title: Toric phakic intraocular lens: European multicenter study.
abstract: 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.
  
  
  METHODS
  Prospective, nonrandomized, comparative (self-controlled) multicenter trial.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: Department of Ophthalmology, University of Mainz, Mainz, Germany. bdick@mail.uni-mainz.de
authors.forename: H Burkhard
authors.initials: HB
authors.lastname: Dick
authors.forename: Jorge
authors.initials: J
authors.lastname: Alió
authors.forename: Marco
authors.initials: M
authors.lastname: Bianchetti
authors.forename: Camille
authors.initials: C
authors.lastname: Budo
authors.forename: Bern Jurriën
authors.initials: BJ
authors.lastname: Christiaans
authors.forename: M Alaa
authors.initials: MA
authors.lastname: El-Danasoury
authors.forename: José L
authors.initials: JL
authors.lastname: Güell
authors.forename: Jörg
authors.initials: J
authors.lastname: Krumeich
authors.forename: Monika
authors.initials: M
authors.lastname: Landesz
authors.forename: Fransico
authors.initials: F
authors.lastname: Loureiro
authors.forename: Gregorius P M
authors.initials: GP
authors.lastname: Luyten
authors.forename: Antonio
authors.initials: A
authors.lastname: Marinho
authors.forename: Mohamed Saleh
authors.initials: MS
authors.lastname: Rahhal
authors.forename: Oliver
authors.initials: O
authors.lastname: Schwenn
authors.forename: Raimund
authors.initials: R
authors.lastname: Spirig
authors.forename: Urs
authors.initials: U
authors.lastname: Thomann
authors.forename: Jan
authors.initials: J
authors.lastname: Venter
mesh_terms: D000328:Adult; D001251:Astigmatism / Q000601:surgery*; D002452:Cell Count; D004728:Endothelium, Corneal / Q000166:cytology; D005260:Female; D006801:Humans; D006956:Hyperopia / Q000601:surgery*; D007429:Intraocular Pressure; D019654:Lens Implantation, Intraocular; D007908:Lens, Crystalline / Q000502:physiology*; D007910:Lenses, Intraocular; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000601:surgery*; D011183:Postoperative Complications; D011446:Prospective Studies; D012029:Refraction, Ocular; D012449:Safety; D014792:Visual Acuity