Elsevier

Ophthalmology

Volume 115, Issue 3, March 2008, Pages 464-472.e1
Ophthalmology

Original article
Three-Year Results of Artisan/Verisyse Phakic Intraocular Lens Implantation: Results of the United States Food and Drug Administration Clinical Trial

Presented at: American Academy of Ophthalmology Annual Meeting, November 2003, Anaheim, California.
https://doi.org/10.1016/j.ophtha.2007.08.039Get rights and content

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.

Section snippets

Study Design and Subject Population

This was a prospective, open-label, noncomparative study sponsored by Ophtec USA (Boca Raton, FL), a subsidiary of Ophtec BV. The protocol was approved by the institutional review board at each study site. Study subjects were advised of the benefits and risks of lens implantation. Bilateral implantation was allowed after the first eye was stable, with no evidence of adverse events or loss of best spectacle-corrected visual acuity (BSCVA). A substudy was conducted at one site to evaluate

Enrollment

Subjects were recruited from October 1997 through July 2003 at 22 investigational sites by 35 investigators in the U.S. A total of 684 subjects were enrolled: 662 in the primary analysis group and 22 under compassionate use. The efficacy results are based on the 662 first eyes enrolled.

Table 1 shows the subject accountability. Of 662 subjects enrolled, 232 (35.0%) completed the 3-year follow-up, 357 of their cases (53.9%) are ongoing, and 73 of their cases (11.0%) were discontinued. Included in

Discussion

The results of this study indicate that the Verisyse phakic IOL corrects the refractive error in patients with high myopia with a high degree of predictability, long-term stability, and improvement in contrast sensitivity. Uncorrected distance VA was excellent, despite the fact that only 1.0-D lens power increments were available, patients with preoperative astigmatism were included, and postoperative refractive surgery was not allowed by the protocol. Adverse events were infrequent and

Acknowledgments

The authors thank Stan Bentow, PhD, for extensive statistical analysis of the data, and Kristen Featherstone, MS, and Debbie Trentacost, for essential contributions to the data analysis and compilation.

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    Manuscript no. 2006-1490.

    1

    Drs Stulting and John were Medical Monitors for the study.

    For Study Group members, see “Appendix 1” (available at http://aaojournal.org).

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