Staar Collamer intraocular lens: clinical results from the phase I FDA core study

J Cataract Refract Surg. 1998 Aug;24(8):1032-8. doi: 10.1016/s0886-3350(98)80095-3.

Abstract

Purpose: To assess the early postoperative efficacy and safety of the Staar Collamer intraocular lens (IOL) in small incision cataract surgery.

Setting: Six private ophthalmology practices geographically distributed throughout the United States.

Methods: One hundred twenty-five patients with a mean age of 72.1 years were enrolled in the U.S. Food and Drug Administration (FDA) Phase 1 clinical study of the Staar Collamer IOL after having cataract removal by phacoemulsification. Of these, 107 completed 4 to 6 months of follow-up.

Results: At 4 to 6 months postoperatively, 97.1% of patients achieved 20/40 or better corrected visual acuity; 100% of patients without pre-existing pathology (best case) achieved the same result; both results were better than FDA grid values. No persistent sight-threatening complications were reported. Through 6 months, 4.7% of patients required a neodymium:YAG capsulotomy. No IOL dislocations or removals were reported.

Conclusion: Results indicate that the Collamer material is safe and effective for platehaptic IOLs used in small incision cataract surgery.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cornea / surgery
  • Female
  • Follow-Up Studies
  • Humans
  • Lens Implantation, Intraocular*
  • Lenses, Intraocular*
  • Male
  • Middle Aged
  • Phacoemulsification
  • Polyhydroxyethyl Methacrylate
  • Safety
  • Suture Techniques
  • Treatment Outcome
  • United States
  • United States Food and Drug Administration
  • Visual Acuity

Substances

  • Polyhydroxyethyl Methacrylate