Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food And Drug Administration clinical trial.
OBJECTIVE
To assess the safety and efficacy of the Artisan/Verisyse phakic intraocular lens (IOL) for the correction of high myopia.


METHODS
Prospective, open-label, noncomparative, multicenter clinical trial.


METHODS
A total of 684 adults with axial myopia from -4.5 diopters (D) to -22 D were enrolled: 662 in the primary analysis group and 22 under compassionate use protocol expansion. Efficacy data are based on the 662 first eyes implanted.


METHODS
Implantation of the Artisan/Verisyse phakic intraocular lens.


METHODS
Efficacy measures included uncorrected distance visual acuity (UCVA), refractive predictability and stability, patient satisfaction, and contrast sensitivity. Safety measures were best spectacle-corrected visual acuity (BSCVA), intraocular pressure, slit-lamp observations, endothelial cell density (ECD), complications, and adverse events.


RESULTS
At 3 years, UCVAs for first eyes were 20/40 or better in 84.0% (194/231) and 20/25 or better in 51.9% (120/231). Of first eyes, 71.7% to 76.7% were within 0.50 D of target refraction and 93.1% to 95.0% were within 1.0 D at 6 months and later. Best spectacle-corrected visual acuity was 20/40 or better for 99% to 100% of first eyes from the 1-month visit through 3 years. At 3 years, 54% of first eyes gained >/=1 lines of BSCVA, and 7.5% lost >/=1 lines of BSCVA. The mean change in ECD from baseline to 3 years was -4.8%+/-7.8%, with a 2.4% loss between 2 and 3 years. One site had a mean cell loss of -5.0% (P = 0.023), and the others combined had a mean cell loss of 1.7%+/-5.4%. For a cohort of 57 eyes with ECD data for all visits, the mean change from baseline was -3.8%+/-9.8% over 3 years. Approximately half (31/59) of the adverse events and preventative repositionings were among the first 10 cases performed by each investigator.


CONCLUSIONS
The Artisan/Verisyse phakic IOL provides excellent refractive outcomes; endothelial cell loss within a mean of 5.0% over 3 years, or 1.8% per year; and few complications.
Stulting
R Doyle
RD
Department of Ophthalmology, Emory University, Atlanta, Georgia 30342, USA. ophtrds@emory.edu
John
Maurice E
ME
Maloney
Robert K
RK
Assil
Kerry K
KK
Arrowsmith
Peter N
PN
Thompson
Vance M
VM
D000328:Adult; D002452:Cell Count; D015350:Contrast Sensitivity / Q000502:physiology; D004728:Endothelium, Corneal / Q000473:pathology; D005260:Female; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D007431:Intraoperative Complications; D019654:Lens Implantation, Intraocular; D008297:Male; D009216:Myopia / Q000503:physiopathology / Q000601:surgery*; D054120:Phakic Intraocular Lenses; D011183:Postoperative Complications; D011446:Prospective Studies; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration; D014792:Visual Acuity / Q000502:physiology