Posterior chamber phakic intraocular lens for hyperopia.
OBJECTIVE
A Phase I U.S. FDA clinical study of a plate haptic posterior chamber phakic intraocular lens (STAAR Surgical Implantable Contact Lens) for treatment of hyperopia was conducted at 4 sites in the United States. The purpose 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 implanted in one eye each with the posterior chamber plate phakic intraocular lens and were examined at baseline and 1 day, 1 week, 1, 3, and 6 months after 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 line of baseline; the other two eyes (20%) had an improvement of 3 lines. Mean 6-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 postoperative complications or adverse reactions were observed.


CONCLUSIONS
Results support the short-term safety, efficacy, and predictability of the STAAR Surgical Implantable Contact Lens (plate haptic posterior chamber phakic intraocular lens) in the treatment of hyperopia.
Sanders
D R
DR
Center for Clinical Research, Chicago, IL, USA.
Martin
R G
RG
Brown
D C
DC
Shepherd
J
J
Deitz
M R
MR
DeLuca
M
M
D000328:Adult; D001672:Biocompatible Materials; D005500:Follow-Up Studies; D006801:Humans; D006956:Hyperopia / Q000601:surgery*; D019654:Lens Implantation, Intraocular; D007908:Lens, Crystalline; D007910:Lenses, Intraocular; D008689:Methacrylates; D008875:Middle Aged; D012029:Refraction, Ocular; D012449:Safety; D016896:Treatment Outcome; D014792:Visual Acuity
D001672:Biocompatible Materials; D008689:Methacrylates; C005044:hydroxyethyl methacrylate