Abstract
Purpose:
Assess visual acuity after implantation of either a standard TECNIS® (ZCB00) or a TECNIS® Toric (ZCT150) 1-piece intraocular lens (IOL).
Methods:
Multi-center, prospective, randomized, comparative, double-masked clinical investigation. Subjects underwent standard small-incision phacoemulsification cataract surgery followed by bilateral implantation of a ZCB00 or ZCT150 IOL. The ZCT150 is a 1-piece, hydrophobic-acrylic, aspheric, monofocal IOL. It is identical to the ZCB00 with the addition of 1.50 diopters (D) of cylinder power at the IOL plane. The lens is designed to correct corneal astigmatism from 0.75 D-1.50 D. At 6 months postoperative, uncorrected and best-corrected distance visual acuities (UCDVA, BCDVA), and manifest refraction were reported for the first eye implanted and a subject questionnaire was administered.
Results:
At 6 months (M) postoperative, the proportions of first eyes achieving UCDVA of 20/20 or better and 20/40 or better were statistically significantly higher for the toric lens group vs. the control (p=0.0026 and p=0.0092, respectively) with 43.6% (44/101) of ZCT150 eyes and 23.7% (22/93) of ZCB00 eyes achieving 20/20 or better, and 97.0% (98/101) of ZCT150 eyes and 87.1% (81/93) of ZCB00 eyes achieving 20/40 or better. Mean UCDVA for toric eyes was also statistically significantly higher (p=0.0009) for ZCT150 eyes (LogMAR 0.16 ± 0.16 (mean ± SD)) compared to control eyes (LogMAR 0.10 ± 0.14). BCDVA was 20/40 or better for all eyes. 72.3% (73/101) of ZCT150 eyes and 49.5% (45/93) of ZCB00 eyes were within 0.5 D of target and 94.1% (95/101) of ZCT150 eyes and 70.3% (64/93) of ZCB00 eyes were within 1.0 D of refractive cylinder target. The mean percent reduction in cylinder from preoperative to 6 M postoperative was 74.53% ± 72.25 for the ZCT150 eyes and 31.61% ± 78.73 for the ZCB00 eyes (p<0.0001). More ZCT150 subjects (83.6%) compared to control subjects (70.8%) never wore glasses for distance. Toric subjects had less difficulty than control subjects watching TV or movies, driving at night, driving when it is raining, or driving with glare from oncoming headlights.
Conclusions:
These results indicate the TECNIS® Toric IOL is an effective tool to improve visual acuity and reduce refractive cylinder over standard monofocal IOLs in patients with 0.75 D-1.50 D of corneal astigmatism.
Keywords: 428 astigmatism •
567 intraocular lens •
462 clinical (human) or epidemiologic studies: outcomes/complications