Clinical outcomes of TECNIS toric intraocular lens implantation after cataract removal in patients with corneal astigmatism.

PURPOSE: To evaluate safety and effectiveness of the TECNIS toric intraocular lenses (IOLs). DESIGN: Prospective, multicenter, 2-armed, bilateral, 6-month clinical trial following the American National Standards Institute (ANSI) standard for Toric IOLs. PARTICIPANTS: Subjects implanted with a TECNIS toric IOL (n = 172) or a TECNIS 1-piece control IOL (ZCB00; n = 93). METHODS: Subjects underwent standard cataract surgery with IOL implantation. The randomized control arm consisted of subjects requiring cylinder correction of 0.75 to 1.50 diopters (D) who were implanted with either toric (ZCT150) or nontoric (ZCB00) IOLs. The open-label arm (OLA) consisted of subjects requiring cylinder correction of 1.50 to 3.62 D and implanted with ZCT225, ZCT300, or ZCT400 IOLs. MAIN OUTCOME MEASURES: Assessments were at 1 day, 1 week, and 1, 3, and 6 months and included uncorrected distance visual acuity (UCDVA) and best-corrected distance visual acuity (BCDVA), manifest refraction, keratometry, adverse events, spectacle use, and photographic documentation of IOL rotational stability. RESULTS: Mean percent reduction in cylinder (± standard deviation) was statistically significantly greater (P < 0.0001) for ZCT150 eyes (74.53 ± 72.25%) versus ZCB00 eyes (31.61 ± 78.73%). In the OLA, mean percent reduction in cylinder was 76.27 ± 33.09%. A UCDVA of 20/20 or better was achieved by 43.6% (44/101) of ZCT150 eyes and by 23.7% (22/93) of ZCB00 eyes (P = 0.0026). In the OLA, 38.0% (27/71) achieved 20/20 or better UCDVA. Mean UCDVA was 0.10 ± 0.14 for ZCT150 eyes and 0.16 ± 0.16 for ZCB00 eyes (P = 0.0009); in the OLA, mean UCDVA was 0.11 ± 0.12. The BCDVA was 20/40 or better for all eyes. Mean absolute lens rotation between visits for toric eyes pooled was less than 3°. Lens rotation of 5° or less occurred in 92.9% of toric eyes between 1 and 3 months and in 94.1% between 3 and 6 months, exceeding the ANSI standard for stability (≥ 90% of eyes with ≤ 5° of rotation between visits). Four lenses (2.3%) were repositioned during the study. CONCLUSIONS: The TECNIS toric IOLs successfully reduce ocular astigmatism and are a safe and effective treatment for cataract patients with corneal astigmatism.

Population-based visual acuity in the presence of defocus well predicted by classical theory.

According to classical theory, visual acuity (VA) can be modeled using the intersection of the eye's modulation transfer function with a retinal threshold function. To date, there have been limited attempts to validate this methodology by comparing theory with actual measured data. We use the methodology to predict the visual acuity in the presence of defocus of a population of cataract patients implanted with diffractive multifocal intraocular lenses. For the prediction, we used a set of physiological eye models that include chromatic and higher order aberrations. We found that the simulations correlated strongly to the clinical outcomes (R(2)=0.93). While the simulated VA of the eye models was systematically 0.05 logMAR units lower (better acuity) than the clinical results, this difference was independent of defocus (p=0.98). These results show that when the simple and straightforward classical theory is applied using physiological eye models, accurate predictions of the VA, and through-focus VA of a population can be made. This method may be suited for predicting visual performance of new cataract and refractive treatments.

Evaluation of the aspheric tecnis multifocal intraocular lens: one-year results from the first cohort of the food and drug administration clinical trial.

PURPOSE: To evaluate the safety and effectiveness of the aspheric diffractive Tecnis multifocal ZM900 (TCMF) intraocular lens (IOL; Abbott Medical Optics, Inc, Santa Ana, California, USA). DESIGN: One-year, nonrandomized, multicenter, evaluator-masked, bilateral, parallel-group comparative clinical evaluation. METHODS: Subjects underwent bilateral implantation with the TCMF IOL or the CeeOn 911A monofocal (CEMN) IOL (Abbott Medical Optics, Inc) according to subject preference. RESULTS: One-year results were available for 244 eyes of 125 TCMF IOL subjects and for 245 eyes of 123 CEMN IOL subjects. Mean distance visual acuities (VAs) were statistically and clinically equivalent between the 2 groups. Mean binocular and monocular uncorrected and distance-corrected near VAs were significantly better for the TCMF IOL versus the CEMN IOL group (P < .0001). A greater proportion of TCMF IOL versus CEMN IOL subjects achieved binocular combined VAs of 20/25 distance and 20/32 near (84.2% [96/114] vs 6.2% [7/113]; P < .0001). The TCMF IOL group had excellent depth of focus, maintaining a mean of 20/40 or better for far, intermediate, and near distances. Mean contrast sensitivity scores were lower for the TCMF IOL versus the CEMN IOL group, but the differences were not considered clinically significant. Halos and night glare were more common in the TCMF IOL versus the CEMN IOL groups. Both reading acuity (20/20 vs 20/47; P < .0007) and speed (148 vs 117 words/minute; P < .0001) were significantly better for the TCMF IOL versus the CEMN IOL group, as were the proportions of the TCMF IOL group versus the CEMN IOL group that achieved spectacle independence (84.8% vs 5.2%; P < .0001) and that functioned comfortably at near without glasses (96.4% vs 30.4%; P < .0001). CONCLUSIONS: The TCMF IOL provided enhanced near VA, reading acuity per speed, depth of focus, and spectacle independence compared with the monofocal IOL.