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VA De Groot, M-JJ Tassignon, GF J M Vrensen, Y Van Tenten; First Clinical Results of the Bag-in-the-lens Implantation Preventing PCO . Invest. Ophthalmol. Vis. Sci. 2002;43(13):2985.
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Purpose: To report on first clinical results of a new type of intraocular lens and implantation concept, called the "bag-in-the-lens" technique, in order to prevent posterior capsular opacification. Methods: Having performed a matched circular capsulorhexis in both the anterior and posterior capsule, the capsules are inserted in the flange of the intraocular lens, hence the term bag-in-the-lens technique in contrast with the currently used lens-in-the-bag technique. This new implant was implanted in an in vitro human capsular bag model and in 12 eyes of 10 patients with cataract. Lens epithelial cell (LEC) outgrowth and formation of secondary cataract were observed. Results: The in vitro capsular bag model showed LEC proliferation only within the space of the remaining lens bag, provided that both capsular blades were well stretched around the optical part of the rhexis implant. The LEC proliferation was very limited and there was no tendency of proliferation towards the visual axis. In all 12 eyes the optical axis remained clear during follow-up periods between 2 and 24 months. Even in a 4 year old child the visual axis was still perfectly clear after 2 years. Conclusion:This new IOL prevents LEC proliferation in vitro and seems very promising in vivo. Target patients are those at risk for secondary cataract formation, including congenital cataract, uveitis, diabetes or cataract combined with vitrectomy. A two year, multi-centre international trial is currently underway in 8 countries (Canada, Japan, Sweden, Spain, Germany, Israël, United Kingdom, Belgium).
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