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Volume 116, Issue 4, Pages 671-677 (April 2009)


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Foldable Artiflex Phakic Intraocular Lens for the Correction of Myopia: Two-Year Follow-up Results of a Prospective European Multicenter Study

Presented at: American Academy of Ophthalmology Annual Meeting, October 2005, Chicago, Illinois.

H. Burkhard Dick, MD1Corresponding Author Informationemail address, Camille Budo, MD2, Francois Malecaze, MD3, Josep L. Güell, MD4, Antonio A.P. Marinho, MD5, Rudy M.M.A. Nuijts, MD6, Gregorius P.M. Luyten, MD7, Jose L. Menezo, MD8, Thomas Kohnen, MD9

Received 22 March 2008; received in revised form 22 December 2008; accepted 22 December 2008.

Objective

To evaluate the safety, efficacy, predictability, stability, and complications of the foldable Artiflex iris-fixated intraocular lens (Ophtec BV, Groningen, The Netherlands) for the correction of myopia in phakic eyes.

Design

Prospective, nonrandomized, open-label, multicenter trial.

Participants

Two hundred ninety eyes of 191 patients aged 18 to 60 years with average spherical equivalent of –7.33±2.60 diopters (D; range, –12.63 to –1.5 D) were analyzed.

Methods

All eyes underwent implantation of the foldable iris-fixated Artiflex phakic intraocular lens (PIOL) with an optic zone of 6 mm. The follow-up was 2 years. Phakic intraocular lenses were implanted in powers ranging from –2.0 to –12.0 D.

Main Outcome Measures

The main parameters assessed were best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity (UCVA), refraction, and endothelial cell count.

Results

After 2 years, a UCVA of 20/40 or better was observed in 97.2% of eyes. The BSCVA was 20/40 or better in all eyes. A gain of 1 line or more of BSCVA was found in 49.9% of eyes, and 0.8% lost 2 or more lines. The mean endothelial cell change was –0.05%, 1.79%, and –1.07% at 6 months, 1 year, and 2 years, respectively. Complications were comparable with complications that have been reported previously of the Artisan PIOL, the only exception being a higher incidence of iris pigment precipitates (4.8% at 2 years after surgery).

Conclusions

After 2 years of follow-up, the implantation of the foldable iris-fixated Artiflex intraocular lens proved to be effective and predictable for the correction of myopia in phakic eyes.

Financial Disclosure(s)

The author(s) have no proprietary or commercial interest in any materials discussed in this article.

1 Center for Vision Science, Ruhr University Eye Hospital, Bochum, Germany

2 Department of Ophthalmology, Sint-Truiden, Belgium

3 Department of Ophthalmology, Hopital de Toulouse, Toulouse, France

4 Instituto de Microcirugia Ocular IMO, Barcelona, Spain

5 Clinica Oftalmologica, Porto, Portugal

6 Academisch Ziekenhuis, Maastricht, The Netherlands

7 Rotterdam Eye Hospital, Rotterdam, The Netherlands

8 Hospital Universitario “La Fe,” Departamento de Ofthalmologica, Valencia, Spain

9 Department of Ophthalmology, University Eye Hospital, Frankfurt, Germany

Corresponding Author InformationCorrespondence: H. Burkhard Dick, MD, Center for Vision Science, Ruhr University Eye Hospital, In der Schornau 23-25, 44892 Bochum, Germany

 Manuscript no. 2008-375.

 Study Group: Netherlands: J. G. F. Worst, B. Christiaans, M. Luger, M. Landesz, G. P. M. Luyten, R. Nuijts; Belgium: C. Budo, H. Termote; France: F. Malecaze, E. Hachet; Germany: H. B. Dick, T. Kohnen; Greece: G. Georgariou; Portugal: A. Marinho, F. Loureiro; Saudi Arabia: M. A. El Danasoury; Slowakia: M. Izak; South Africa: F. Potgieter, J. Venter; Spain: J. L. Guell, J. Menezo; Switzerland: R. Spirig; Tunesia: S. Mahjoub.

 Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

 Supported by an unrestricted grant from Ophtec, Groningen, The Netherlands.

PII: S0161-6420(08)01359-6

doi:10.1016/j.ophtha.2008.12.059


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