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.     

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.     

Refractive lens exchange versus iris-claw Artisan phakic intraocular lens for hyperopia

PURPOSE: To study a paired-match comparison between refractive lens exchange with pseudophakic IOL implant (RLE) and Artisan phakic IOL for high hyperopia. METHODS: Nineteen eyes (12 patients, 20 to 41 years old) with an Artisan phakic IOL (Model 203: 1.00-D increment) for hyperopia from +2.75 to +9.25 D were matched to 19 eyes (15 patients, 26 to 46 yr) with hyperopia from +2.75 to +7.50 D, who had refractive lens exchange (pseudophakic IOL implantation; lenses: 0.50-D increment). Average paired-match difference was 1.13 D and 7.7 years of age. RESULTS: At 1 month after surgery, 84% of refractive lens exchange/pseudophakic IOL eyes and 94% of Artisan phakic IOL eyes had a spherical equivalent refraction within +/- 1.00 D of emmetropia; 58% and 68% of eyes, respectively, were within +/- 0.50 D (P = .97). No eye lost lines of best spectacle-corrected visual acuity (BSCVA) and no significant changes in BSCVA were found in any eye at 1 month after surgery (P = .17). The percentage of eyes with uncorrected visual acuity (UCVA) of 20/40 or better improved from 79% to 89% of eyes at 1 to 2 months after phakic IOL; it remained at 89% to 82% of eyes from 1 to 2 months after refractive lens exchange/ pseudophakic IOL. The coefficient of correlation showed statistically better accuracy (intended vs. achieved refraction; P = .035) for the Artisan phakic IOL (R = 0.83) than for refractive lens exchange/ pseudophakic IOL (R = 0.50). CONCLUSIONS: Spherical equivalent refraction outcome and BSCVA after surgery were similar for both procedures. The Artisan phakic IOL in carefully selected patients provided a better overall outcome for young patients with high hyperopia whose accommodation was preserved, as compared to refractive lens exchange.     

Artisan iris-claw phakic intraocular lens followed by laser in situ keratomileusis for high hyperopia

PURPOSE: To evaluate safety, efficacy, predictability, stability, complications, and patient satisfaction after Artisan phakic intraocular lens (IOL) implantation followed by laser in situ keratomileusis (LASIK) for the correction of high hyperopia. SETTING: Instituto Oftalmólogico de Alicante, Alicante, Spain. METHODS: This prospective trial included 39 eyes with a mean preoperative spherical equivalent (SE) of 7.39 diopters (D) +/- 1.30 (SD) and a cylinder between 0 and -4.25 D. The Artisan iris-fixated phakic IOL (Ophtec) for hyperopia was implanted, and LASIK was performed 6 to 8 months later. The best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), refraction, endothelial cell loss (ECL), endothelium morphologic analysis, and patient satisfaction were recorded. The minimum follow-up was 12 months. RESULTS: At 1 year, 37 eyes (94.9%) were within +/-1.00 D of emmetropia and 31 eyes (79.5%) were within +/-0.50 D. Thirty-five eyes (89.7%) achieved a UCVA of 0.5 or better. There was a statistically significant decrease in BCVA after phakic IOL implantation, but this effect was corrected after LASIK. Nine eyes (23.1%) lost 1 line of BCVA; 7 eyes (17.9%) gained at least 1 line. One eye (2.6%) showed a change in SE greater than 1.0 D over the follow-up period. The mean ECL was 10.9%, but morphologic analysis suggested no additional damage caused by LASIK over that produced by phakic IOL surgery. Overall patient satisfaction was high. CONCLUSIONS: The combination of Artisan phakic IOL implantation and LASIK safely, predictably, and effectively reduced high hyperopia. A loss of 1 line of BCVA should be expected in about one third of eyes implanted with this IOL. Halos and glare at night remain a potential problem.     

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.     

A retrospective analysis of the first Indian experience on Artisan phakic intraocular lens

PURPOSE: To evaluate the efficacy, safety, predictability and stability of implanting a polymethylmethacrylate phakic intraocular lens (PIOL) in high myopia. MATERIALS AND METHODS: A retrospective analysis of the data of patients who underwent Artisan phakic IOL implantation between 2002 and 2003 with a follow-up of at least 24 months. RESULTS: An Artisan myopia lens was implanted in 60 eyes of 36 patients with preoperative myopia ranging from -5.0 to -24.0 D. Mean patient age was 22.6 years. Mean spherical equivalent of manifest refraction stabilized by the first postoperative week. At three months follow-up, 54 eyes (90%) had a postoperative refraction within +/- 1D emmetropia and 45 eyes (75%) had uncorrected visual acuity of 20/40 or better. Seven eyes (11.6%) had loss of one Snellen line and none had loss of two Snellen lines or more at three months. The mean endothelial cell loss was 3.8% at three months, 5.2% at six months, 5.25% at 12 months and 6.38% at two years, which was not significant. Postoperative complications included anterior chamber reaction in two eyes (3.3%), rise in intraocular pressure in six eyes (10%) and dislocation of PIOL in two eyes (3.3%). CONCLUSION: Implantation of Artisan myopia lens to correct high myopia resulted in a stable and fairly predictable refractive outcome with few complications. Significant endothelial damage was not detected in two years of follow-up.     

高度近视Zyoptix-LASIK和Artisan有晶状体眼人工晶状体植入术对视觉质量的影响

目的探讨高度近视Zyoptix-LASIK和有晶状体眼Artisan人工晶状体（IOL）植入术后高阶像差和对比敏感度的差异。方法按照术眼中央角膜厚度是否能够满足准分子激光角膜原位磨镶术（LASIK）的条件,将术眼分为LASIK组和ArtisanIOL组。LASIK组15例30眼接受波前像差引导的个体化LASIK,平均年龄27.6岁,屈光度-7.0～-12.0D平均等效球镜（-9.16±1.15）D;ArtisanIOL组17例30眼接受虹膜固定性有晶状体眼ArtisanIOL植入术,平均年龄29.1岁,屈光度-8.0～-14.0D平均等效球镜（-11.51±1.62）D。对比2组术后视力、最佳矫正视力、瞳孔大小、屈光状态、高阶像差、明光、暗光、暗光眩光条件下的对比敏感度等指标。高阶像差值以均方根（RMS）表示,测量总高阶像差（RMSh）、3阶X轴彗差（RMS3x）、3阶Y轴彗差（RMS3y）、4阶球差（RMS4s）及4阶像差（RMS4g）。结果术前2组间年龄和高阶像差的差异均无统计学意义（P〉0.05）。术后ArtisanIOL组的高阶像差低于LASIK组,其中2组间RMSh、RMS3x和RMS4g的差异均有统计学意义（P〈0.05）。术后2组高阶像差与术前相比均增高,但ArtisanIOL组手术前后RMS3x的差异无统计学意义（P=0.793）。ArtisanIOL组在明光、暗光、暗光眩光条件下各空间频率的对比敏感度均高于LASIK组,暗光条件下3、6、12cpd空间频率间的差异有统计学意义（P〈0.05）。结论与个体化LASIK相比,高度近视有晶状体眼植入ArtisanIOL后高阶像差的增加较少,且其暗光下中高空间频率对比敏感度优于LASIK。     

Comparison of iris-fixed Artisan lens implantation with excimer laser in situ keratomileusis in correcting myopia between -9.00 and -19.50 diopters: a randomized study

OBJECTIVE: To compare Artisan lens implantation with laser in situ keratomileusis (LASIK) for the correction of myopia between -9.00 and -19.50 diopters. DESIGN: Prospective randomized clinical trial. PARTICIPANTS: Ninety eyes of 61 consecutive patients were enrolled in the study. INTERVENTION: Forty-five eyes (50%) received Artisan lens, and 45 eyes (50%) received LASIK; the procedure assigned to each eye was randomized. Eighteen patients (29.5%) received Artisan lens in one eye and LASIK in the other. MAIN OUTCOME MEASURES: Slit-lamp microscopy, manifest refraction, uncorrected and spectacle-corrected visual acuity, contrast sensitivity, and specular microscopy were performed before surgery, and 1, 3, 6, and 12 months after surgery. Patient satisfaction and preference were assessed by a subjective questionnaire. RESULTS: At 1 year, 43 eyes (95.6%) from the Artisan group and 41 eyes (91.1%) from the LASIK group were examined, the mean spherical equivalent refraction was -0.64 +/- 0.8 diopter in the Artisan eyes and -0.87 +/- 0.8 in the LASIK eyes. The uncorrected visual acuity was 20/20 or better in 9 Artisan eyes (20.9%) and 5 LASIK eyes (12.2%) and 20/40 or better in 38 Artisan eyes (88.4%) and 24 LASIK eyes (58.5%); no Artisan eyes and 5 LASIK eyes (12.2%) lost 2 or more Snellen lines of spectacle-corrected visual acuity. One Artisan eye (2.3%) and six LASIK eyes (14.6%) reported severe night glare; the Artisan lens was exchanged with a larger optic diameter lens. Mean endothelial cell loss at 1 year was 0.7 +/- 1.1 cells/mm(2) in the Artisan eyes and 0.3 +/- 0.9 cells/mm(2) in the LASIK eyes. Contrast sensitivity curve decreased by 2 or more lines in two Artisan (4.7%) and six LASIK eyes (14.6%). Of the 18 patients who received both surgeries, one in each eye, 13 patients (72.2%) preferred the Artisan procedure because of the better quality of vision. CONCLUSIONS: In this study, Artisan lens implantation and LASIK were found to be similarly effective, stable, and reasonably safe for the correction of myopia between -9.00 and -19.50 diopters. Better uncorrected and spectacle-corrected visual acuity and contrast sensitivity, a lower enhancement rate, and exchangeability are the main advantages of Artisan lens implantation. Thirteen (72.2%) of the 18 patients who received the Artisan lens in one eye and LASIK in the other preferred the Artisan lens to the LASIK, mainly because of the better quality of vision.     

Three-year follow-up of the Artisan phakic intraocular lens for hypermetropia

PURPOSE: We report the postoperative results of the Artisan Hyperopia phakic intraocular lens (IOL; model 203W; Ophtec, Groningen, The Netherlands). DESIGN: Prospective, nonrandomized trial. PARTICIPANTS: Twenty-six eyes of 13 self-selected patients with refractive error ranging from +3.00 to +11.00 diopters (D). INTERVENTION: Patients with hypermetropia were implanted with the Artisan Hyperopia phakic IOL. Mean follow-up was 22.4 months (range, 3-36 months). MAIN OUTCOME MEASURES: Predictability, stability, efficacy, loss of best spectacle-corrected visual acuity, and complications. RESULTS: At six months, 90.9% (20 of 22 eyes) were +/-1.00 D of intended correction and 81.8% (18 eyes) were +/-1.00 D of emmetropia. The mean spherical equivalent was stable within 0.25 D during the entire 3-year follow-up period. Twenty-four eyes (92.3%) had a postoperative best spectacle-corrected visual acuity of 0.50 or better at all of their individual follow-up examinations. No patient lost 2 or more lines after the procedure. There was a significant negative correlation between anterior chamber depth and endothelial cell loss. Two patients experienced posterior synechiae with pigment deposits in both eyes. One of these patients had convex irides and underwent implant removal within 2 years with a consequent clear lens extraction and posterior chamber lens implantation. CONCLUSIONS: Implantation of the Artisan Hyperopic lens leads to accurate and stable refractive results with no significant loss of vision. More attention should be paid to convex irides and shallow anterior chambers during the preoperative screening to avoid unnecessary complications.     

Artisan Phakic Intraocular Lens for Correcting High Myopia

Objectives: To evaluate the safety indexes and efficacy of Artisan phakic intraocular lens (IOL) for the correction of high myopia. Methods: Retrospective interventional case series reports. Thirty-one eyes (22 patients) with myopia from −5.25 to −19.00 diopters underwent implantation of an Artisan phakic IOL. Follow-up examinations were performed at 1 day, 1 week, 1 month, and 3 months. The following parameters were recorded: manifest refraction, slit-lamp examination, applanation tonometry, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), complications or adverse reactions. The primary variable was the refractive outcome at 3 months. Secondary variables were change in BSCVA, and efficacy and safety indexes. Results: At 3 months, mean spherical equivalent was −0.50 ± 0.36 diopters (range, −1.25 – plano). In 29 eyes (93.5%) UCVA was 6/12 or better; the other three eyes had UCVA of 6/15. The difference between preoperative and 1 week postoperative BSCVA was not statistically significant (p=0.25). Comparison of BSCVA at 1 week and at 1 month was statistically significant (p=0.05); this difference was even more significant at 3 months (p=0.01). The BSCVA remained the same or improved for all the eyes. BSCVA for 20 eyes (64.5%) had improved one or more lines in visual acuity. Mean endothelial cell loss at 3 months was 3.96%. Conclusion: The Artisan lens is a safe, predictable, and efficacious method to correct high myopia. Postoperative gain in BSCVA was achieved for the majority of eyes. Future study to assess safety indexes and risk of complications is required with long-term follow-up.     

Photorefractive keratectomy or laser in situ keratomileusis for residual refractive error after phakic intraocular lens implantation

PURPOSE: To evaluate the results of combining phakic posterior chamber intraocular lens (IOL) implantation and excimer corneal surgery to treat high myopia or myopia with astigmatism. SETTING: Service d'Ophtalmologie, H?pital Purpan, University of Toulouse, Toulouse, France. METHODS: Thirty-two eyes of 28 patients with extreme myopia or myopia combined with astigmatism were treated by implantation of a phakic posterior chamber IOL. Residual refractive errors were treated no earlier than 6 weeks after IOL implantation by photorefractive keratectomy (PRK) in eyes with low refractive errors or by laser in situ keratomileusis (LASIK) in eyes with higher residual refractive errors. RESULTS: The mean preoperative spherical equivalent (SE) refraction was -18.7 diopters (D). The refractive astigmatism ranged from 0 to 3.5 D. After excimer laser treatment, the SE refraction ranged from -0.5 to -2.5 D and the refractive astigmatism, from 0 to 1.5 D in the PRK group. In the LASIK group, spherical ametropia ranged from -1.5 to +1.5 D and astigmatism, from 0 to 1.0 D. After excimer laser treatment, the uncorrected visual acuity improved in all eyes but a loss of 1 line of the corrected vision after IOL implantation occurred in 22.2% of PRK-treated eyes and in 13.6% of LASIK-treated eyes. CONCLUSIONS: Bioptic treatment of extreme myopia and myopia associated with astigmatism appears to be safer and more predictable than other methods of treatment.     

激光性角膜手术与眼内屈光手术矫治超高度近视眼

目的:评价及探讨矫治超高度近视眼的各类屈光手术的有效性、稳定性和安全性。方法:随机选择临床中观察到的超高度近视患者行各类屈光手术者108眼,近视范围-10.00～-24.50D,术前屈光度平均为(-12.25±1.53)D,散光平均为(-1.52±0.55)D;手术方式的选择:(1)I组52眼,行LASIK术:(2)II组23眼,行透明晶状体超声乳化摘除加后房型人工晶状体植入术。(3)III组33眼行有晶状体眼虹膜固定型人工晶状体植入术。术后随访观察平均6mo,主要观察术后裸眼视力、最佳矫正视力、屈光度、眼压及眼前段、眼底情况。结果:三组术后裸眼视力均比术前提高,术后裸眼视力≥0.5者分别是42眼(80.8%),20眼(87.0%),28眼(84.8%),术后屈光度分别为(-2.10±2.38)D,(-1.75±1.33)D,(0.83±1.16)D,主要并发症I组术后6mo黄斑出血1眼,II组术后15mo视网膜脱离1眼,III组平均角膜内皮细胞丢失率为4.5%。结论:对于超高度近视,晶状体性屈光手术效果优于LASIK术。对超高度近视行屈光手术,要根据患者年龄,眼部情况,手术医师的技术等,选择安全、有效、稳定性好的手术。     

Iris-claw phakic intraocular lens for high myopia.

PURPOSE: To evaluate the efficacy, safety, predictability, and stability of implanting a polymethylmethacrylate (PMMA) phakic intraocular lens (PIOL) (the Artisan myopia lens) to correct high myopia. METHODS: An Artisan myopia lens was implanted in 78 consecutive eyes of 49 patients with preoperative myopia that ranged from -6.25 to -28.00 D. Mean patient age was 42.4 years. Mean follow-up was 10.7 months and all patients were followed for at least 6 months; 45 eyes had follow-up of 12 months, and 10 eyes had 24 months. The desired outcome was emmetropia in all eyes except for those eyes with preoperative myopia greater then -23.00 D. RESULTS: Fifty-three eyes (67.9%) had a postoperative refraction at the last follow-up examination within +/-1.00 D of emmetropia, and 39 eyes (50.0%) had a postoperative refraction +/- within 0.50 D of emmetropia. The postoperative refraction remained stable during the entire follow-up period. Mean spectacle-corrected visual acuity improved from 20/32 preoperatively to 20/25 postoperatively. Mean postoperative uncorrected visual acuity was 20/32. There was no significant change in endothelial cell density from baseline. We did not encounter major complications. CONCLUSION: Implantation of the Artisan myopia lens to correct high myopia resulted in a stable and fairly predictable refractive outcome. A significant endothelial cell change was not detected.     

Correction of myopia of 7 to 24 diopters with the Artisan phakic intraocular lens: two-year follow-up

PURPOSE: To evaluate the safety and efficacy of the iris claw phakic intraocular lens (Artisan; Ophtec BV, Groningen, The Netherlands) in patients with high myopia. METHODS: Between May 1999 and July 2001, 93 Artisan phakic intraocular lenses (IOLs) were implanted in 60 patients affected by high myopia. All patients underwent 24-month follow-up. The power of the lenses ranged from -7.5 to -22.0 diopters (D). Patients were divided into two groups: group 1 (68 eyes), myopia -6.75 to -15.50 D (SE), and group 2 (25 eyes), myopia -16.0 to -23.0 D (SE). Pre- and postoperative patient evaluation included manifest and cycloplegic refractions, uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), endothelial cell count, intraocular pressure, complication rate, safety, and efficacy. RESULTS: At 4 months, 83.8% (57/68) (group 1, myopia -6.75 to -15.50 D) and 68% (17/25) (group 2, myopia -16.0 to -23.0 D) of eyes achieved UCVA of > or =20/40. The BSCVA remained the same or improved in 100% of eyes. After 4 months, 69.1% (47/68) of eyes in group 1 and 52% (13/25) of eyes in group 2 were within +/-1.00 D of the desired refraction; the mean refraction was stable between 4 and 24 months. Of the intraoperative complications, 69.2% were observed in the first 25 lenses implanted; postoperative complications included iris atrophy in 11.8% (11/93), lens decentration in 5.4% (5/93), and night glare in 6.4% (6/93) of eyes. No IOLs were removed. Mean endothelial cell loss was 2.8% at 4 months, 3.9% at 12 months, and 5.4% at 24 months. CONCLUSIONS: Our results regarding implantation of the Artisan phakic IOL confirm that these lenses are safe and effective for the correction of high myopia, with a stable refractive outcome but with a higher than normal rate of endothelial cell loss during 2-year follow-up.     

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.     

Changes in higher order aberrations and contrast sensitivity after implantation of a phakic artisan intraocular lens

PURPOSE: To evaluate higher-order aberrations (HOAs) and contrast sensitivity (CS), and investigate their relationship, after implantation of a phakic Artisan intraocular lens (IOL) for high myopia. METHODS: A prospective study including 25 eyes of 15 patients with high myopia (greater than -8.00 D) who underwent phakic Artisan IOL implantation was carried out. Uncorrected visual acuity (UCVA), best corrected visual acuity, manifest refraction, and pupil diameter were measured at baseline and at 1 and 3 months postoperatively. HOAs were measured by Wavescan(R) (VISX Inc., Santa Clara, Calif., USA) from the 3.0 mm pupil entrance, and CS was measured using the VCTS(R) 6500 (Vistech consultants, Inc., Dayton, Ohio, USA) under photopic conditions. The area under the log contrast sensitivity function (AULCSF), defined as the integration of the fitted third order polynomial of the log CS units between the fixed limits of 0.18 (1.5 CPD) and 1.25 (18 CPD) on the log spatial frequency scale, was calculated. RESULTS: UCVA LogMAR improved from 1.58 at baseline to 0.22 at 3 months, and spherical equivalent refraction was -0.77 +/- 0.34 D at 3 months. The total HOAs had increased slightly at 1 month. CS had decreased significantly at all cycles per degree (p < 0.05) at 1 month, but returned to baseline values at 3 months. Postoperative AULCSF did not correlate with total HOAs under photopic conditions, but correlated with UCVA LogMAR at 1 month (p = 0.037). CONCLUSIONS: Phakic Artisan IOL implantation for the correction of high myopia resulted in a small increase of HOAs under photopic conditions. At 1 month, CS was decreased, but returned to baseline at 3 months under photopic conditions. Postoperative AULCSF did not correlate with total HOAs at 1 month.     

Long-term results of correction of high myopia with an iris claw phakic intraocular lens

PURPOSE: Anterior chamber phakic intraocular lenses (PIOLs) are one of the modalities used to correct high myopia. We report the long-term results of our prospective study on the Artisan 5-mm optic myopia lens. METHODS: We studied 67 eyes of 38 consecutive patients with preoperative myopia ranging from -5.38 to -28.00 D. All patients were operated by one surgeon. Mean follow-up was 35 months (24 months in 67 eyes and 36 months in 61 eyes). RESULTS: In 45 eyes (67.2%), postoperative residual refraction was within +/- 1.00 D of emmetropia. The mean refraction was stable statistically during the entire follow-up period. Mean best spectacle-corrected visual acuity improved from 20/40 to 20/32. Mean endothelial cell loss at 6 months was 5.5% (range, -52.4% to +9.3%), at 12 months, 7.21% (range, -53.2% to +20.1%), at 24 months, 9.1% (range -43.6% to +13.6%), and at 36 months, 10.9% (range, -43.0O% to +11.4%). The majority of eyes had an increase in best spectacle-corrected visual acuity; 5 eyes lost best spectacle-corrected visual acuity. We encountered no major complications. CONCLUSION: Implanting the Artisan 5-mm optic myopia lens in high myopic eyes resulted in a stable and accurate refractive outcome. The apparent progressive corneal endothelial cell loss remains a matter of concern.     

有晶状体眼前房型人工晶状体植入矫治高度近视临床观察

目的:观察有晶状体眼Verisyse前房虹膜夹型人工晶状体植入矫治高度近视术后的视力、屈光状态以及相关并发症,评价其临床应用价值。方法:自2006-07/2008-07接受Verisyse人工晶状体植入术的32例48眼,术前平均球镜当量-15.65±3.41D。统计术后6mo;1a裸眼视力,最佳矫正视力、屈光度、内皮细胞计数,分析并发症的发生情况。结果:术后裸眼视力:0.4～1.0,平均0.75±0.34。术前最佳矫正视力:0.3～1.0,平均0.58±0.27,术后最佳矫正视力0.64±0.30。达到术前矫正42眼(87.5%),超过术前最佳矫正视力14眼(29.2%),随访6mo;1a,无明显变化。术前屈光平均球镜当量-15.65±3.41D;术后屈光度数平均球镜当量-1.58±2.47D。角膜内皮细胞计数术前(3108±265)个/mm2,术后6mo为(3054±317)个/mm2,差异无统计学意义。未见威胁视力的并发症。结论:有晶状体眼前房虹膜夹型人工晶状体植入矫治超高度近视安全有效,术后屈光效果令人满意。对眼内的长期影响需要进一步观察。     

Recovery of uncorrected visual acuity after laser in situ keratomileusis or photorefractive keratectomy for low myopia

PURPOSE: To compare uncorrected visual acuity and refractive error in patients undergoing photorefractive keratectomy (PRK) and laser in situ keratomileusis (LASIK) between 1 week and 6 months after surgery. METHODS: All eyes underwent PRK or LASIK with the VisX StarS2 excimer laser. We retrospectively analyzed data from 77 random eyes of 77 patients in the PRK group and 76 eyes of 76 patients in the LASIK group. All eyes had a low myopic refractive error (spherical equivalent range, -0.88 diopters (D) to -5.13 D; mean PRK. -2.8 +/- 0.20 D: LASIK, -2.5 +/- 0.22 D). Uncorrected visual acuity and manifest refractive error were evaluated 1 week, 1 month, and 6 months after surgery. RESULTS: Each eye undergoing PRK was paired with an eye undergoing LASIK for a similar level of spherical equivalent. Mean uncorrected visual acuity after 1 week was 0.85 +/- 0.06 (20/25, logMAR 0.12 +/- 0.04) for the PRK group and 1.01 +/- 0.06 (20/20, logMAR 0.01 +/- 0.03) for the LASIK group (p < 0.001). Mean spherical equivalent after 1 week was 0.23 +/- 0.12 D for the PRK group and -0.02 +/- 0.07 D for the LASIK group (p = 0.02). Mean uncorrected visual acuity after 1 month was 1.03 +/- 0.05 (20/20, logMAR 0.02 +/- 0.03) for the PRK group and 1.05 +/- 0.05 (20/20. -0.02 +/- 0.03) for the LASIK group (p = 0.16). Mean spherical equivalent after I month was 0.19 +/- 0.10 D for the PRK group and -0.02 +/- 0.09 D for the LASIK group. This difference was statistically significant (p = 0.02), but was unlikely to be clinically significant. Mean uncorrected visual acuity after 6 months was 1.05 +/- 0.06 (20/20, logMAR -0.01 +/- 0.03) for the PRK group and 1.06 +/- 0.05 (20/20, logMAR -0.14 +/- 0.03) for the LASIK group (p = 0.41). Mean spherical equivalent after 6 months was 0.02 +/- 0.08 D for the PRK group and 0.00 +/- 0.08 D for the LASIK group (p = 0.35). CONCLUSION: Uncorrected visual acuity 1 week after surgery is significantly better in eyes undergoing LASIK than in eyes undergoing PRK. Both procedures provide functional vision by 1 week after surgery. The difference does not relate to refractive error, which was similar between the two groups, but to differences in healing of the epithelium. By 1 month after surgery, there is no difference in mean uncorrected visual acuity between eyes that undergo PRK or LASIK for low myopia.     

Bioptics by angle-supported phakic lenses and photorefractive keratectomy

PURPOSE: To assess efficacy and safety of the combination of angle-supported phakic intraocular lenses (IOLs) and photorefractive keratectomy (PRK) for the correction of myopia and astigmatism. METHODS: Prospective, non-randomized single-surgeon study on 48 patients (76 eyes) undergoing angle-supported phakic IOL implantation with surgical peripheral iridectomy, followed 2 to 3 months later by PRK to correct residual refractive error. Twenty-three patients (33 eyes) achieved good uncorrected visual acuity with IOL implantation alone and did not undergo PRK. Thus, the study was completed by 25 patients (43 eyes) with preoperative mean defocus equivalent (DEQ) of 15.73 D (SD 4.67 D) and mean astigmatism of -2.87 D (SD 1.39 D). RESULTS: Eight months after PRK, mean spherical equivalent was -0.08. Mean DEQ was 0.47 D (SD 0.37); 42/43 eyes (98%) were within +/-1 D of DEQ, and 33/43 eyes (77%) within +/-0.5 D. Mean uncorrected visual acuity was 0.7 (SD 1.9). Safety index was 1.25; efficacy index 1.11. Best-corrected visual acuity improvement (0.16) was statistically significant (95% CI: 1.1 to 2). Halos were moderate in 6/25 patients (24%); severe in 1/25 patients (4%). Endothelial cell density decreased by -6.6%. Pain after PRK was severe in 3/25 patients (12%) and moderate in 13/25 patients (52%). Complications were recurrent iridocyclitis in one eye, transient ocular hypertension in two eyes, and incomplete iridectomy in one eye. CONCLUSIONS: Angle-supported phakic IOLs followed by adjustment by PRK offer good efficacy, predictability, and safety to manage large refractive myopic errors.