Artisan phakic iris claw intraocular lens for high primary and secondary hyperopia

PURPOSE: To evaluate the efficacy, predictability, and safety of the Artisan iris claw phakic intraocular lens for the correction of high primary and secondary hyperopia. METHODS: Fifty-seven eyes were divided into two groups: 29 eyes had primary hyperopia (mean refraction 6.06 +/- 1.26 D, and 28 eyes had secondary hyperopia, (mean refraction 5.88 +/- 1.88 D) induced or residual following a previous corneal refractive procedure. Consecutive implantation of the Artisan iris claw phakic intraocular lens was performed. Main outcome measures recorded were BSCVA, UCVA, refraction, and astigmatic change, intraocular inflammation, and endothelial cell loss. RESULTS: Primary hyperopic group: Preoperatively, mean UCVA was 0.4 +/- 0.7 and mean BSCVA was 0.2 +/- 0.6. After implantation, mean UCVA was 0.3 +/- 0.6 and BSCVA was 0.1 +/- 0.6. Mean cycloplegic residual spherical refractive error after surgery was 0.10 +/- 0.57 D (range -1 to +2 D). Mean surgically induced astigmatism was 1.48 +/- 0.89 D. Safety index was 1.11. Efficacy index was 0.83. Secondary hyperopic group: Preoperatively, mean UCVA was 0.5 +/- 0.7 and mean BSCVA was 0.2 +/- 0.6. Postoperatively, mean UCVA was 0.4 +/- 0.7 and mean BSCVA was 0.2 +/- 0.6. Mean cycloplegic residual spherical refractive error was 0.55 +/- 1.49 D. Mean surgically induced astigmatism was 1.85 +/- 1.19 D. Safety index was 1.05. Efficacy index was 0.7. Postoperative iridocyclitis was observed in one eye (3.4%) in the primary group and in three eyes (10.7%) in the secondary group. Overall corneal endothelial cell loss at 1 year of follow-up was 9.4%. CONCLUSION: The Artisan iris claw phakic intraocular lens was reasonably safe and predictable for correcting high hyperopia.     

Phakic refractive lens (Medennium) for correction of +4.00 to +6.00 diopters: 1-year follow-up

PURPOSE: To study the efficacy and safety of phakic refractive lens (PRL) implantation to correct high hyperopia. METHODS: Inclusion criteria for this prospective, observer-masked, interventional study were spherical equivalent > or =+4.00 diopters (D) of cycloplegic hyperopia, best spectacle-corrected visual acuity (BSCVA) > or =0.5, anterior chamber depth > or =3 mm, and mesopic pupil size < or =6 mm. Lenses were implanted in all cases under regional anesthesia using forceps. RESULTS: Sixteen eyes of nine patients were included in the study. Mean preoperative spherical equivalent refraction was +5.65+/-1.41 D (range: +3.25 to +5.75 D). Mean 1-year postoperative spherical equivalent refraction was +0.07+/-0.43 D (range: -0.50 to 0.75 D). Fifteen (93.75%) eyes were within +/-0.50 D of emmetropia, and 16 (100%) eyes were within +/-1.00 D of emmetropia. Safety and efficacy indexes were 0.9 and 0.8, respectively. Eight (50%) eyes needed LASIK to correct residual astigmatism. Five (31.25%) eyes lost one line of BSCVA; no eye lost two or more lines of BSCVA. The BSCVA did not increase in any eye. No significant intraocular complications developed. CONCLUSIONS: Phakic refractive lens implantation to correct high hyperopia seems to be a safe and accurate procedure. A mild but significant loss in BSCVA can be anticipated.     

Toric phakic intraocular lens: European multicenter study

OBJECTIVE: To evaluate safety, efficacy, predictability, stability, complications, and patient satisfaction after implantation of Artisan toric phakic intraocular lenses (TPIOLs) for the correction of myopia or hyperopia with astigmatism. DESIGN: Prospective, nonrandomized, comparative (self-controlled) multicenter trial. PARTICIPANTS: Seventy eyes of 53 patients (mean, 35 years; range, 22-59 years) with preoperative spherical equivalent between +6.50 and -21.25 diopters (D) and cylinder between 1.50 and 7.25 D. METHODS: Seventy eyes underwent implantation of a TPIOL with an optical zone of 5.0 mm (Artisan, Ophtec, Groningen, The Netherlands). The dioptric power of the intraocular lens was calculated by considering refraction, keratometry, and anterior chamber depth. The follow-up was 6 months in all cases. Lenses were available in powers ranging from +12.0 D to -23.5 D (spherical equivalent) in 0.5-D increments, with additional cylinder from 1.0 D to 7.0 D, also in 0.5-D increments. MAIN OUTCOME MEASURES: The main parameters assessed were best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), refraction, endothelial cell count (ECC), intraocular pressure, slit-lamp biomicroscopy, indirect ophthalmoscopy, subjective complaints, and patient satisfaction. RESULTS: Eyes were divided into group A, myopia (n = 48), with an average preoperative spherical equivalent of -8.90 +/- 4.52 D, and group B, hyperopia (n = 22), with an average preoperative spherical equivalent of +3.25 +/- 1.98 D. No eyes in either group experienced a loss in BSCVA, and 46 eyes gained 1 or more lines of their preoperative BSCVA. In 62 eyes (88.6%), UCVA was 20/40 or better. There was a significant reduction in spherical errors and astigmatism in all cases after surgery. All eyes of both groups were within +/-1.00 D of target refraction, and 51 eyes (72.9%) were within +/-0.50 D of target refraction. There was a 4.5% mean total loss of ECC during the first 6 months. No serious complications were observed. Overall patient satisfaction was very high. CONCLUSIONS: Six-month clinical trial results demonstrate that implantation of the Artisan TPIOL safely, predictably, and effectively reduced or eliminated high ametropia and astigmatism with one procedure. The refractive effect was stable at 6 months after surgery.     

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.     

Refractive lens exchange with an array multifocal intraocular lens

PURPOSE: To prospectively evaluate safety, efficacy, predictability, stability, complications, and patient satisfaction after refractive lens exchange (clear lens extraction) followed by posterior chamber implantation of a multifocal intraocular lens (IOL). METHODS: Fifty eyes of 25 patients (mean age 51 years, range 44 to 62 years) with preoperative spherical equivalent refraction between -15.50 and +5.75 D and cylinder between 0 and 1.50 D underwent bilateral implantation of a zonal progressive multifocal IOL (Array, AMO). RESULTS: Eyes were divided into group A (n=24; myopia, average preoperative spherical equivalent refraction -7.11 +/- 3.25 D (-1.75 to -15.50 D), and group B (n=26; hyperopia, average preoperative spherical equivalent refraction +3.04 +/- 1.04 D). Follow-up was 6 months in all eyes. Postoperatively, all eyes of both groups were within +/-1.00 D of target refraction. No eye in group A and three eyes in group B sustained a loss of one line of BSCVA. Forty-seven eyes (94%) remained unchanged or gained one or more lines of their preoperative BSCVA. In all eyes, postoperative UCVA was 20/40 or better. When compared to preoperative, uncorrected near visual acuity improved (statistically significant). All patients achieved uncorrected binocular visual acuity of 20/30 and J4 or better. Patient satisfaction was extremely high; no intra- or postoperative complications were reported. CONCLUSION: Six-month results of implantation of the AMO Array multifocal IOL for refractive lens exchange demonstrated safety, efficacy, and predictability in correcting high ametropia and significant improvement of uncorrected near and distance visual acuity.     

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.     

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.     

Clear lens extraction with intraocular lens followed by photorefractive keratectomy or laser in situ keratomileusis

OBJECTIVE: To study photorefractive keratectomy (PRK) or laser in situ keratomileusis (LASIK) after clear lens extraction (CLE) with intraocular lens (IOL) implantation for hyperopia or astigmatism. DESIGN: Retrospective, noncomparative interventional case series. PARTICIPANTS: Sixty-five eyes (55 subjects) had CLE with posterior chamber IOL implants for hyperopia up to 12.25 diopters (D); 31 eyes were retreated with PRK, and 34 eyes were retreated with LASIK for residual ametropias. INTERVENTION: For PRK and LASIK, the refractive surgery was performed with the slit-scanning excimer laser Nidek EC-5000, Nidek Co., Tokyo, Japan. MAIN OUTCOME MEASURES: Manifest refraction, best-spectacle and uncorrected Snellen visual acuity, haze, and halos were evaluated before surgery and at 1, 3, 6, and 12 months postoperative. RESULTS: Forty-seven eyes were evaluated at the 12-month postoperative examination: 96% of these eyes had spherical equivalents (SE) within +/-2 D of emmetropia, 79% of eyes had SE within +/-1 D of emmetropia and 51% of eyes had SE within +/-0.50 D of emmetropia. Eighty-five percent of the eyes at 12 months postoperative had uncorrected visual acuity of 20/40 or better, and 46% of eyes had uncorrected visual acuity of 20/20 or better. Eighty-seven percent of the eyes at 12 months postoperative had uncorrected visual acuity within 1 Snellen line of their initial best spectacle-corrected visual acuity (BSCVA) before all treatment. No eye lost 2 Snellen lines of BSCVA at 3, 6, or 12 months after PRK or after LASIK. CONCLUSIONS: IOL implantation for CLE, although an invasive technique, resulted in better refractive outcomes without laser-related clinical complications after PRK or LASIK adjustment.     

Artisan iris-fixated toric phakic and aphakic intraocular lens implantation for the correction of astigmatic refractive error after radial keratotomy

We report 2 patients who had radial keratotomy (RK) to correct myopia. The first patient developed a postoperative hyperopic shift and cataract. Nine years post RK, she had intracapsular cataract extraction and implantation of an Artisan aphakic intraocular lens (IOL). Twenty years post RK, hyperopia and astigmatism progressed to +7.0 -5.75 x 100 with a best corrected visual acuity (BCVA) of 20/20. Due to contact lens intolerance, the Artisan aphakic IOL was exchanged for an Artisan toric aphakic IOL. Three months later, the BCVA was 20/20 with +1.0 -0.50 x 130. The second patient demonstrated residual myopic astigmatism 6 years after bilateral RK and had become contact-lens intolerant. An Artisan toric phakic IOL was implanted in both eyes. Four months later, the BCVA was 20/25 with a refraction of +0.25 -1.0 x 135 and 20/20 with a refraction of -1.0 x 40. Both patients were satisfied with the visual outcomes.     

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.     

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.     

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.     

Implantation of an Artisan phakic intraocular lens for the correction of high myopia after penetrating keratoplasty

We report 2 cases in which an Artisan phakic intraocular lens (IOL) (Ophtec) was used to successfully treat high myopia after penetrating keratoplasty (PKP). The first case was a 43-year-old man who had a manifest refraction of -13.75 +3.00 x 50 with a best corrected visual acuity (BCVA) of 20/40(-2) after PKP in the left eye. Approximately 9 months after implantation of the Artisan IOL, the manifest refraction was -2.00 +2.50 x 60 with a BCVA of 20/30(+2). The second case was a 31-year-old man who had a manifest refraction of -10.75 +2.25 x 122 and a BCVA of 20/40 after corneal transplantation in the right eye. Ten months after implantation of the Artisan IOL, the manifest refraction was -2.75 +4.75 x 80 with a BCVA of 20/40. Endothelial cell density did not change significantly in either patient after surgery. The Artisan phakic IOL may provide an alternative method to correct high myopia after PKP.     

Pseudophakic ametropia managed with a phakic posterior chamber intraocular lens

We report the use of a phakic posterior chamber intraocular lens (IOL) to correct pseudophakic ametropia. Two eyes of 2 patients developed ametropia after unilateral phacoemulsification and IOL implantation. The manifest refraction was -6.00 -0.50 x 50 in the first patient and +4.50 -1.00 x 15 in the second. Both patients were bothered by the induced anisometropia and had posterior chamber phakic IOL implantation in the pseudophakic eye. Postoperatively, uncorrected visual acuity improved from 20/400 to 20/30 in the first patient and from 20/200 to 20/40 in the second patient. The manifest refraction was -0.50 -0.75 x 55 and +1.50 -1.50 x 30, respectively. No complications were noted. Implantation of a phakic posterior chamber IOL may be an alternative to currently available methods of managing pseudophakic ametropia.     

Correction of extreme hyperopia: artisan iris-fixated intraocular lens implantation for pseudophakia after clear lens extraction

A 22-year-old patient suffering from both-side extreme hyperopia with amblyopia was corrected with an Artisan iris-fixated intraocular lens (IOL) implantation followed to clear lens extraction (CLE) with posterior chamber (PC)-IOL implantation. The preoperative refraction values were +17.75DS -1.50DC × 168° for the right eye and +17.25DS -0.75DC × 8° for the left eye. The uncorrected visual acuity (UCVA) was 20/200 bilaterally and the spectacle-corrected visual acuity (BSCVA) was 20/50 bilaterally. One year after Artisan iris-fixated IOL implantation, bilateral BSCVA was 20/50 with a refraction of +1.25DS -0.75DC × 13° for the right eye and +1.50DS -1.00DC × 55° for the left eye. The outcomes of an Artisan iris-fixated IOL implantation followed to CLE with PC-IOL implantation were encouraging for the correction of extreme hyperopia. Long term follow-up examinations were necessary for further determination of the efficacy and safety of this combinational procedure.     

Posterior chamber phakic intraocular lens for hyperopia.

PURPOSE: A Phase I U.S. FDA clinical study of a plate haptic posterior chamber phakic intraocular lens (STAAR Surgical Implantable Contact Lens) for treatment of hyperopia was conducted at 4 sites in the United States. The purpose of this report is to assess the short-term safety and efficacy. METHODS: Ten patients with hyperopia between +2.50 and +10.875 D were implanted in one eye each with the posterior chamber plate phakic intraocular lens and were examined at baseline and 1 day, 1 week, 1, 3, and 6 months after surgery. Mean baseline hyperopia was +6.63 D. RESULTS: At 6 months postoperatively, 7 of 10 eyes (70%) had an uncorrected visual acuity of 20/20 or better and 10 of 10 (100%) had 20/40 or better. Eight of ten eyes (80%) had a spectacle-corrected visual acuity within 1 line of baseline; the other two eyes (20%) had an improvement of 3 lines. Mean 6-month postoperative spherical equivalent refraction was +0.20 +/- 0.61D (range, -0.50 to +1.50 D), a reduction of 6.025 D from baseline. Eight of 10 eyes (80%) were within +/-0.50 D of emmetropia, 9 eyes (90%) were within +/-1.00 D, and all eyes (100%) were within +/-1.50 D. No operative or postoperative complications or adverse reactions were observed. CONCLUSIONS: Results support the short-term safety, efficacy, and predictability of the STAAR Surgical Implantable Contact Lens (plate haptic posterior chamber phakic intraocular lens) in the treatment of hyperopia.     

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.     

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.     

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.     

Artisan phakic intraocular lens implantation after retinal detachment surgery

PURPOSE: To report three cases of Artisan phakic intraocular lens (PIOL) implantation to correct myopic refractive error after previous retinal detachment surgery treated with scleral encircling. METHODS: Artisan PIOLs were implanted in a 29-year-old man with -21.0 -2.0 x 180 manifest refraction and best spectacle-corrected visual acuity (BSCVA) of 20/40 (case 1), a 28-year-old woman with BSCVA of 20/20 and -8.5 -1.0 x 180 manifest refraction (case 2), and a 44-year-old man with BSCVA of 20/32 and -11.75 -1.75 x 10 manifest refraction (case 3). RESULTS: In case 1, 24 months after implantation of the Artisan PIOL, uncorrected visual acuity (UCVA) was 20/40. In case 2, 24 months after surgery, UCVA was 20/32. In case 3, 3 months after surgery, UCVA was 20/32. There was no formation of new breaks, progressive vitreoretinal traction, or complications. CONCLUSIONS: The Artisan PIOL may provide an alternative method to correct high myopia after retinal detachment surgery.