Ergonomic Efficiency Field Evaluation of the C-03-35 Intraocular Lens Delivery System




Kajtoch, Michael


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Objective: The purpose of this post-market clinical investigation is to validate the ergonomic efficiency of the C-03-35 Intraocular Delivery System following cataract removal by phacoemulsification. The C-O-35 Delivery System is a newly approved device developed by Alcon Laboratories, Inc, which allows the delivery of the ACRYSOF Model SA60AS soft acrylic intraocular lens in a sterile, single-use and disposable unit that combines the hand piece plus the ACRYSOF intraocular lens-contained cartridge in an integrated system. This system is somewhat different from the predecessor MONARCH II Delivery System, which requires the surgeon to correctly insert the ACRYSOF intraocular lens into a cartridge and then assemble the cartridge into a reusable hand piece. The C-03-35 Delivery System eliminates these steps; therefore, it should decrease the risk of damage that may occur to the optic or the haptic as well as reducing surgery time. Materials and Methods: This study is an open label ergonomic assessment of the C-03-35 Delivery System that will be completed after the operative visit (performed on one eye only) of 120 patients by up to twelve investigators. The investigators will enroll patients requiring cataract extraction with intraocular lens implantation into the study that meet predetermined inclusion/exclusion criteria. Data Collection and Analysis: Upon concluding the surgical procedure, the investigator will complete a series of Case Report Forms consisting of questions assessing the ergonomic efficiency of the C-03-35 Delivery System. The Case Report Forms will comprise of questions regarding the optic and haptic placement, ease of use, as well as any adverse events that might have occurred. In addition, the investigator will complete an Exit Case Report Form once the patient concludes the study, is discontinued from the study, or if the patient fails to attend the follow-up visits. The required C-03-35 Case Report Form examination schedule is included in Appendix C. The information obtained from the Case Report Forms will then be entered into a clinical database. The safety information will be analyzed by the Biostatics Department by comparing the safety data obtained from the field evaluation to the Federal Food and Drug Administration’s standards called the FDA Grid of Historical Controls. The FDA Historical Grid provides pharmaceutical companies with performance guidelines by which the investigational test article is measured. In the case of intraocular lenses, the FDA Historical Grid provides standards for overall visual acuity (%20/40), best-case visual acuity (%20/40), and adverse events. Only adverse events will be compared to the FDA Historical Grid and analyzed for this field evaluation. The visual acuity parameters of the intraocular lens will not be analyzed in this study, since the C-03-35 Delivery System uses a FDA approved ACRYSOF Model SA60AS lens with established performance. In addition, the ergonomic efficiency questions such as ease of use will be summarized into a table. Although not currently on the protocol of the study, this information may also be further compared against the MONARCH II Delivery System analysis results, since safety as well as ergonomic efficiency data were also collected during that study. The FDA Grid of Historical Controls is included in Appendix D.