Foldable Artiflex phakic intraocular lens for the correction of myopia: two-year follow-up results of a prospective European multicenter study.
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.


METHODS
Prospective, nonrandomized, open-label, multicenter trial.


METHODS
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.


METHODS
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.
Center for Vision Science, Ruhr University Eye Hospital, Bochum, Germany. burkhard.dick@kk-bochum.de
H Burkhard
HB
Dick
Camille
C
Budo
Francois
F
Malecaze
Josep L
JL
Güell
Antonio A P
AA
Marinho
Rudy M M A
RM
Nuijts
Gregorius P M
GP
Luyten
Jose L
JL
Menezo
Thomas
T
Kohnen
D000293:Adolescent; D000328:Adult; D002452:Cell Count; D004728:Endothelium, Corneal / Q000473:pathology; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007429:Intraocular Pressure; D007431:Intraoperative Complications; D007498:Iris / Q000601:surgery*; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D009216:Myopia / Q000503:physiopathology / Q000601:surgery*; D017060:Patient Satisfaction; D054120:Phakic Intraocular Lenses; D011183:Postoperative Complications; D011446:Prospective Studies; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology; D055815:Young Adult