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Steven Anderson, Lucas Feuchter, Roland Pohl, Michael Amon, Oliver Findl, Gandolf Sauder; Performance of a new preloaded insertion system for a 1-piece hydrophobic-acrylic, aspheric intraocular lens. Invest. Ophthalmol. Vis. Sci. 2013;54(15):1846.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate clinical acceptability and handleability of the TECNIS iTec preloaded insertion system (iTec) for implantation of the TECNIS® 1-piece hydrophobic-acrylic, aspheric intraocular lens (Model ZCB00).
Prospective, open-label, non-comparative, case series across three (3) surgical sites. The iTec is designed for the storage and delivery of TECNIS® 1-piece IOLs, through a 2.2 mm to 2.4 mm incision, following small-incision cataract surgery. Three surgeons at 3 different sites assessed the inserter on a scale of 1=poor/difficult, 2=fair, 3=average, 4=good, 5=excellent/easy.
The insertion system was used in 24 cataract surgery cases. There were no inserter-related complications during lens implantation. The mean overall score for satisfaction with the iTec was 4.5 (excellent). Investigators reported that filling the device with viscoelastic, depressing the plunger to fold the IOL, and placing the IOL in the bag were all easy (mean score 5.0 for each). Torque required to advance IOL through the tube and IOL delivery speed were good (4.3 for both). Length of time for IOL unfolding, overall surgeon control during delivery, and overall ease of use were also rated excellent (5.0, 4.7, and 4.7). All surgeons reported that the IOL was in excellent condition after implantation, with no scratching or debris residue on the lens. Convenience in comparison to non- preloaded systems and the impact of the device on OR efficiency was good to excellent (3.7 and 4.7, respectively). Other benefits of the system noted by the investigators were not having to resterilize the inserter, and the inserter could be used successfully through a 2.2 mm incision.
The TECNIS iTec preloaded insertion system provided good to excellent handleability and surgeon acceptability for planar insertion of the TECNIS® 1-piece IOL into the capsular bag of the eye after phacoemulsification cataract surgery.
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