Implantable contact lens for moderate to high myopia: phase 1 FDA clinical study with 6 month follow-up.

Abstract

PURPOSE:

To assess the short-term safety and efficacy of the implantable contact lens (ICL) to treat moderate to high myopia.

SETTING:

Phase 1 U.S. Food and Drug Administration clinical study of the ICL conducted at four sites in the United States.

METHODS:

Ten patients with myopia of 7.00 diopters (D) or greater had implantation of a Staar Surgical ICL and were examined preoperatively (baseline) and 1 day, 1 week, and 1, 3, and 6 months postoperatively. Mean preoperative myopia was 7.75 D (range 7.25 to 9.37 D).

RESULTS:

Six months postoperatively, 5 of 10 eyes (50%) had an uncorrected visual acuity (UCVA) of 20/20 or better, and all eyes had a UCVA of 20/30 or better. All eyes had a best spectacle-corrected visual acuity (BSCVA) of 20/20 or better and 6 eyes (60%), of 20/15 or better. Six eyes (60%) had an improvement of one or more lines of BSCVA. Mean postoperative spherical equivalent was -0.025 D +/- 0.47 (SD). Eight eyes (80%) were within +/- 0.250 D of emmetropia, and all were within +/- 1.125 D. No intraoperative or postoperative complications or adverse reactions were observed.

CONCLUSIONS:

The results support the short-term safety, efficacy, and predictability of ICL implantation to treat moderate to high myopia.

• Authors: D R Sanders, D C Brown, R G Martin, J Shepherd, M R Deitz, M DeLuca
• Journal: Journal of cataract and refractive surgery (J Cataract Refract Surg) Vol. 24 Issue 5 Pg. 607-11 (May 1998) ISSN: 0886-3350 [Print] United States
• PMID: 9610442 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article)

Topics

• Adult
• Contact Lenses
• Female
• Follow-Up Studies
• Humans
• Male
• Myopia (surgery)
• Prosthesis Implantation
• Safety
• Visual Acuity