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Daniel Chang, Elizabeth Davis; Multicenter clinical evaluation of an aspheric diffractive multifocal one-piece IOL. Invest. Ophthalmol. Vis. Sci. 2013;54(15):833.
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To evaluate clinical outcomes, patient satisfaction, and surgeon satisfaction following bilateral implantation of the TECNIS® Multifocal 1-Piece IOL (ZMB00).
On-going, prospective, open-label observational trial from surgeons performing cataract surgery and bilateral TECNIS® Multifocal (TMF) 1-Piece IOL implantation in qualified subjects aged 21 years or older. All eyes had preoperative corneal astigmatism of < 1.0 D. Visual acuity (distance, intermediate, near) and patient satisfaction questionnaires were collected at the 3-4 month postoperative visit. Surgeon assessment questionnaires were taken at 3 months and at one year.
Interim data were collected on 106 subjects with a mean age of 66.0 ± 8.1 years. Mean postoperative sphere was 0.07 ± 0.47 D with 0.40 ± 0.39 D of cylinder and a spherical equivalent of +0.05 ± 0.47 D. Mean binocular UCVA was 20/23 at distance, 20/30 at intermediate and 20/22 at near. Mean binocular DCVA was 20/20 at distance, 20/28 at intermediate, and 20/21 at near. The percentage of subjects with UCVAs of 20/32 or better was 91.8% for distance, 67.7% for intermediate, and 93.8% for near. The percentage of subjects with DCVAs of 20/32 or better was 98.8% for distance, 70.9% for intermediate, and 96.6% for near. At 3-4 months postoperative, 86.9% of subjects never or hardly ever use glasses, 87.9% of subjects were either satisfied or very satisfied with their overall vision without glasses, and 81.3% of subjects would most likely choose this lens again. At the 3 months, 78.5% of surgeons felt comfortable with the TMF after implanting ≤ 6 lenses, and 92.9% of surgeons would recommend the TMF to family, friends, and colleagues. At one year, 86% of top enrollers were still using the TMF.
Subjects receiving the TECNIS® Multifocal 1-Piece IOL showed high levels of satisfaction with good visual outcomes at all distances and minimal postoperative refractive error. Surgeon-reported experience and perception of the TMF were highly positive. This experiential data further corroborates the U.S. FDA clinical study results.
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