Posterior chamber phakic intraocular lens for hyperopia.

Abstract

PURPOSE:

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.

• Authors: D R Sanders, R G Martin, D C Brown, J Shepherd, M R Deitz, M DeLuca
• Journal: Journal of refractive surgery (Thorofare, N.J. : 1995) (J Refract Surg) 1999 May-Jun Vol. 15 Issue 3 Pg. 309-15 ISSN: 1081-597X [Print] United States
• PMID: 10367572 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article, Multicenter Study)

Chemical References

• Biocompatible Materials
• Methacrylates
• hydroxyethyl methacrylate

Topics

• Adult
• Biocompatible Materials
• Follow-Up Studies
• Humans
• Hyperopia (surgery)
• Lens Implantation, Intraocular
• Lens, Crystalline
• Lenses, Intraocular
• Methacrylates
• Middle Aged
• Refraction, Ocular
• Safety
• Treatment Outcome
• Visual Acuity