Artisan Toric Phakic Intraocular Lens Research Articles

Long-Term Endothelial Cell Loss in Patients with Artisan Myopia and Artisan Toric Phakic Intraocular Lenses: 5- and 10-Year Results

To evaluate the long-term change in endothelial cell density (ECD) after the implantation of 2 types of rigid iris-fixated phakic intraocular lenses (pIOLs) for the treatment of myopia and astigmatism. Prospective, clinical cohort study. A total of 507 eyes of 289 patients receiving the Artisan Myopia or Artisan Toric (Ophtec B.V., Groningen, The Netherlands) iris-fixated pIOL for the treatment of myopia or astigmatism at the University Eye Clinic Maastricht as of January1998. A total of 381 myopic and 126 toric pIOLs were implanted. Five- and 10-year follow-ups were completed by 193 and 127 eyes implanted with the myopic pIOL and by 40 and 20 eyes implanted with the toric pIOL, respectively. Chronic endothelial cell (EC) loss, percentage of eyes with a decrease of ≥25% in ECD, and percentage of eyes with an ECD <1500 cells/mm2. Chronic EC loss was calculated from 6 months postoperatively to the end of follow-up and showed an annual ECD decline of 48 cells/mm2 (standard error, 3.14) and 61 cells/mm2 (standard error, 6.30) in the myopic (P < 0.001) and toric (P < 0.001) groups, respectively, resulting in a total EC loss of 16.6% and 21.5% from 6 months to 10 years postoperatively, respectively. Ten years after implantation, ECD had decreased by ≥25% in 7.9% and 6.3%, whereas ECD was <1500 cells/mm2 in 3.9% and 4.0% in the myopic and toric groups, respectively. Explantation of the pIOL occurred in 6.0% in the myopic group and 4.8% in the toric group. Risk factors for increased EC loss were a shallow anterior chamber depth (ACD) (P ≤ 0.005) and a smaller distance between the central and peripheral pIOL edge to the endothelium (P ≤ 0.005). A significant linear chronic EC loss was reported after implantation with myopic or toric iris-fixated pIOLs. A smaller ACD and smaller distance between pIOL edge and endothelium were risk factors for EC loss. Modification of preoperative age-related ECD thresholds is indicated to maintain an ECD that warrants safe future combined pIOL explantation and cataract surgery.

Implantation of Artisan toric phakic intraocular lens following Intacs in a patient with keratoconus

We report a 24-year-old man with bilateral keratoconus in whom Intacs (Addition Technology, Inc.) were implanted in both eyes. The procedure was followed by Artisan toric phakic intraocular lens (Ophtec) implantation to correct the residual myopic and astigmatic refractive error.

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.

The Influence of Incision-Induced Astigmatism and Axial Lens Position on the Correction of Myopic Astigmatism with the Artisan Toric Phakic Intraocular Lens

To evaluate postoperative astigmatism with regard to incision-induced astigmatism and deviation in axial alignment with the use of preoperative limbal marking with the Javal keratometer (Haag Streit, Bern, Switzerland) in eyes implanted with the Artisan toric phakic intraocular lens (IOL) (Ophtec, Groningen, The Netherlands). Prospective nonrandomized trial. Fifty-four eyes of 33 patients with myopia (mean, -9.67 diopters [D]) and astigmatism (mean, -3.44 D). The enclavation site was marked on the limbus using the Javal keratometer. The Artisan toric phakic IOL was implanted according to the axis marked on the limbus. Follow-up was a minimum of 6 months. Safety index, efficacy index, predictability, safety, and vector analysis of total refractive correction were determined. The effects of axis misalignment and incision-induced astigmatism on the final refractive error were evaluated. At 6 months after surgery, the safety index was 1.29+/-0.29 and the efficacy index was 1.04+/-0.35. Mean spherical equivalent subjective refraction reduced from -11.39+/-4.86 D before surgery to -0.38+/-0.57 D at 6 months. Sixty-seven percent of eyes were within 0.50 D of attempted refraction and 89% were within 1.00 D. Mean preoperative cylinder was 2.92+/-1.60 D at 91.4 degrees . At 6 months, the mean cylinder was 0.28+/-0.54 D at 174.3 degrees . No eyes lost 2 or more lines of best-corrected visual acuity at 6 months. Eighty-three percent of eyes achieved uncorrected visual acuity of 20/40 and 28% achieved 20/20. Vector analysis of total surgically induced astigmatism revealed a mean cylindrical change of 3.21+/-1.71 D. Average axis misalignment was 0.37+/-5.34 degrees . The mean incision-induced astigmatism was 0.74+/-0.61 D at 0.2 degrees . Implantation of the myopic toric IOL leads to safe, efficacious, and predictable results. The level of unpredictability caused by minor axis IOL misalignment has minimal effects on the residual refractive error. The procedure of axis alignment with the Javal keratometer seems to be an accurate method of marking the eye for toric IOL implantation. Incision-induced astigmatism can result in an overcorrection of the cylinder. A systematic undercorrection of -0.50 D for attempted cylindrical outcome could result in an achieved correction closer to emmetropia.

Toric phakic intraocular lens for the correction of hyperopia and astigmatism

To evaluate the Artisan toric phakic intraocular lens (pIOL) for the correction of hyperopia and astigmatism. Department of Ophthalmology, Erasmus MC, Rotterdam, The Netherlands, and Department of Ophthalmology, Sint Truiden, Belgium. 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. 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. 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.

Implantation of Artisan Toric Phakic Intraocular Lenses for the Correction of Astigmatism and Spherical Errors in Patients With Keratoconus

Implantation of Artisan Toric Phakic Intraocular Lenses for the Correction of Astigmatism and Spherical Errors in Patients With Keratoconus

Artisan Toric Phakic Intraocular Lens for Correction of Astigmatism

To assess the safety and efficacy of implanting Artisan toric phakic intraocular lenses (PIOLs) (Ophtec BV, Groningen, The Netherlands) in eyes with high degrees of compound myopic, hyperopic, and mixed astigmatism. Twenty-five eyes (20 patients) presenting with high astigmatism were implanted with Artisan toric PIOLs and followed for 1 year. Group 1 included 8 eyes (myopic astigmatism), group 2 included 9 eyes (hyperopic astigmatism), and group 3 included 8 eyes (mixed astigmatism). In the myopic astigmatism group, 8 (100%) of 8 eyes had preoperative uncorrected visual acuity (UCVA) of < or = 20/50, and at 6-month follow-up, 5 (62.5%) of 8 eyes had UCVA of > or = 20/40 (P = .005). In this group, 75% of eyes were within +/- 1.00 diopter (D) of the intended correction. In the hyperopic astigmatism group, 8 (88.9%) of 9 eyes had preoperative UCVA of < or = 20/40, and at 6-month follow-up, 6 (66.6%) of 9 eyes had UCVA of > or = 20/32 (P = .199). Approximately 77.8% of eyes were within +/- 1.00 D of the intended correction. In the mixed astigmatism group, 8 (100%) of 8 eyes had preoperative UCVA of < or = 20/50, and at 6-month follow-up, 6 (87.5%) of 8 eyes had UCVA of > or = 20/40 (P = .007). In this group, 87.5% of eyes were within +/- 1.00 D of the intended correction. The safety index of the procedure was 1.6, 1.3, and 1.3 in the myopic, hyperopic, and mixed astigmatism groups, respectively. The efficacy index of the procedure was 1.2, 1.0, and 1.0 in the myopic, hyperopic, and mixed astigmatism groups, respectively. Artisan toric PIOLs are safe for the correction of high degrees of astigmatism associated with myopic or hyperopic spherical refractive defect.

Implantation of Artisan Toric Phakic Intraocular Lenses for the Correction of Astigmatism and Spherical Errors in Patients With Keratoconus

To evaluate the correction of astigmatism and spherical ametropia in patients with keratoconus through implantation of an Artisan toric phakic intraocular lens (PIOL) (Ophtec, Groningen, The Netherlands). Artisan toric PIOLs were implanted uneventfully in both eyes of three patients with keratoconus with clear central corneas and contact lens intolerance. Best spectacle-corrected subjective visual acuity after lens implantation was unchanged in one eye and improved in five eyes. Spherical equivalent refraction was significantly reduced in all eyes (P=.03). The safety index was 1.49. The implantation of an Artisan toric PIOL may be an alternative for treating astigmatism and myopia in contact lens intolerant patients with keratoconus with clear central corneas. Especially in patients with associated myopia, this procedure is worth considering before planning a penetrating keratoplasty.

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.

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.

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.