John Chang1, Silvania Lau. 1. The Guy Hugh Chan Refractive Surgery Centre, Department of Ophthalmology, Hong Kong Sanatorium and Hospital, Hong Kong.
Abstract
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.
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.