A randomized paired eye comparison of two techniques for treating moderately high myopia: LASIK and artisan phakic lens

OBJECTIVE: To compare refractive performance and safety of laser in situ keratomileusis (LASIK) and Artisan phakic intraocular lens (PIOL) for moderately high myopia. DESIGN: A prospective, randomized trial with paired eye control. PARTICIPANTS: Twenty-five patients with myopia ranging from -8.00 to -12.00 diopters (D). INTERVENTION: For each patient, one eye received LASIK and the other one was implanted with an Artisan phakic intraocular lens. The treated eye and the surgical technique were randomized. MAIN OUTCOME MEASURES: Primary outcome measure was spherical equivalent refraction. Main secondary outcome measures were the change of two or more lines and safety index (ratio postoperative to preoperative best-corrected visual acuity). RESULTS: One year after surgery, the mean spherical equivalent refraction was -0.74 +/- 0.67 D for LASIK-treated eyes and -0.95 +/- 0.45 D for Artisan-treated eyes, and the majority of LASIK-treated eyes (64%) and Artisan-treated eyes (60%) were within +/-1.00 D of the intended result. At 1 month, the mean spherical equivalent refraction was -0.28 +/- 0.71 D for LASIK and -1.07 +/- 0.59 D for Artisan (P < 0.01). The changes of two or more lines were in favor of Artisan (P < 0.05). The safety index was significantly better for Artisan (1.12 +/- 0.21) than for LASIK (0.99 +/- 0.17) at 1 year (P < 0.02). CONCLUSIONS: In cases of moderately high myopia, LASIK and Artisan phakic intraocular lenses seemed to produce a similar predictability. The best-corrected visual acuity and subjective evaluation of quality of vision were better for Artisan.     

有晶状体眼后房型人工晶状体植入术矫正高度近视

探讨有晶状体眼后房型人工晶状体（phakic intraocular lens,PIOL）植入术矫正高度近视的有效性和安全性。 方法：本研究中高度近视患者17例33眼,术前屈光度-8.00～-24.00 (平均-15.46±6.26)D,眼轴长度25.33～33.77(平均30.22±2.55)mm。33眼植入后房型人工晶状体也称植入性接触镜（implantable contact lens,ICL& toric implantable collamer lens, TICL）。其中,22眼植入ICL,11眼植入TICL。术后观察视力、屈光度、眼压、人工晶状体位置等。 结果：所有病例均成功植入后房型人工晶状体。术后1wk,所有手术眼达到或超过术前最佳矫正视力,屈光度和眼压稳定。 结论：有晶状体眼后房型人工晶状体植入术治疗高度近视安全有效,适用屈光度范围广,术后屈光度稳定,视觉质量提高     

Myopic implant of the posterior chamber using a flexible Collamer lens

BACKGROUND: The purpose of this study was to report results, effectiveness and safety of implanting a negative collagen/HEMA copolymer posterior chamber phakic intraocular lens in moderate to highly myopic eyes. MATERIAL AND METHODS: 23 eyes from 12 patients with a mean preoperative spherical equivalent refraction of - 10.94 +/- 5.97 D underwent a refractive procedure with the Staar ICL trade mark posterior chamber phakic intraocular lens. The average follow-up was 12.9 +/- 7.4 months (range 4 - 24 months). Preoperative and postoperative uncorrected and best corrected visual acuity, subjective refraction, intraocular pressure, keratometry, ICL trade mark centration and anterior subcapsular opacities were evaluated. RESULTS: Postoperative uncorrected visual acuity improved in all eyes. The best corrected visual acuity increased from 0.82 +/- 0.39 preoperatively to 1.05 +/- 0.24 postoperatively. The gain in visual acuity was statistically significant (Student t-test, p = 0.0097). The mean postoperative spherical equivalent refraction was - 0.82 +/- 1.42 D (p < 0,0001). The mean postoperative intraocular pressure was 15.65 +/- 2.72 mm Hg. The intraocular contact lens remained well centred in all eyes and no anterior subcapsular opacities were observed. Three patients underwent transcient complication without affecting the visual outcome. CONCLUSION: The use of a posterior chamber phakic intraocular lens in myopic eyes is a safe procedure to correct moderate to high myopia. Long-term results are still unknown.     

Phakic posterior chamber lens implantation in children with high myopia

PURPOSE: To evaluate the anatomical and functional results after implantation of a phakic posterior chamber lens (implantable contact lens [ICL]) to correct high myopia with amblyopia in pediatric patients in whom conventional treatments had failed. SETTING: Department of Ophthalmology, Purpan Hospital, University of Toulouse, France. METHODS: An ICL was implanted in 5 eyes with amblyopic high myopia in 4 children aged 3 to 16 years. Mean preoperative spherical equivalent refraction was -12.8 diopters (D) (range -8.0 to -18.0 D) and best spectacle-corrected visual acuity (BSCVA) was counting fingers to 20/200. Mean follow-up was 11.8 months (range 4 to 21 months). RESULTS: Postoperatively, the ICLs appeared to be well tolerated, with no inflammatory reactions, stable intraocular pressure, and good positioning in all eyes. Predictability was +0.5 D (range -0.5 to +2.0 D) and BSCVA improved, with a gain of 3 or more Snellen lines with recovery of binocular vision in 2 cases and orthotropia in 3 patients. All parents reported an improvement in their children's quality of life. CONCLUSION: This preliminary study indicates that ICL implantation is a safe surgical procedure to correct amblyopia resulting from high myopia in children when conventional amblyopia treatments have failed. Longer follow-up of more patients is needed.     

Laser in situ keratomileusis and photorefractive keratectomy for residual refractive error after phakic intraocular lens implantation

PURPOSE: To determine the visual and refractive outcome of photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK) in eyes with prior posterior chamber phakic intraocular lens implantation for high myopia. METHODS: We studied a series of 37 consecutive eyes of 31 patients who underwent LASIK or PRK for residual refractive error following collamer posterior chamber intraocular lens (IOL) (Staar Surgical Implantable Contact Lens) implantation into a phakic eye. Twenty-eight eyes had LASIK and nine eyes had PRK. Mean follow-up was 8.1 +/- 4.7 months after laser ablation (range, 3 to 18 mo). RESULTS: The preoperative mean spherical equivalent refraction prior to phakic posterior chamber IOL implantation was -17.74 +/- 4.89 D (range, -9.75 to -28.00 D). Following phakic IOL implantation and prior to LASIK or PRK, mean spherical equivalent refraction was -2.56 +/- 2.34 D (range, -0.25 to -8.75 D). One month following LASIK or PRK, mean spherical equivalent refraction was -0.24 +/- 0.52 D (range, -1.50 to +1.50 D), 3 months following LASIK or PRK, mean spherical equivalent refraction was -0.19 +/- 0.50 D (range, -1.50 to +1.00 D). The refraction was within +/-1.00 D of emmetropia in 36 eyes (97.2%) and within +/-0.50 D in 31 eyes (83.7%). Three eyes developed anterior subcapsular opacities several weeks after laser ablation, one eye developed macular hemorrhage 4 weeks after laser ablation, and one eye had corticosteroid induced ocular hypertension. CONCLUSIONS: LASIK or PRK can be used to treat the residual refractive error following posterior chamber phakic IOL implantation.     

Combined posterior chamber phakic intraocular lens and laser in situ keratomileusis: bioptics for extreme myopia.

PURPOSE: To examine the efficacy, predictability, stability, and safety of combined posterior chamber phakic intraocular lens (IOL) implantation and laser in situ keratomileusis (LASIK) in eyes with extreme myopia. METHODS: We analyzed the results of 67 eyes that received a posterior chamber hydrogel-collagen plate phakic IOL (STAAR Collamer Implantable Contact Lens) and also underwent secondary LASIK for the correction of extreme myopia. Mean follow-up was 3 months after the LASIK portion of the procedure (range, 1 day to 6 mo after LASIK). RESULTS: Mean preoperative spherical equivalent refraction was -23.00 +/- 3.60 D (range, -18.75 to -35.00 D), and mean refractive cylinder was 1.50 +/- 1.20 D (range, 0 to 5.00 D). Mean spherical equivalent refraction after IOL implantation and before LASIK was -6.00 +/- 2.80 D (range, -2.00 to -14.38 D) and mean refractive cylinder 1.50 +/- 1.10 D (range, 0 to 5.00 D). Mean postoperative spherical equivalent refraction at last examination after the LASIK portion of the two-part phakic IOL-LASIK procedure was -0.20 +/- 0.90 D (range, +1.75 to -5.13 D), and mean refractive cylinder was 0.50 +/- 0.50 (range, 0 to 2.25 D). Eighty-five percent (57 eyes) were within +/- 1.00 D and 67% (45 eyes) were within +/- 0.50 D of emmetropia at last examination. The refractions remained stable with a statistically insignificant change (P > .05 at each interval) during follow-up. Postoperative uncorrected visual acuity at last examination was 20/20 or better in 3% (2 eyes) and 20/40 or better in 69% (46 eyes). A gain of 2 or more lines of spectacle-corrected visual acuity was seen in 51 eyes (76%) and no eyes lost 2 or more lines of spectacle-corrected visual acuity at last examination. CONCLUSION: Combined posterior chamber phakic IOL implantation with the STAAR Collamer plate lens and LASIK (bioptics) is an effective and reasonably predictable method for correcting myopia from -18 to -35 D. Gains in spectacle-corrected visual acuity were common, and results demonstrated good short-term safety and refractive stability.     

The use of a foldable, iris-fixated, phakic intraocular lens for the correction of myopia

BACKGROUND: The aim of this study was to evaluate the predictability and visual outcome of a foldable silicone iris-fixated phakic intraocular lens (Artiflex, Ophtec) for the correction of moderate to high myopia. PATIENTS AND METHODS: A retrospective cohort study with 34 eyes of 20 patients was undertaken. All patients underwent similar lens implantation with iris enclavation. The follow-up was 6 months. RESULTS: At the final visit, 81% of eyes were within 0.5 D of the target spherical equivalent. Intraocular lenses with -12.0 to -14.5 D power showed a mean overcorrection of +0.81 D. The highest mean overcorrection of +1.45 D was shown by the Artiflex lenses with -14.5 D of power. The postoperative refraction remained stable, but the postoperative uncorrected and best-corrected visual acuity increased over time. 56% of eyes gained 1 or more Snellen lines of best-corrected visual acuity; one eye lost one line. No intraoperative complication was noticed. Two eyes showed prolonged intraocular inflammation. CONCLUSIONS: The implantation of the phakic Artiflex intraocular lens was safe and showed a good predictability and safety for the correction of moderate to high myopia. It is an efficient alternative for laser in-situ keratomileusis, especially in high myopia, leading to a stable refraction one month postoperatively.     

有晶状体眼后房型人工晶状体植入矫正高度近视的临床评价

目的评价有晶状体眼后房型人工晶状体植入矫正高度近视的有效性、安全性及稳定性。方法选取1997年1月至2005年12月在我院就诊高度近视患者113例（216只眼）,平均年龄30岁,均在球周麻醉及表面麻醉下经3．2mm透明角膜切口植入后房型人工晶状体（ICLV2型15例,ICLV4,美国STAAR公司）,随访术前及术后1d、1周及1、3、6、12、24、36个月,随访内容包括裸眼视力、最佳矫正视力、角膜地形图、屈光度数、裂隙灯显微镜检查、眼压、角膜内皮计数等。术前检查等效球面屈光度数（17．78±3．88）D,平均随访18．2个月后观察屈光状态,24．3个月后观察术后并发症。结果所有手术均顺利进行,所有患者裸眼视力均有明显提高,最后一次随访等效球面屈光度数为（-1．00±1．40）D,与预期屈光度数差别±1．00D以内者191只眼（88．4％）,±0．50D以内者165只眼（76．4％）。术前屈光度数在-20．00D以下的有151只眼,与预期屈光度数差别±1．00D以内者145只眼（96．0％）,±0．50D以内者128只眼（84．8％）。随访期间屈光度数差异无统计学意义（P〉0．05）,术后1年最佳矫正视力提高1行及以上168只眼（77．8％）,4只眼（1．85％）下降1行。4只眼（1．85％）发生需手术治疗瞳孔阻滞性青光眼,3只眼（1．39％）发生晶状体前囊下混浊,均行人工晶状体取出,晶状体摘除及人工晶状体植入术,术后最佳矫正视力无下降。结论有晶状体眼后房型人工晶状体植入矫正高度近视具有有效性、安全性及稳定性。（中华眼科杂志,2007,43：1000-1004）     

有晶状体眼后房型人工晶状体植入术对高度近视的疗效

目的：探讨有晶状体眼后房型人工晶状体(implantable contact lens,ICL)植入术对高度近视患者的临床治疗效果。

方法：选取2014-06/2015-06经我院检查确诊为高度近视患者34例68眼,均给予ICL植入术进行治疗。观察治疗后屈光度、视力恢复情况、中央前房深度、角膜内皮细胞计数和眼压情况。

结果：术后1、3、6mo,1、2a的等效球镜屈光度、中央前房深度、裸眼视力、最佳矫正视力恢复情况均优于术前,差异有统计学意义(P<0.05)。术后1、3、6mo,1、2a的角膜内皮细胞计数和眼压情况与术前比较,差异无统计学意义(P>0.05)。术后1、3mo,1、2a的裸眼视力、最佳矫正视力、等效球镜屈光度、中央前房深度比较,差异无统计学意义(P>0.05)。

结论：高度近视患者采用ICL植入术进行治疗,能够改善等效球镜屈光度和中央前房深度,提高裸眼视力,同时对患者眼压和角膜内皮细胞影响较小,效果维持及安全性较好。     

ICL植入术矫正超高度近视的临床效果观察

目的:评估有晶状体眼后房型人工晶状体(ICL)矫正超高度近视的疗效及安全性。方法:对超高度近视患者20例40眼接受普通型ICL或散光型后房型人工晶状体(TICL)治疗,术前屈光度球镜-10.0～-18.0D,柱镜-0.25～-3.00D,等效球镜-15.32D,术后随访12mo,观察指标包括UCVA,BCVA、角膜地形图、主观和客观验光、角膜内皮细胞计数、眼压测量、裂隙灯检查。结果:术后12mo,裸眼视力≥0.8者占80.0%(32眼)。30.0%(12眼)的术眼BCVA较术前提高1行,15.0%(6眼)的术眼BCVA较术前提高2行。术后12mo术眼屈光度在±0.50D者达70.0%(28眼)。术前患者平均眼压为16±2.8mmHg,术后6mo平均眼压为17±3.4mmHg,术前术后相比较差异无显著性(t=0.518,P=0.776),术前患者角膜内皮细胞计数平均为2823±243.6个/mm2,术后6mo平均为2709±273.2个/mm2,术前术后比较无显著性差异(t=0.794,P=0.422)。未发生继发性青光眼、视网膜脱离及并发性白内障。结论:ICL植入术矫正超高度近视具有良好的疗效和安全性,远期效果有待进一步观察。     

Phakic intraocular lens to correct high myopic amblyopia in children

PURPOSE: In a clinical investigation, we evaluated anatomical and functional outcomes of posterior phakic chamber lens (ICL) implantation for correction of high myopia with amblyopia in children. METHODS: Twelve eyes of 11 children, age 3 to 16 years, with high myopic amblyopia were operated with implantation of a Staar Surgical ICL. In these patients, conventional therapy with spectacles or contact lenses was unsuccessful. Mean preoperative spherical equivalent refraction was -12.70 D (range -8.00 to -18.00 D) and best spectacle-corrected visual acuity ranged from count fingers to 20/63. Mean follow-up was 20.5 months (range 3 to 48 mo) Preoperative and postoperative anatomical and functional outcomes were compared. RESULTS: We noted good tolerance of ICLs without inflammatory reactions or secondary capsular opacity, stable intraocular pressure, and good ICL position in all eyes. Predictability was +0.71 D (range -0.75 to +2.00 D). Mean postoperative best spectacle-corrected visual acuity was 20/63. Recovery of binocular vision was achieved in six patients and orthotropic position in seven patients. Quality of life was improved in all patients. CONCLUSION: The Staar Surgical phakic ICL appeared to be an effective method to treat high myopia in children with amblyopia. Good results with high satisfaction were noted.     

Phakic posterior chamber intraocular lens for high myopia

PURPOSE: To evaluate the efficacy, predictability, stability, and safety of the surgical correction of high myopia using a phakic posterior chamber intraocular lens (PPC IOL). SETTING: Centro Oftalmológico de Valencia-CEOVAL, Valencia, Venezuela. METHODS: A retrospective study was performed to analyze 18 eyes of 12 patients who had implantation of a modified PPC IOL, the implantable contact lens (ICL), for the treatment of high myopia. The target postoperative spherical equivalent (SE) refraction was emmetropia. RESULTS: The mean follow-up was 26.6 months +/- 11.3 (SD) (range 12 to 36 months). The mean preoperative SE was -15.27 +/- 3.47 diopters (D) (range -10.0 to -21.25 D) and the mean postoperative SE, -0.62 +/- 0.81 D (range -2.75 to +0.75 D). Eleven eyes (61.1%) had an SE within +/-1.00 D of emmetropia. The best spectacle-corrected visual acuity was maintained or improved in all except 1 eye, which lost more than 2 lines of Snellen visual acuity. Two eyes (11.1%) developed pupillary block the first day after surgery. Four eyes (22.2%) had moderate pigmentary dispersion. Two eyes (11.1%) had lens opacification, 1 with mild peripheral anterior capsule opacification and the other eye with central anterior subcapsular opacification. One eye (5.5%) had a significant decrease in anterior chamber depth after surgery. CONCLUSIONS: Implantation of an ICL was effective for the correction of high myopia. Predictability must be improved and the long-term safety of the ICL determined. The main concerns over potential cataract formation, pigmentary dispersion, and angle-closure glaucoma remain.     

Use of Verisyse/Artisan phakic intraocular lens for the reduction of myopia in a patient with pellucid marginal degeneration

PURPOSE: To describe a patient who underwent implantation of a Verisyse/Artisan iris-fixated phakic intraocular lens (IOL) for correction of high myopia in pellucid marginal degeneration (PMD). METHODS: A patient with PMD was observed during a period of 7 years after the implantation of a Verisyse/Artisan phakic IOL. At each visit, slit-lamp evaluation was performed, and corneal topography, endothelial cell count, manifest refraction, and uncorrected and best-corrected visual acuity were determined. RESULTS: Verisyse/Artisan phakic IOL implantation was performed for the correction of the patient's high myopia in the presence of early-stage PMD. The preoperative refraction of the right eye was -13.0 -3.0 x 90 degrees. The postoperative spherical equivalent (SE) was +0.50 D after 1 year and +0.50 D after 7 years. The preoperative refraction of the left eye was -13.0 -1.25 x 55 degrees. The postoperative SE was -0.38 D after 1 year and -0.13 D after 7 years. Preoperative topographic astigmatism for the right and left eye was 2.94 and 0.81 D, respectively. Seven years later, topographic astigmatism for the right and left eye had changed to 4.45 and 0.71 D, respectively. CONCLUSIONS: This case shows that the implantation of a Verisyse/Artisan phakic IOL may be effective in the treatment of refractive error in PMD. This case discusses the value of a removable (as opposed to a permanent) solution, such as the Verisyse/Artisan phakic IOL device, in the treatment of refractive error in PMD.     

高度近视可植入接触镜植入术的效果观察

目的观察高度近视可植入接触镜（ICL）的安全性和有效性。方法对77例（140眼）高度近视施行Staar Col-lamer单片式ICL植入。并在术前2周行激光周边虹膜切除术（少数病例在术中施行周边虹膜切除术）。平均年龄28岁（20-37岁）,角膜厚度0.463-0.582 mm,平均0.511 mm,屈光度-20.50D--8.50D,平均-15.50D。随诊观察0.5-2.5年,查视力,测眼压,验光。结果术后裸眼远视力全部较术前提高,70眼（50.00%）裸眼视力好于术前最佳矫正视力,60眼（42.86%）裸眼视力等于术前最佳矫正视力,10眼（7.14%）因高度散光（-3.00D）较术前矫正视力低。1眼（0.714%）术后出现前房纤维素样渗出,12眼（8.57%）出现一过性高眼压,用药后均正常,随诊观察0.5-2.5年,视力无回退,眼压,晶状体及角膜内皮情况较术前均无变化。结论 ICL治疗-8.00D--20.00D高度近视效果好,损伤小,恢复快,具有良好的安全性、有效性和可预测性。     

Posterior chamber collamer phakic intraocular lens for myopia and hyperopia.

PURPOSE: To assess the feasibility of correcting refractive errors using a foldable posterior chamber phakic intraocular lens. METHODS: Thirty-four foldable posterior chamber phakic intraocular lenses (STAAR Collamer intraocular lens) were consecutively implanted by the same surgeon (PMP) in 19 myopic eyes and 15 hyperopic eyes. In myopic eyes, mean preoperative spherical equivalent refraction was -16.65 +/-3.37 D (range, -8.12 to -21.25 D). In hyperopic eyes, mean preoperative spherical equivalent refraction was +7.77+/-2.08 D (range, +4.75 to +11.75 D). Mean follow-up was 12 months (range, 6 to 18 mo). Two hyperopic eyes were not included in the data analysis because of removal of the intraocular lens due to pupillary block. RESULTS: Myopic eyes (n=19)-Mean spherical equivalent postoperative refraction was -1.51+/-1.37 D (range, -5.50 to+0.38 D). Postoperative refraction was within +/-0.50 D in 4 eyes (21.05%) and within +/-1.00 D in 8 eyes (42.10%). Uncorrected visual acuity was 20/40 or better in 12 eyes (63.15%) and 20/25 or better in 3 eyes (15.78%). No eye had an uncorrected visual acuity of 20/20 or better. Spectacle-corrected visual acuity was 20/40 or better in all eyes, 20/25 or better in 12 eyes (63.15%), and 20/20 or better in 1 eye (5.26%). Spectacle-corrected visual acuity was unchanged in 10 eyes (52.63%) and improved in 9 eyes (47.36%). A retinal detachment developed in 1 eye (5.26%). Hyperopic eyes (n=15)-Mean spherical equivalent postoperative refraction was +0.02+/-0.64 D (range, -1.00 to +1.50 D). Postoperative refraction was within +/-0.50 D in 9 eyes (69.25%) and +/-1.00 D in 12 eyes (92.30%). Uncorrected visual acuity was 20/40 or better in 6 eyes (46.15%) and 20/25 or better in 3 eyes (20.25%). No eye had an uncorrected visual acuity of 20/20 or better. Spectacle-corrected visual acuity was 20/40 or better in 7 eyes (53.84%), 20/25 or better in 6 eyes (46.15%), and 20/20 or better in 2 eyes (15.38%). Spectacle-corrected visual acuity was unchanged in 10 eyes (76.92%), significantly improved in 2 eyes (15.38%), and worse in 1 eye (7.69%). Two of 15 eyes (13.33%) developed a severe pupillary block necessitating removal of the implants. One eye (7.69%) developed an anterior subcapsular cataract. CONCLUSIONS: Refractive predictability appears better for hyeropia than for myopia using the STAAR Collamer foldable posterior chamber phakic intraocular lens. In hyperopic eyes, development of pupillary block may occur.     

后房型有晶状体眼人工晶状体矫治高度近视眼的3年随访报告

目的 观察后房型有晶状体眼人工晶状体(PCPIOL)矫治高度近视眼的长期安全性和有效性.方法 高度近视眼患者41例(66只眼),等效球镜度数(SE)(-15.12±3.93)D,植入PCPIOL.术后随访3年,观察手术前后的视力、屈光状态、眼压、角膜、前房、瞳孔、PCPIOL和晶状体、眼底情况,并进行比较.结果 与术前比较,术后3、6个月、1、2、3年的裸眼视力(UCVA)、最佳矫正视力(BCVA)和SE显著改善.术后3年时,UCVA≥0.5有86%,≥0.8有43%;BCVA未见下降,11%比术前提高1行,68%比术前提高≥2行;96%眼的实际屈光度数稳定在预期的±1.00D,57%稳定在预期的±0.50D.术后1、2、3年的角膜内皮细胞累积丢失率分别为9.26%、12.84%、18.54%.除了1只眼黄斑出血外,未见其他并发症发生.结论 PCPIOL矫治高度近视术后3年内安全、有效.     

Adjustable refractive surgery: 6-mm Artisan lens plus laser in situ keratomileusis for the correction of high myopia

PURPOSE: To evaluate efficacy, predictability, stability and safety of adjustable refractive surgery (ARS) by combining a phakic intraocular lens (IOL) (Artisan lens 6-mm optical zone [OZ]) and laser in situ keratomileusis (LASIK) (6.5 mm OZ) for the correction of myopia greater than -15.00 diopters (D). DESIGN: Noncomparative interventional case series. PARTICIPANTS: Twenty-six eyes of 18 patients with a preoperative spherical equivalent between -16.00 and -23.00 D. METHODS: First surgery: An 8.5/9.5-mm flap was created and a 6-mm optic iris claw phakic IOL of -15.00 D was inserted in the anterior chamber through a posterior corneal incision. The second surgery was performed once refraction and topography were stable, between 3 and 5 months later. Second surgery: LASIK enhancement (6.5-9.2 OZ); the flap was relifted, and the residual refractive error was corrected. MAIN OUTCOME MEASURES: The main parameters in this study were uncorrected visual acuity, best-corrected visual acuity (BCVA), refraction, contrast sensitivity, endothelial cell count (ECC), and subjective response. RESULTS: Twenty-eight months after both surgeries, 80.70% of the eyes were within 0.50 D of emmetropia and 100% within 1.0 D. Twenty-six percent of the eyes gained 3 or more lines from their preoperative BCVA, and 42% gained 2 or more lines. There was no visual loss in any eye from 6 weeks to 24 months after LASIK enhancement (second surgery) and refraction, and visual acuities remained stable. Two subjects (11%) had some subjective disturbances at night. There was a 0.61% mean loss of ECC during the first 12 months and a 0.60% loss during the next 16 months. No serious complications were observed. CONCLUSIONS: ARS with the combination of a 6-mm optic, 15 D Artisan lens, and LASIK appears to be a safe and highly predictable method for the correction of myopia greater than -15.00 D. It is the best approach with the technology currently available.     

Comparison of implantable collamer lens (ICL) and laser-assisted in situ keratomileusis (LASIK) for low myopia

PURPOSE: To compare the results of laser-assisted in situ keratomileusis (LASIK) and implantable collamer lenses (ICL) in the correction of myopia -4 to -7.88 D. METHODS: A total of 1678 LASIK eyes from the Davis Duehr Eye Center, Madison, WI, and 144 ICL eyes from the 14-site US FDA Clinical Trial for ICL for Myopia were compared. Both series were concurrently operated on with 4 to 7.88 D of preoperative spherical equivalent of the manifest refraction and were examined at 1 day, 1 week, 1 month, and 6 months postoperatively. The mean baseline myopia was slightly higher in the ICL group (ICL: -6.4 +/- 1.1 D; LASIK: -5.6 +/- 1.1 D). Best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), and refractions were collected prospectively in both series. RESULTS: BSCVA loss of at least 2 lines was significantly higher in the LASIK series in the early healing period (1 week: 6% vs. 0.7%; P = 0.008), whereas a BSCVA gain of at least 2 lines was statistically better with the ICL at 1 (5% vs. 0.9%, P = 0.001) and 6 months (4% vs. 0.8%, P = 0.013). Proportion of cases seeing 20/15 or better uncorrected (21.6% vs. 7.8%, P < 0.001) and 20/20 or better (67% vs. 57%, P = 0.027) at 6 months postoperatively was better in the ICL group. The ICL was statistically more predictable (attempted vs. achieved) at 6 months; +/-0.50 D (79% ICL vs. 70% LASIK, P = 0.034) and +/-1.0 D (97% ICL vs. 88% LASIK, P < 0.001). Stability was achieved (95% < or = 1.0 D) at the 1-week to 1-month interval for both groups (95% LASIK; 98% ICL). The stability of refraction (< or =0.5 D change) was significantly better in the ICL group than the LASIK group through 6 months. No serious complications occurred in either series. CONCLUSIONS: The ICL was safer and more effective than LASIK and seems to be a viable alternative to corneal refractive excimer surgery in the treatment of low myopia.     

Exchange of a posterior chamber phakic intraocular lens in a highly myopic eye

A 38-year-old woman had posterior chamber phakic intraocular lens (IOL) implantation as a secondary refractive procedure to correct residual refraction (20/50 with -16.50 -1.50 x 80) in May 1998, 3 years after intrastromal corneal ring segment surgery for high myopia (-30.00 diopters). Ultrasound biomicroscopy revealed an oversized lens, leading to malpositioning. Moreover, the patient remained undercorrected (20/40 with -5.25 -0.75 x 120). Ten months later, the phakic IOL was uneventfully exchanged for a shorter one with the correct dioptric power. It was well placed in the posterior chamber. The patient's visual acuity was 20/30 with -2.25 -0.75 x 145, very close to the refraction in the fellow aphakic eye (20/30 with -2.50 -0.75 x 75). Patient satisfaction with the final visual outcome was high. Accurate ciliary sulcus measurement is critical for proper phakic IOL sizing.     

Implantable contact lens for high myopia.

PURPOSE: To evaluate the efficacy, safety, and biocompatibility of a collagen polymer implantable contact lens (ICL) (Staar Collamer) as a posterior chamber phakic intraocular lens (IOL) to correct high myopia. SETTING: Departments of Ophthalmology, Helsinki University Central Hospital, Helsinki, and Tampere University Hospital, Tampere, Finland. METHODS: A Staar Collamer posterior chamber phakic IOL was implanted in 38 eyes of 22 patients with a mean age of 39 years (range 24 to 54 years). The mean preoperative myopia was -15.10 diopters (D) (range -7.75 to -29.00 D). Surgical implantation was performed through a 3.0 mm clear corneal sutureless incision using paraocular anesthesia. The patients were followed clinically up to 3 years. The mean follow-up was 13.6 months (range 6 to 24 months) for refractive data and 22.3 months (range 6 to 35 months) for complications. The possible inflammatory response to the ICL was measured using a laser flare meter in 12 eyes. RESULTS: Postoperatively, all eyes had a significant increase in uncorrected visual acuity, allowing all but 3 patients (5 eyes) to manage most activities without spectacles. The mean spherical equivalent refraction at the last examination was -2.00 D +/- 2.48 (SD) (range +0.13 to -13.00 D), within +/-1.00 D of the targeted refraction in 31 eyes (81.6%) and within +/-0.50 D in 27 eyes (71.1%). In eyes in which the preoperative myopia was less than -18.00 D (n = 28), the achieved refraction was within +/-1.00 D of the intended refraction in 27 eyes (96.4%) and within +/-0.50 D in 24 eyes (85.7%). The refraction remained stable with a statistically insignificant change (P >.05) at each interval during the follow-up. The best corrected visual acuity (BCVA) improved by 1 or more lines in 23 of 32 eyes (71.9%) at 1 year. Two eyes (6.3%) lost 1 line of BCVA. Laser flare photometry showed normal aqueous flare values (11.71 +/- 6.61 photon counts/ms) in the 12 eyes measured at least 6 months after ICL implantation. Pupillary block glaucoma requiring surgical intervention occurred in 3 patients (7.9%). One patient (2.6%) developed cataract 1.5 years after ICL implantation; both ICLs were removed, and the refractive errors were corrected by lensectomy and implantation of low-power posterior chamber IOLs. One patient (2.6%) showed progression of dry macular degeneration at 17 months. CONCLUSION: At 1 year, ICL implantation had good visual and refractive results with excellent biocompatibility. Long-term follow-up is required to confirm that significant complications do not occur in most patients over time.