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.     

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.     

Correction of high myopia with anterior chamber angle-supported phakic intraocular lenses--own results

PURPOSE: To evaluate the early results: predictability, efficacy and safety of implanting new model of anterior chamber IOL for high myopia. MATERIAL AND METHODS: ICARE myopia lens (Corneal) was implanted in 20 eyes of 12 patients with preoperative myopia that ranged from -10 D to 23.5 D. Mean patient age was 32.3 years. The follow-up period was 6 months. The desired outcome was emmetropia. RESULTS: Eighteen eyes (85%) had a postoperative refraction at the last follow-up examination in a range +/- 1.0 D of emmetropia. The postoperative refraction remained stable during the entire follow-up period. Mean visual acuity before surgery, corrected with spectacle improved from 0.5 to 0.68 postoperatively without glasses in 3 months time. There was no loss in visual acuity after operation. We didn't encounter major complications. Mean endothelial cell density reduction was 3.2% in our 3 months study. CONCLUSIONS: Implantation of ICARE myopia lens to correct high myopia resulted in a stable and predictable refractive outcome. Further investigation is necessary to evaluate long-term stability and safety of this procedure.     

Combined surgery to correct high myopia: iris claw phakic intraocular lens and laser in situ keratomileusis.

PURPOSE: To evaluate the results of combined surgery, implantation of an Artisan phakic iris claw intraocular lens (IOL) followed by laser in situ keratomileusis (LASIK) to correct high myopia. METHODS: A prospective study of 6 patients (8 eyes) with high myopia who had Artisan phakic IOL implantation followed by LASIK was undertaken. The IOL was a standard -15.00-D, 6-mm diameter optical zone. Residual refractive error was corrected by LASIK. Mean follow-up was 16 +/- 4 months (range, 12 to 20 mo). RESULTS: After the second procedure (LASIK), uncorrected visual acuity ranged from 0.4 to 0.63 (mean, 0.5 +/- 0.07) at 1 month and from 0.6 to 0.7 (mean, 0.62 +/- 0.04) at 12 months. Spectacle-corrected visual acuity improved 2 or more lines in 62.5% (5 eyes) from preoperative values. Mean postoperative spherical equivalent refraction was -0.68 +/- 0.23 at 1 month and -0.35 +/- 0.22 at 12 months after LASIK. All eyes were within +/-1.00 D of emmetropia following the LASIK portion of the two-stage procedure and 5 eyes were within +/-0.50 D. We had no major complications. No significant endothelial damage occurred. CONCLUSIONS: The accurate refractive outcome, absence of major complications, stability of results, and most important, improvement in quality of vision (defined as no change in vision when illumination conditions varied, eg, at night) experienced by these highly myopic patients are reasons to continue using and improving this combined technique.     

Iris-claw phakic (Artisan) lens to correct high myopia

PURPOSE: To assess the safety and efficacy of the iris claw phakic (6mm Artisan lens) in patients with high myopia. METHODS: Twenty-five eyes with myopia of -7.50 to 16D were implanted with a 6mm artisan lens and followed for 24 months. RESULTS: The mean preoperative spherical equivalent refraction was 13.08+/-3.44D at one year. Mean operative spherical equivalent refraction was 0. 77+/-0.57D and 81.8% of eyes had a spherical equivalent refraction within +/-1.00D. Best spectacle-corrected visual acuity was maintained or improved in 62.5% of cases. No iritis or cataract or glaucoma was observed. CONCLUSION: Implantation with the 6mm Artisan lens is an effective method for reducing or correcting myopia up to -16D. Gains in spectacle corrected visual acuity were common, and results suggested good predictability. Because of the incomplete follow up, we cannot draw conclusions about the long term safety of the 6mm Artisan lens.     

Laser in situ keratomileusis for myopia of -1.50 to -6.00 diopters

PURPOSE: To evaluate the results of laser in situ keratomileusis (LASIK) for the correction of low and moderate myopia and astigmatism using the Nidek EC-5000 excimer laser with a modified algorithm. METHODS: Three hundred and ninety-six eyes of 257 patients with myopia ranging from -1.50 to -6.00 D and astigmatism of no more than 4.00 D were included. Manifest spherical equivalent refraction, uncorrected and spectacle-corrected visual acuity were assessed at 1 month (357 eyes, 90%), 3 months (220 eyes, 56%), and 6 months (168 eyes, 42%) after LASIK. RESULTS: Mean preoperative spherical equivalent refraction was -3.60 +/- 1.27 D and mean cylinder was -1.01 +/- 1.08 D. Mean postoperative spherical equivalent refraction was -0.12 +/- 0.31 D and mean cylinder was -0.19 +/- 0.33 D. At 6 months follow-up, 158 eyes (94%) had a mean postoperative spherical equivalent refraction within +/- 0.50 D of emmetropia; 168 eyes (100%) were within +/- 1.00 D. Uncorrected visual acuity was 20/20 or better in 81% (136 eyes) and 20/40 or better in 100%. Two eyes (1.2%) lost 1 line of spectacle-corrected visual acuity due to a decentered ablation. No eye lost 2 or more lines of spectacle-corrected visual acuity. CONCLUSION: Our modified LASIK algorithm with the Nidek EC-5000 excimer laser resulted in safe and predictable outcomes for treatment of low and moderate amounts of myopia and astigmatism.     

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.     

Experience with the Artisan phakic intraocular lens in Asian eyes

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

Artisan toric phakic intraocular lens for the correction of high astigmatism

PURPOSE: To evaluate efficacy, predictability, and safety of Artisan toric phakic intraocular lens (Ophtec, Groningen, The Netherlands) implantation for the correction of astigmatism higher than 2 diopters. DESIGN: Interventional case series. METHODS: This prospective study included 27 eyes of 16 patients with a mean preoperative spherical equivalent of -11.78 +/- 6.24 diopters and a mean preoperative astigmatism of -3.43 +/- 0.81. The Artisan phakic intraocular lens was inserted in the anterior chamber through a posterior corneal incision; the technique is similar to the implantation of the classical Artisan lens, but in these cases it is particularly important to secure the lens accurately in the correct axis. The main parameters evaluated in this study were uncorrected visual acuity, best-corrected visual acuity, refraction, and endothelial cell count. RESULTS: Twelve months after the implantation of the Artisan toric phakic intraocular lens, 62.90% of the eyes were within +/-0.50 diopters. of emmetropia and 96.20% within +/-1.0 diopters. Seventy percent of the eyes gained 1 or more Snellen lines from their preoperative best-corrected visual acuity, and 11.11% lost 1 Snellen line. Mean endothelial cell count increased 2.9%. Mean of the parallel and orthogonal components of cylinder correction were 1.97 diopters and 0.10 diopters, respectively, of the intended cylinder change. The mean of axis alignment error was 10.53 degrees. No serious complications were observed. CONCLUSION: Artisan toric phakic intraocular lens implantation appears to be a safe and predictable method for the correction of high levels of astigmatism.     

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.     

Toric phakic intraocular lens for the correction of hyperopia and astigmatism

PURPOSE: To evaluate the Artisan toric phakic intraocular lens (pIOL) for the correction of hyperopia and astigmatism. SETTING: Department of Ophthalmology, Erasmus MC, Rotterdam, The Netherlands, and Department of Ophthalmology, Sint Truiden, Belgium. METHODS: In this prospective study of 47 eyes of 28 patients with hyperopia and astigmatism, Artisan toric pIOLs were implanted between April 1999 and June 2004. Uncorrected visual acuity (UCVA), best corrected visual acuity, refraction, astigmatism, safety, and predictability were analyzed. Change in astigmatism was analyzed with vector analysis. Refractive cylinders are expressed in minus form. RESULTS: Mean preoperative spherical equivalent was +4.33 diopters (D) +/- 2.26 (SD). Mean follow-up was 11.1 months (range 6 to 36 months). A gain of 1 or more lines in best spectacle-corrected visual acuity (BSCVA) was seen in 36.2%. Safety index and efficacy index after 6 months were 1.06 and 0.87, respectively. The mean postoperative astigmatism at 6 months was 0.19 D at an axis of 144 degrees. At 6 months, about three quarters (76.6%) of the eyes had a UCVA of 20/40 or better. One eye lost 2 lines of BSCVA. In 1 eye, the lens position had to be changed because of a large axis misalignment. No serious complications developed in any of the treated eyes during follow-up. CONCLUSIONS: Artisan toric pIOLs can correct moderate to high hyperopia combined with astigmatism with good refractive results. In this study, there were no serious complications. However, the predictability of the refractive results appeared to be lower than those in the correction of myopia and astigmatism with toric Artisan lenses.     

Multicenter study of the Artisan phakic intraocular lens

PURPOSE: To assess the Artisan intraocular lens to correct myopia in phakic eyes. SETTING: European multicenter study sponsored by Ophtec BV, Groningen, The Netherlands. METHODS: In this prospective multicenter clinical study, the Artisan lens was implanted in 518 eyes between September 1991 and October 1999. The power of the lenses ranged from -5.0 to -20.0 diopters (D). Follow-up examinations were performed at 6 months and 1, 2, and 3 years. Follow-up ranged from 6 months (n = 454) to 3 years (n = 249). The preoperative uncorrected visual acuity (UCVA) was not recorded but was estimated to be worse than 0.1. The preoperative mean best spectacle-corrected visual acuity (BSCVA) was 0.67 +/- 0.26 (SD). Endothelial cell counts were done at 6 months and 1, 2, and 3 years in a subgroup of 129 eyes. RESULTS: A UCVA of 20/40 or better was observed in 76.8% of eyes regardless of the postoperative goal. A BSCVA of 20/40 or better was observed in 93.9% of eyes and remained stable throughout the follow-up. Of the eyes with extremely high myopia (>-15.0 D), 63.3% gained 2 or more lines of BSCVA; of those with moderate myopia (-5.0 to -10.0 D), 23.5% gained 2 or more lines. The mean endothelial cell density change was 4.8% at 6 months, 2.4% at 1 year, 1.7% at 2 years, and 0.7% at 3 years. The incidence of persistent adverse events at 3 years was relatively low. Secondary surgical interventions included repositioning of the lens because of poor initial placement and lens exchange because of preoperative power calculation errors. Glare and halo effects during night driving were noted and were related to large pupils in young patients. CONCLUSION: The Artisan lens is a safe, stable, efficacious, and predictable method to correct -5.0 to -20.0 D of myopia. This study suggests that the corneal endothelial cell loss is stabilized to the physiologically normal level after 3 years.     

Laser in situ keratomileusis for myopia and hyperopia using the Lasersight 200 laser in 300 consecutive eyes

PURPOSE: To evaluate effectiveness, safety, predictability, and short-term stability of laser in situ keratomileusis (LASIK) using the LaserSight Compac-200 Mini excimer laser with software version 9.0, for all refractive errors. METHODS: One hundred fifty consecutive patients (300 eyes) that received bilateral LASIK for myopia, hyperopia, and astigmatism were studied prospectively. A new 9.0 software version applying a modified nomogram that takes advantage of bilateral surgery was used. Follow-up at 6 months was available for 267 eyes (89%). RESULTS: Six months postoperatively, 131 eyes (96.32%) in the low to moderate myopia group (-1.00 to -5.99 D; n=136) had a spherical equivalent refraction within +/-1.00 D, and 123 eyes (90.44%) were within +/-0.50 D of emmetropia. In the high to extreme myopia group (-6.00 to -25.00 D; n=114), 97 eyes (87.08%) had a spherical equivalent refraction within +/-1.00 D and 78 eyes (68.42%) were within +/-0.50 D of emmetropia. In the hyperopia group (+1.00 to +6.00 D; n=50), 44 eyes (88%) had a postoperative spherical equivalent refraction within +/-1.00 D, and 31 eyes (62%) were within +/-0.50 D of emmetropia. Mean change in spherical equivalent refraction at 6 months was less than -0.50 D in the low to high myopia groups and -1.16 +/- 0.55 D in the extreme myopia group. At 6 months follow-up, uncorrected visual acuity was 20/20 or better in 73 eyes (54%) in the low to moderate myopia groups and 21 eyes (18%) in the high to extreme myopia groups. In the hyperopia group at 6 months follow-up, uncorrected visual acuity was 20/20 or better in 31 eyes (62%) and 20/40 or better in 41 eyes (82%). Only two eyes had a temporary loss of two or more lines of spectacle-corrected visual acuity due to corneal folds that were surgically treated. Six months after LASIK, no eye had lost any lines of best spectacle-corrected visual acuity in this series. CONCLUSIONS: Our modified LASIK nomogram with the 9.0 software of the LaserSight 200 excimer laser (with a larger and smoother ablation pattern) resulted in safe and effective outcomes for the treatment of low to high myopia, astigmatism, and hyperopia.     

Artisan phakic intraocular lens for myopia:short-term results of a prospective,multicenter study

PURPOSE: To evaluate the safety and efficiency of the Artisan iris-supported phakic intraocular lens (Ophtec BV, Groningen, Netherlands) for the correction of high myopia. STUDY DESIGN: Nonrandomized, prospective, multicenter trial conducted under a United States Food and Drug Administration (FDA) Investigational Device Exemption. PARTICIPANTS: One hundred fifty-five eyes of 155 patients with myopia from -5.5 to -22.5 diopters (D) underwent implantation of an Artisan lens, as part of a phase I, II, or III FDA trial. METHODS: Eyes were examined at 1 day (154 eyes), 2 weeks (142 eyes), 2 months (130 eyes), and 6 months (84 eyes). Intraocular pressure and presence of flare and cell on slit-lamp biomicroscopy were recorded at each visit. MAIN OUTCOME MEASURES: Achieved correction, stability of spherical equivalent refraction, change in astigmatism, postoperative uncorrected vision, change in best spectacle-corrected acuity, and change in endothelial cell count. RESULTS: Mean spherical equivalent manifest refraction stabilized on postoperative day 1. Mean difference between attempted and achieved correction at 2 months was -0.32 +/- 0.95 D (mean +/- standard deviation; range, -4.42 to +2.2 D). At 6 months, 85% of eyes saw 20/40 or better uncorrected, and 90% of eyes were within 1 D of the attempted correction. Refractive astigmatism increased in 4.8% of eyes and decreased in 17% of eyes at 6 months. At 2 months, six eyes (4.8%) lost two or more lines of best spectacle-corrected visual acuity; by 6 months, no eyes lost two or more lines of best-corrected visual acuity. Endothelial cell count was unchanged at 6 months compared with the preoperative count. Nonprogressive lens opacities developed in four eyes as a result of surgical trauma. Chronic inflammation was not detected in any eye by slit-lamp biomicroscopy, nor did any eye develop angle closure or glaucoma. CONCLUSIONS: Short-term results suggest that the Artisan lens is an accurate and safe method for the correction of high myopia. Surgical skill is important in avoiding lens opacities. Longer-term data are needed to assess the impact of the lens on the endothelium, the crystalline lens, and the iris.     

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.     

The Kelman Duet phakic intraocular lens: 1-year results

PURPOSE: To evaluate the efficacy and safety of the Kelman Duet phakic intraocular lens (PIOL) for correction of moderate and high myopia. METHODS: Kelman Duet PIOLs were implanted in 169 eyes of 110 patients with moderate or high myopia. In all cases, implantation of the lens was feasible through an incision of less than 2.5 mm without complications. Uncorrected visual acuity (UCVA), manifest refraction, best spectacle-corrected visual acuity (BSCVA), intraocular pressure, central corneal endothelial change, and complications were recorded preoperatively and during 12 months of follow-up. RESULTS: Following PIOL implantation, 23 (13.61%) eyes required LASIK retreatment for the correction of residual astigmatic refractive error and were excluded from the refractive analysis. Best spectacle-corrected visual acuity remained the same or improved in 95.04% of eyes, 81.30% of eyes (100) were within +/-1.00 diopter (D) of emmetropia, and 57.72% (71) were within +/-0.50 D. Intraocular pressure increased slightly in the first 4 weeks postoperatively but stabilized to the preoperative level by 3 months. Mean endothelial cell loss at 12 months was 5.43%. Oval pupils developed in 10.1% of eyes. Haptic exchange or reposition was performed in 7.76% of cases. CONCLUSIONS: The Kelman Duet PIOL was safe and effective for the correction of moderate to high myopia in this study with 1-year follow-up and offered the advantage of using a 2.5-mm or less incision width. Accurate haptic sizing remains a challenge and haptic exchange to correct haptic size mismatching is possible.     

Postoperative astigmatism and rotational stability after artisan toric phakic intraocular lens implantation

PURPOSE: To evaluate deviations in the axis (intended versus achieved) and postoperative astigmatism after implantation of an Artisan toric phakic intraocular lens (IOL). SETTING: University Eye Hospital, Mainz, Germany. METHODS: This prospective study comprised 29 eyes with high ametropia and astigmatism. All eyes had uneventful implantation of a toric phakic IOL through a superior scleral tunnel incision at 12 o'clock. After a minimum of 6 months, the uncorrected visual acuity (UCVA), best correct visual acuity, refraction, and astigmatism were analyzed in all eyes. A multivariate analysis of postoperative astigmatism was performed. RESULTS: After a follow-up of at least 6 months, 95% of eyes were within +/-1.00 diopter (D) of emmetropia and 85% of eyes has a UCVA of 20/30 or better. The difference between the mean intended cylinder axis and achieved cylinder axis was 3.9 degrees (median 3 degrees; range to 13 degrees). The difference between the mean intended axis and the achieved axis between miosis and mydriasis was 1.8 degrees (median 1.5 degrees; range 0 to 5 degrees). The mean postoperative astigmatism after 6 months was 0.56 D with an axis of 31 degrees. Doubled-angle scatterplot analysis showed a tendency toward more flattening in the vertical meridian. CONCLUSIONS: During the 6-month follow-up, no significant rotation was observed after implantation of Artisan toric phakic IOLs to correct high ametropia. A sutureless sclerocorneal superior approach for phakic IOL insertion resulted in moderate to low astigmatism. Induced astigmatism should be taken into consideration during preoperative planning.     

Laser in situ keratomileusis for undercorrection after radial keratotomy.

PURPOSE: To assess the safety and efficacy of excimer laser in situ keratomileusis (LASIK) in treating residual myopia and/or astigmatism following refractive keratotomy. METHODS: Fourteen eyes that had previously undergone radial and/or arcuate keratotomy were included. The surgeries were performed using the Chiron Automated Microkeratome and the VISX 20/20B excimer laser. RESULTS: Average follow-up was 12.64+/-5.02 months. Mean spherical equivalent refraction was reduced from -3.48+/-3.52 D preoperatively to -0.04+/-0.87 D postoperatively. At the last follow-up examination there were 8 eyes (57.1%) with a refraction within+/-0.50 D, and 10 eyes (71.4%) within +/-1.00 D of emmetropia. Uncorrected visual acuity was 20/20 or better in 4 eyes (28.6%) and 20/40 or better in 10 eyes (71.4%). Vector analysis of the astigmatic correction showed an index of success of 80%. There was no significant loss (> or = or =2 lines) of spectacle-corrected visual acuity. We observed interface epithelial ingrowth in one eye. CONCLUSIONS: The correction of residual myopia and/or astigmatism with LASIK in eyes with prior refractive keratotomy proved to be safe and effective. Careful preoperative evaluation may help to avoid complications such as reopening of incisions during surgery or postoperative ingrowth of epithelium beneath the corneal flap.     

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.