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Approved in the European Union in June 2015, the UltraSert™ Delivery System will be launched in Europe following ESCRS
Barcelona, Spain, September 5, 2015 – Alcon, the global leader in eye care and a division of Novartis, unveiled new pre-clinical data on the UltraSert™ Delivery System pre-loaded with AcrySof® IQ IOL, showing that the system created the least corneal incision enlargement and lowest final incision size versus two commonly used preloaded injectors.
The data was presented at the XXXIII European Society of Cataract and Refractive Surgeons Congress (ESCRS) in Barcelona, Spain, on September 5th-9th, 2015. Approved in the European Union in June 2015, the UltraSert preloaded IOL delivery system combines the control of a manually-loaded device with the convenience of a disposable, pre-loaded injector. The system is designed to optimize implantation of the AcrySof® IQ IOL during cataract surgery.
In a pre-clinical study of ex-vivo porcine eyes conducted by Alcon Research Ltd. it was demonstrated that the UltraSert™ Pre-loaded IOL Delivery System could successfully place the IOL in the capsular bag, without requiring any further additional surgical manipulation, while demonstrating a low corneal incision enlargement and a low final incision size.1,2
Study details:
In the first part of the study, freshly-excised porcine eyes were randomly assigned to two study groups (N=10 per group) consisting of the UltraSert™ Delivery System and Alcon’s commonly used manual IOL delivery system Monarch® III delivering a 21.0D IOL into the capsular bag. IOL delivery parameters were assessed by a single surgeon by measuring pre/post-delivery corneal incision size, rate of successful in-the-bag IOL delivery, and other IOL/delivery system parameters. Although the UltraSert™ Delivery System and Monarch® III delivery system had different initial corneal incision size (knife size of 2.2mm and 2.4mm, respectively), the UltraSert™ showed similar performance and comparable corneal wound enlargement of 0.07 ± 0.05mm.2
In the second part of the study, freshly-excised porcine eyes were randomly assigned to four study groups (N=10 per group) consisting of UltraSert™ delivery system (2.2mm incision), iSert^ (2.2mm incision), and iTec^ (2.2mm and 2.4mm incisions) delivering a 21.0D IOL in the capsular bag. IOL delivery parameters were assessed by a single surgeon by measuring pre/post-delivery corneal incision size, rate of successful in-the-bag IOL delivery, and other IOL/delivery system parameters. All delivery systems evaluated successfully placed the IOL in the capsular bag, but with a 2.2mm incision size, the UltraSert™ delivery system had a lower final incision size (2.31 ±0.06mm) than iSert^ and iTec^ (p<0.05).1
‘We developed the UltraSert™ Pre-loaded Delivery System based on important feedback from our surgeon partners who require controlled delivery of the IOL in a pre-loaded delivery system while maintaining the incision architecture. We are pleased these recent pre-clinical studies show smooth, consistent delivery of the AcrySof® IQ IOL, and provide a minimally invasive incision for surgeons and patients,” said Franck Leveiller, Alcon Surgical Head of Research & Development.
The pre-clinical data on the UltraSert™ Delivery System were presented during the ESCRS congress in Barcelona, Spain:
Important Information about the UltraSert™ Pre-loaded Delivery System
As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include corneal endothelial damage, endophthalmitis, retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon, and transient or persistent glaucoma. Only Alcon qualified viscoelastic(s) should be used with the UltraSert™ Pre-loaded Delivery System. The use of an unqualified viscoelastic may cause damage to the lens and potential complications during the implantation process.
