-four percent were male (odds ratio [OR], 3.0; 95% confidence interval [CI], 0.8 to 7.4, not statistically significant). Iridocyclitis was observed in 4.4% of hyperopic eyes (OR, 1.6; 95% CI, 0.3 to 7.4; not statistically significant) and in 2.9% of myopic eyes. In myopic eyes, it followed the implantation of ZSAL-4 IOL in 3.9% of eyes (OR, 4.1; 95% CI, 0.5 to 33.6; not statistically significant), and of ZSAL-4 Plus IOL in 1%. Mean time from surgery was 8.5 G 10.6 months). Presentation included aqueous flare (100%), posterior synechiae (82%), blurred vision (82%), redness (36%), pain (27%), IOL precipitates (18%), and angular synechiae (9%). Only 1 patient had recurrences, leading to IOL explantation and cataract surgery. After topical therapy, best spectacle-corrected visual acuity was fully recovered in 9 of 11 eyes. CONCLUSION: Iridocyclitis can occur months or years after the implantation of angle-supported phakic IOLs. No statistically significant risk factors were identified. Functional prognosis is generally good. J Cataract Refract Surg 2006; 32:1007–1010 Q 2006 ASCRS and ESCRS
Angle-supported phakic intraocular lenses (pIOLs) are an effective option for the correction of high ametropias.1–3 After their implantation, iridocyclitis was observed in as many as 4.5% of eyes in an earlier series,1,2,4 but the incidence and prognosis of this complication has received little attention in the literature since the introduction of new IOL models. In the present study, a series of eyes implanted with an angle-supported was retrospectively evaluated to assess the
Accepted for publication September 12, 2005. From the Ophthalmic Surgery Unit, Casa di Cura Rugani, Siena, Italy. The author has no financial or proprietary interest in any material or method mentioned. Reprint requests to Antonio Leccisotti, MD, PhD, Piazza V Bersaglieri 2, 53100 Siena, Italy. E-mail: [email protected]. Q 2006 ASCRS and ESCRS Published by Elsevier Inc.
incidence, features, and prognosis of clinically significant iridocyclitis and to identify possible risk factors. PATIENTS AND METHODS The charts of all patients who had angle-supported IOL implantation to correct myopia or hyperopia by 1 surgeon (A.L.) between January 2001 and January 2005 were evaluated. Inclusion criteria were age between 21 and 48 years, subjective contact lens intolerance, best spectacle-corrected visual acuity (BSCVA) of 0.2 or better, anterior chamber depth greater than 3.0 mm including corneal thickness (by ultrasound biometry), endothelial cell density greater than to 2400 cell/mm2, and horizontals corneal diameter (‘‘white-to-white,’’ measured by computed a videokeratographer [Keratograph, Oculus]) between 11.4 mm and 12.6 mm. Primary corneal refractive procedures had been ruled out because of a high refractive error and/or reduced corneal thickness, measured by ultrasound pachymetry. Preoperative exclusion criteria were crystalline lens opacities, glaucoma or ocular hypertension, diabetic retinopathy, and ocular inflammatory disease. Postoperative exclusion criteria were ocular inflammation due to an undersized IOL, moving in the anterior chamber. Corneal endothelium was evaluated by 0886-3350/06/$-see front matter doi:10.1016/j.jcrs.2006.02.030
1007
IRIDOCYCLITIS WITH ANGLE-SUPPORTED PHAKIC IOLS
a noncontact Robo Pachy specular microscope (Konan) for cell density (cells/mm2). The minimum follow-up was 6 months. Slitlamp microscopy, applanation tonometry, and dilated fundoscopy were also performed. An informed consent was provided by all patients. Two hundred twelve patients (356 consecutive eyes) were ultimately included in the study. Mean age was 34.6 years G 7.2 (SD), (range 21 to 48 years). Eighty-one of 212 patients (38%) were men. In myopic eyes, the ZSAL-4 (205 eyes of 125 patients) and the ZSAL-4 Plus (106 eyes of 63 patients) planoconcave, poly(methyl methacrylate) (PMMA) single-piece IOLs were used. These IOLs (Morcher GmbH) are manufactured in 3 overall diameters of 12.5, 13.0, and 13.5 mm, in powers from ÿ5 to ÿ24 diopters (D), and with a total optical zone of 5.5 mm (ZSAL-4) and 5.8 mm (ZSAL-4 Plus); the haptics are z-shaped and posteriorly angulated at 19 degrees (ZSAL-4) and 23 degrees (ZSAL-4 Plus). The ZSAL-4 Plus IOL is an evolution of the ZSAL-4 model and is characterized by longer and more flexible haptics, aiming at decreasing compression forces against angle structures, hence, at reducing haptics-related complications such as pupil ovalization and iridocyclitis.5 In the 45 hyperopic eyes (24 patients), the Type 54 biconvex single-piece PMMA IOL was implanted. This IOL is released in 3 overall diameters of 12.5, 13.0, and 13.5 mm, in powers from C4 to C20 D, and with a total optical zone of 5.0 mm; the haptics are inversely z-shaped and posteriorly angulated at 14 degrees.6 The IOL power was calculated by the van der Hejde formula.7 The overall IOL diameter was calculated by adding 1.0 mm to the horizontal corneal diameter. My surgical technique has been described.8 Briefly, after peribulbar anesthesia, a sclero-corneal 5.5 mm 3.0 mm tunnel (along the steepest meridian on the superior 180 degrees) is made and then the anterior chamber is filled with an ophthalmic viscosurgical device (OVD). A peripheral iridectomy is performed through a separate superior sideport by the Hoffer9 technique (scissor cut followed by aspiration of pigment layer). The lens is inserted, OVD is irrigated out and the wound is closed by 1 or 2 single 10-0 nylon sutures. Ciprofloxacin 0.3% (Oftacilox) and dexamethasone 0.1% (Visumetazone) eyedrops were used 4 times a day for 10 days, after which diclofenac sodium eyedrops (Voltaren) were started
4 times a day for 2 weeks. The short steroid course was chosen to avoid steroid-related ocular hypertension, observed in 18% of myopic eyes having pIOL implantation.8 Follow-up visits were made at 1, 7, and 14 days; 1, 2, 4, 8, 12, 18, and 24 months; and on patient demand if a problem was suspected. All visits comprised uncorrected visual acuity (UCVA) and BSCVA, undilated slitlamp evaluation, iridectomy evaluation, and tonometry. Dilated slitlamp examination and fundoscopy, gonioscopy, and endothelial microscopy were added at 2, 8, 12, 18, and 24 months. Iridocyclitis was defined as clinically significant when slitlamp examination revealed at least 1 of the following signs: endothelial precipitates, anterior or posterior synechiae, and IOL precipitates. Isolated aqueous flare was considered significant only when presenting more than 15 days after surgery and if associated with at least 1 of the following symptoms: decreased BSCVA, ocular or periocular pain, and injection of the perilimbal blood vessels. In patients with iridocyclitis, general health status was evaluated in all patients by anamnesis, complete blood count, eritrosedimentation rate, serum evaluation of antinuclear antibody, angiotensin converting enzyme, rheumatoid factor, blood culture, human leucocyte antigen (HLA) testing, venereal disease research, purified protein derivative, chest and sacroiliac radiography, and dermatological examination. Statistical analysis was performed by StatView (Abacus Concepts, Inc.). Odds ratios and 95% confidence intervals (CIs) were calculated by CIA software (BMJ). For 95% CI of the difference of the means, statistical significance (P!.05) was identified when the interval did not include the null value. For odds ratios, statistical significance (P!0.05) was identified when both 95% CI limits were superior to 1.0.
RESULTS
Clinically significant iridocyclitis occurred in 11 eyes (3.1%) of 11 patients (Table 1). No bilateral cases were observed. Mean age at IOL implantation was 37.2 G 9.5 years, range 22 to 48 years); the difference with the whole series of operated eyes is not statistically significant (95% CI for the
Table 1. Main features at presentation and prognosis of iridocyclitis associated with angle-supported phakic IOLs (11 eyes of 11 patients).
Patient No.
Age (y) at Surgery
Time After Surgery (Mo)
Presentation*
Sequealae
1 2 3 4 5 6
22 38 28 45 44 48
1 1 4 26 13 3, 6, 10
PSCC, DV PSC, DV PSC, redness, pain PSCCC, IP, DV PSCC, IP, DV, pain PSCCC, DV, redness
7 8 9 10 11
42 48 25 29 40
8 31 2 3 1
PSC PSCCCC, DV DV, redness, pain ASC, DV PSCC, DV, redness
PSC None None PSCCC, DV (ÿ0.2) PSC, DV (ÿ0.1) PSCCC, cataract, DV (restored after cataract surgery) None PSCC None None PSC
AS Z angular synechiae; DV Z decreased vision; IP Z intraocular lens precipitates; PS Z posterior synechiae (C Z less than 90 degrees; CC Z 90 degrees to 180 degrees; CCC Z 181 degrees to 360 degrees) *Aqueous flare was observed in all cases.
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difference between means ÿ1.8 to 7.0 years). Seven of 11 patients (64%) were male. Iridocyclitis was observed in 2 of 45 hyperopic eyes (4.4%) and 9 of 311 (2.9%) myopic eyes after the implantation of 2 of 45 Type 45 IOLs (4.4%), 8 of 205 ZSAL-4 IOLs (3.9%), and 1 of 103 ZSAL-4 Plus IOL (1%). The involved eye was the first implanted in 5 cases, the second implanted in 2 cases, and the only 1 implanted in 4 cases. Odds ratios for possible risk factors (male sex, hyperopia, first implanted eye, IOL model) were not statistically significant. Mean time from surgery was 8.5 G 10.6 months, (range 1 to 31 months; 95% CI, 1.3 to 15.6 months). In no patient was general risk factors such as a present or past rheumatological, dermatological, or infectious disease or an HLA-B27, HLA-A29, or HLA-B51 genotype were identified. Presenting symptoms were blurred vision in 9 eyes (82%), redness in 4 eyes (36%), and subtle pain in 3 eyes (27%). Signs were represented by cells and aqueous flare in 11 eyes (100%), posterior synechiae in 9 eyes (82%), small IOL precipitates in 2 cases (18%), 1 o’clock angular synechia (1.0 mm from an IOL footplate) in 1 case (9%) (Figures 1 and 2). No endothelial precipitates were observed. Intraocular lens position was normal, and no pupil ovalization was noted. At gonioscopy, no footplate appeared to erode into the uveal tissue. Only 1 patient had recurrences (2 episodes), leading to anterior and posterior subcapsular cataract, thus requiring IOL explantation, phacoemulsification, and in-the-bag IOL implantation. Post-phacoemulsification course was uneventful, and no further recurrences were observed. In all patients, resolution of active inflammation was observed after topical treatment (atropine 1% eyedrops
twice a day and dexamethasone 0.1% eyedrops every second hour when awake, tapered after improvement). Steroid-induced ocular hypertension (36 mm Hg) was recorded (patient 8) in a highly myopic eye (ÿ23 D); steroid suspension after healing was followed by recovery of normal intraocular pressure. After healing, preinflammatory BSCVA was fully recovered in 9 of 11 eyes, including the patient having phacoemulsification; in the 2 remaining eyes, BSCVA was reduced from 0.7 to 0.5 and from 0.8 to 0.7, respectively, because of pigment deposits on the anterior capsule. Permanent sequelae consisted of posterior synechiae in 6 eyes (1 in the patient having cataract surgery). No other long-term modifications were observed. In the entire series of operated eyes, mean corneal endothelial cell density variation was ÿ6.16% at 12 months. In eyes with iridocyclitis, cell density was evaluated 3 months after complete healing: compared with preoperative count, mean variation was ÿ9.7% G 4.2%, (range ÿ2% to ÿ17%). In the patient having IOL explantation with cataract surgery, endothelial cell density measured before phakic IOL implantation had decreased by 16% after phacoemulsification.
Figure 1. Iridocyclitis occurred 31 months after ZSAL-4 IOL implantation. At presentation, posterior synechiae were almost at 360 degrees (patient 8).
Figure 2. Eye in Figure 1 after 1 month of topical steroids and atropine with pharmacological mydriasis. Residual posterior synechiae are seen at the nasal quadrant, and pigment remnants on the crystalline lens.
DISCUSSION
The incidence of iridocyclitis after the implantation of an angle-supported pIOL was 3.1% in the present series. All observed cases were monolateral, more commonly affecting the first or the only implanted eye, and the mean age at surgery in affected patients was 2.7 years older than in the whole series (not statistically significant). The high variability is noteworthy in terms of presenting time after
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surgery, ranging from 1 to 31 months. The minimum follow-up in this series was 6 months, so the study might have underestimated the incidence of this long-term complication. Clinical presentation was in most cases characterized by posterior synechiae. The prognosis is benign, with complete visual recovery in most cases after a single cycle of topical therapy, although permanent visual reduction may result from posterior synechiae and crystalline lens precipitates. Sequelae were more pronounced in older patients. No significant risks factor were identified in our study. However, the main weakness of the present study is represented by the possibility of having missed risk factors due to very limited samples in each subgroup. Odds ratio calculation becomes imprecise when 1 or more terms are small.10 Anterior chamber pIOL-induced iridocyclitis has been observed with angle-supported1,2,6,8,11 and irisfixated IOLs12,13; the incidence ranges from 1% to 7.7%. The prognosis is generally good, and IOL explantation is rarely required.1,6 Excluding the exceedingly rare cases of bacterial endophthalmitis14 and the uncommon case of undersized, movable IOLs,8 its pathogenesis is unclear but most likely related to chronic iris–IOL contact, as observed with pseudophakic anterior and posterior chamber IOLs.15–17 Haptic-angle interaction has been proposed as a possible mechanism, leading to an improvement of haptics in newer models5; however, iris-fixated anterior chamber pIOLs (with no angular support) do induce a similar iridocyclitis in approximately 7% of eyes.12,13 A subclinical iridocyclitis can be detected by a laser flare–cell meter soon after anterior chamber phakic IOL (both models) implantation and even 24 months later.4 This justifies our cases with late presentation. Ultrasound biomicroscopy and optical coherence tomography, although not performed in the present study, can reveal the contact between IOL and uveal tissues,18 as in studies of pseudophakic iridocyclitis15–17 and on pigment dispersion caused by anterior chamber pIOLs.19 This latter syndrome, although not a true uveitis, shares with phakic IOL-induced iridocyclitis some features (pigment, posterior synechiae).20 Iridocyclitis associated with pIOLs and topical steroids may induce cataract, which can be safely removed together with IOL explantation.21 A challenge in biometry is represented by the presence of an anterior chamber IOL; therefore, it is advisable to perform biometry (and file data) before each pIOL implantation. In conclusion, iridocyclitis is not rare after implantation of angle-supported pIOLs, and is usually characterized by a single episode of reduced vision with posterior synechiae, occurring even years after implantation. Topical therapy is generally effective, and IOL explantation is rarely needed. No significant risk factors were identified;
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therefore, all patients receiving these implants should be appropriately counseled and followed indefinitely. REFERENCES 1. Baikoff G, Arne JL, Bokobza Y, et al. Angle-fixated anterior chamber phakic intraocular lens for myopia of ÿ7 to ÿ19 diopters. J Refract Surg 1998; 14:282–293 2. Alio´ JL, de la Hoz F, Pe´rez-Santonja JJ, et al. Phakic anterior chamber lenses for the correction of myopia: a 7-year cumulative analysis of complications in 263 cases. Ophthalmology 1999; 106:458–466 3. Ferreira de Souza R, Forseto A, Nose´ R, et al. Anterior chamber intraocular lens for high myopia: five year results. J Cataract Refract Surg 2001; 27:1248–1253 4. Pe´rez-Santonja JJ, Iradier MT, Benı´tez del Castillo JM, et al. Chronic subclinical inflammation in phakic eyes with intraocular lenses to correct myopia. J Cataract Refract Surg 1996; 22:183–187 5. Pe´rez-Santonja JJ, Alio´ JL, Jime´nez-Alfaro I, Zato MA. Surgical correction of severe myopia with an angle-supported phakic intraocular lens. J Cataract Refract Surg 2000; 26:1288–1302 6. Leccisotti A. Angle-supported phakic intraocular lenses in hyperopia. J Cataract Refract Surg 2005; 31:1598–1602 7. van der Heijde GL. Some optical aspects of implantation of an IOL in a myopic eye. Eur J Implant Refract Surg 1989; 1:245–248 8. Leccisotti A, Fields VS. Clinical results of ZSAL-4 angle-supported phakic intraocular lenses in 190 myopic eyes. J Cataract Refract Surg 2005; 31:318–323 9. Hoffer KJ. Pigment vacuum iridectomy for phakic refractive lens implantation. J Cataract Refract Surg 2001; 27:1166–1168 10. Breslow NE, Day NE. The analysis of case-control studies. Statistical Methods in Cancer Research. Volume 1. Lyon, France, International Agency for Research on Cancer, 1980, 124–246 11. Allemann N, Chamon W, Tanaka HM, et al. Myopic angle-supported intraocular lenses: two-year follow-up. Ophthalmology 2000; 107:1549–1554 12. Alio´ JL, Mulet ME, Shalaby AMM. Artisan phakic iris claw intraocular lens for high primary and secondary hyperopia. J Refract Surg 2002; 18:697–707 13. Saxena R, Landesz M, Noordzij B, Luyten GPM. Three-year follow-up of the Artisan phakic intraocular lens for hypermetropia. Ophthalmology 2003; 110:1391–1395 14. Pe´rez-Santonja JJ, Ruı´z-Moreno JM, de la Hoz F, et al. Endophthalmitis after phakic intraocular lens implantation to correct high myopia. J Cataract Refract Surg 1999; 25:1295–1298 15. Amino K, Yamakawa R. Long-term results of out-of-the-bag intraocular lens implantation. J Cataract Refract Surg 2000; 26:266–270 16. Chen W, Liu Y, Wang N, et al. Comparison of the effects of two types of intraocular lens. Chin Med J 2001; 114:1286–1289 17. Piette S, Canlas OAQ, Tran HV, et al. Ultrasound biomicroscopy in uveitisglaucoma-hyphema syndrome. Am J Ophthalmol 2002; 133:839–841 18. Jime´nez-Alfaro I, Garcı´a-Feijoo´ J, Pe´rez-Santonja JJ, Cuin˜a R. Ultrasound biomicroscopy of ZSAL-4 anterior chamber phakic intraocular lens for high myopia. J Cataract Refract Surg 2001; 27:1567–1573 19. O¨zdal MPC¸, Mansour M, Descheˆnes J. Ultrasound biomicroscopy of pseudophakic eyes with chronic postoperative inflammation. J Cataract Refract Surg 2003; 29:1185–1191 20. Baikoff G, Bourgeon G, Jodai HJ, et al. Pigment dispersion after Artisan phakic intraocular lens: crystalline lens rise as a safety criterion. J Cataract Refract Surg 2005; 31:674–680 21. Alio´ JL, de la Hoz F, Ruiz-Moreno JM, Salem TF. Cataract surgery in highly myopic eyes corrected by phakic anterior chamber angle-supported lenses. J Cataract Refract Surg 2000; 26:1303–1311
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