Implantable contact lens for moderate to high myopia: phase 1 FDA clinical study with 6 month follow-up.
OBJECTIVE
To assess the short-term safety and efficacy of the implantable contact lens (ICL) to treat moderate to high myopia.


METHODS
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.
Sanders
D R
DR
Center for Clinical Research, Elmhurst, Illinois 60126, USA.
Brown
D C
DC
Martin
R G
RG
Shepherd
J
J
Deitz
M R
MR
DeLuca
M
M
D000328:Adult; D003261:Contact Lenses; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009216:Myopia / Q000601:surgery*; D019919:Prosthesis Implantation; D012449:Safety; D014792:Visual Acuity