Original articleThree-Year Results of Artisan/Verisyse Phakic Intraocular Lens Implantation: Results of the United States Food and Drug Administration Clinical Trial
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.
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Drs Stulting and John were Medical Monitors for the study.
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For Study Group members, see “Appendix 1” (available at http://aaojournal.org).