Iris-supported Phakic Lenses (Rigid vs Foldable Version) for Treating Moderately High Myopia: Randomized Paired Eye Comparison
Accepted 25 July 2006. published online 30 August 2006.
Purpose
To compare refractive performance of Artisan (Ophtec, Groningen, The Netherlands) or Verisyse phakic intraocular lens and its foldable version, Artiflex (Ophtec), for the correction of moderately high myopia.
Design
Randomized pilot study.
Methods
setting: Institutional practice. patient population: Thirty-one patients with myopia that ranged from −6 to −14 diopters (D). interventional procedure: One eye was implanted with an Artisan phakic intraocular lens (PIOL) and the other with an Artiflex PIOLs. main outcome measures: Primary outcome measure was the percentage of eyes with uncorrected visual acuity (UCVA) of >20/40 at one year after the operation. Main secondary outcome measures were the safety index, the change of two lines or more of best spectacle-corrected visual acuity (BSCVA) and the endothelial cell count.
Results
No intraoperative complications were noticed. One year after surgery, the percentage of eyes with UCVA of >20/40 was 51.6% (16/31 patients) for Artisan-treated eyes and 77.4% (24/31 patients) for Artiflex-treated eyes (P = .033). One month after surgery, this same percentage was 42.9% (13/31 patients) and 77.4% (24/31 patients), respectively (P = .004). The safety index at one year was 1.13 ± 0.24 for Artisan-treated eyes and 1.12 ± 0.21 for Artiflex-treated eyes, which is a difference that was not statistically significant (P = 0.742). At one year after surgery, the changes of two lines or more of BSCVA and the endothelial cell loss were similar for both groups.
Conclusion
To correct moderately high myopia, the Artiflex lens provides a faster visual recovery and a better UCVA than does the Artisan lens. The safety of the lens should be supported by an enlarged sample size and a longer follow-up period.
aOphthalmology Department, Purpan Hospital, Toulouse, France
bInstituto de Microcirugìa Ocular, Barcelona, Spain
cInstitut National de la Santé Et de la Recherche Médicale, Toulouse, France.
Inquiries to François Malecaze, MD, PhD, Ophthalmology Department, Purpan Hospital, Place Dr Baylac, 31059 Toulouse Cedex, France
ABSTRACT