Toric Implantable Collamer Lens for high myopic astigmatic Asian eyes.

PURPOSE: To evaluate early visual outcomes, refractive outcomes, and complications of the Toric Implantable Collamer Lens (TICL) for the correction of high myopic astigmatism in Asian eyes.

DESIGN

Prospective, nonrandomized clinical study.

PARTICIPANTS

Forty-four eyes of 29 patients with myopia (spherical equivalent) between 6 and 18.25 diopters (D), and 1 and 4.5 D of astigmatism.

METHODS

Implantation of TICL.

MAIN OUTCOME MEASURES: Uncorrected visual acuity (UCVA), manifest refraction, best spectacle-corrected visual acuity (BSCVA), and postoperative complications.

RESULTS

At 6 months postoperatively, 70.59% of eyes had 20/20 or better UCVA and 68.57% had postoperative UCVA better than or equal to preoperative BSCVA. At baseline, no eyes had refractive cylinder <1 D; however, postoperatively 77.14% of eyes had <1.00 D of refractive cylinder. The mean refractive cylinder changed from 2.64 D (+/-0.91) preoperatively to 0.59 D (+/-0.51) postoperatively. Sixty percent of eyes were within 0.50 D and 85.71% of eyes were within 1.00 D of the targeted cylinder correction. Baseline manifest refraction spherical equivalent (MRSE) changed from -13.18 D (+/-2.41) to 0.00 D (+/-0.42) postoperatively. The number of eyes within 0.50 D and 1.00 D of the predicted MRSE were 82.86% and 97.14%, respectively. A BSCVA of 20/15 occurred in 45.71% of eyes postoperatively compared with 22.86% of eyes preoperatively. A BSCVA of 20/20 or better occurred in 94.29% postoperatively compared with 77.14% preoperatively. Postoperatively, 1 eye (2.86%) lost 1 line of BSCVA and none lost >1 line of BSCVA. Thirty-one percent of eyes gained 1 line of BSCVA and 8.57% gained 2 lines of BSCVA postoperatively. Misalignment of TICL axis occurred in 2 eyes of 2 patients.

CONCLUSIONS

The visual outcomes, refractive outcomes, and predictability are comparable with the United States Food and Drug Administration data on TICLs in non-Asian eyes. Safety concerns were not identified.