Clinical Performance and Surgeon Acceptability of a New Dual Mode Phacoemulsification System.

Purpose: The purpose of this first in-human study was to evaluate the overall clinical performance of the VERITAS™ Vision System in patients scheduled to undergo cataract extraction and to confirm overall surgeon acceptability. Patients and methods: This prospective, open-label multinational study included adults with cataracts scheduled for planned cataract extraction and posterior chamber IOL implantation. Standard small-incision phacoemulsification cataract surgery with the VERITAS Vision System was conducted. Surgeons completed a questionnaire regarding their clinical experience with the VERITAS Vision System for each patient following surgery and 1-day postoperative. Corneal clarity and adverse events (AEs) were assessed. Surgeon acceptability was scored on a 5-point scale, with acceptability considered favorable for scores of 4 and 5. Results: A total of 115 eyes (79 patients) were treated. The El Salvador site treated 41 patients (58 eyes), and the US site treated 38 patients (57 eyes). Overall, surgeons were satisfied with the clinical performance regardless of the cataract grade. The satisfaction with anterior chamber stability, post-occlusion surge, followability, holdability, cutting efficiency, usability, and overall satisfaction with the VERITAS Vision System was clinically favorable in ≥99% of cases. Overall satisfaction with the swivel handpiece, foot pedal, and enhanced ergonomics were clinically favorable in ≥97% of cases regardless of the cataract grade. Satisfaction with corneal clarity at same-day postoperative and 1-day postoperative, and 1-day overall clinical results of surgery with the VERITAS Vision System were clinically favorable in ≥94% of cases regardless of cataract grade. Conclusion: The new dual-mode phacoemulsification system with dual-durometer tubing, gas forced infusion, new swivel handpiece, and ergonomics improvements resulted in a high rate of user satisfaction with clinical performance and ergonomics. The VERITAS Vision System is safe and effective when used as indicated.

Evaluation of Intraocular Lens Rotational Stability in a Multicenter Clinical Trial.

PURPOSE: To evaluate the postoperative rotational stability of two prototype intraocular lens (IOL) designs (subsequently termed version 1 and version 2). PATIENTS AND METHODS: A prospective, multicenter, randomized, paired-eye, 6-month study evaluated the version 1 and version 2 IOLs. Results were compared with a control IOL (TECNIS® toric 1-piece monofocal IOL) evaluated in a separate, similarly designed study. Participants aged ≥22 years and scheduled to undergo bilateral cataract extraction were randomly assigned 1:1 to receive the version 1 or version 2 IOL in the first operative eye; the alternate test IOL was then implanted in the second operative eye. RESULTS: Mean absolute IOL rotation at postoperative week 1 was the primary effectiveness end point. Additional end points included the percentage of eyes with postoperative IOL rotation >5°/>10°, direction of lens rotation, surgeon-reported ease of IOL handling during implantation, and safety. At postoperative week 1, mean (±standard deviation) absolute IOL rotation was significantly lower for both version 1 and version 2 versus control (0.88° [±0.94] and 0.71° [±0.69] vs 2.24° [±3.21], respectively; both P < 0.001). For both study lenses, absolute rotation was <5° for all eyes at postoperative week 1, and no cases of rotation >10° were observed at any postoperative time point. From postoperative week 1 onward, version 2 had a statistically significant clockwise bias in the direction of rotation (P = 0.03); similar findings were observed for version 1. Surgeons reported acceptable ease of IOL handling during implantation for both version 1 and version 2. No device-related adverse events were reported. CONCLUSION: Both the version 1 and version 2 IOLs, each with frosted, squared haptics, demonstrated improved postoperative rotational stability compared with a control lens without frosted haptics. Because version 2 had the same overall geometry as the current TECNIS toric IOL, this design was selected for commercialization. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00015287.

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.

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.