Background: As part of the United States Food and Drug Administration Phase III clinical trial, patients were implanted with the STAAR posterior chamber phakic intraocular contact lens (ICL). The trial is designed to test the safety and efficacy of this new lens for the treatment of moderate-to-high myopia and hyperopia.
Methods: Data were collected from 20 hyperopes--mean preoperative spherical equivalent, +5.55 D, and 65 myopes-mean preoperative spherical equivalent, -8.42 D, who were implanted with ICLs in our clinic, from November 1998 to March 2000.
Results: Postoperatively, 40% of the hyperopic eyes were 20/20 or better without correction and 80% of the eyes 20/40 or better without correction, with a mean spherical equivalent of +0.06 D. One hyperopic lens was explanted and no adverse events were reported. Postoperatively, 52.31% of the myopic eyes were 20/20 or better without correction and 92.3% of the eyes were 20/40 or better without correction, with a mean spherical equivalent of -0.31 D. No lenses were explanted and one was treated for angle closure.
Conclusions: The STAAR Collamer ICL is a reasonably safe and effective procedure for the treatment of moderate-to-high refractive errors.