Posterior chamber phakic intraocular lens for hyperopia

PURPOSE: A Phase I U.S. FDA clinical study of a plate haptic posterior cham ber phakic intraocular lens (STAAR Surgical Implantable Contact Lens) for t reatment of hyperopia was conducted at 4 sites in the United States. The pu rpose of this report is to assess the short-term safety and efficacy. METHODS: Ten patients with hyperopia between +2.50 and +10.875 D were impla nted in one eye each with the posterior chamber plate phakic intraocular le ns and were examined at baseline and I day, 1 week, 1, 3, and 6 months afte r surgery. Mean baseline hyperopia was +6.63 D. RESULTS: At 6 months postoperatively, 7 of 10 eyes (70%) had an uncorrected visual acuity of 20/20 or better and 10 of 10 (100%) had 20/40 or better. Eight of ten eyes (80%) had a spectacle-corrected visual acuity within 1 li ne of baseline; the other two eyes (20%) had an improvement of 3 lines. Mea n B-month postoperative spherical equivalent refraction was +0.20 +/- 0.61D (range, -0.50 to +1.50 D), a reduction of 6.025 D from baseline. Eight of 10 eyes (80%) were within +/-0.50 D of emmetropia, 9 eyes (90%) were within +/-1.00 D, and all eyes (100%) were within +/-1.50 D. No operative or post operative complications or adverse reactions were observed. CONCLUSIONS: Results support the short-term safety, efficacy, and predictab ility of the STAAR Surgical Implantable Contact Lens (plate haptic posterio r chamber phakic intraocular lens) in the treatment of hyperopia.