Three-year results of Artisan/Verisyse phakic intraocular lens implantation. Results of the United States Food And Drug Administration clinical trial.

Abstract

OBJECTIVE:

To assess the safety and efficacy of the Artisan/Verisyse phakic intraocular lens (IOL) for the correction of high myopia.

DESIGN:

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

PARTICIPANTS:

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.

INTERVENTION:

Implantation of the Artisan/Verisyse phakic intraocular lens.

MAIN OUTCOME MEASURES:

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.

• Authors: R Doyle Stulting, Maurice E John, Robert K Maloney, Kerry K Assil, Peter N Arrowsmith, Vance M Thompson, U.S. Verisyse Study Group
• Journal: Ophthalmology (Ophthalmology) Vol. 115 Issue 3 Pg. 464-472.e1 (Mar 2008) ISSN: 1549-4713 [Electronic] United States
• PMID: 18031820 (Publication Type: Controlled Clinical Trial, Journal Article, Multicenter Study)

Topics

• Adult
• Cell Count
• Contrast Sensitivity (physiology)
• Endothelium, Corneal (pathology)
• Female
• Humans
• Intraocular Pressure (physiology)
• Intraoperative Complications
• Lens Implantation, Intraocular
• Male
• Myopia (physiopathology, surgery)
• Phakic Intraocular Lenses
• Postoperative Complications
• Prospective Studies
• Treatment Outcome
• United States
• United States Food and Drug Administration
• Visual Acuity (physiology)