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

Simple item page
dc.contributor.advisorGwirtz, Patricia A.
dc.contributor.committeeMemberBens, Annita V.
dc.contributor.committeeMemberHileman, Kendra
dc.creatorKajtoch, Michael
dc.date.accessioned2019-08-22T21:27:17Z
dc.date.available2019-08-22T21:27:17Z
dc.date.issued2004-05-01
dc.date.submitted2014-02-24T07:00:05-08:00
dc.description.abstractObjective: 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.
dc.format.mimetypeapplication/pdf
dc.identifier.urihttps://hdl.handle.net/20.500.12503/29345
dc.language.isoen
dc.provenance.legacyDownloads0
dc.subjectEye Diseases
dc.subjectLaboratory and Basic Science Research
dc.subjectLife Sciences
dc.subjectMedicine and Health Sciences
dc.subjectOphthalmology
dc.subjectOptometry
dc.subjectSense Organs
dc.subjectSurgery
dc.subjectPost-market clinical investigation
dc.subjectergonomic efficiency
dc.subjectc-03035
dc.subjectintraocular delivery system
dc.subjectcataract removal
dc.subjectphacoemulsification
dc.subjectalcon laboratories
dc.subjectACRYSOF model sa60as
dc.subjectsoft acrylic intraocular lens
dc.subjectmonarch II delivery system
dc.subjectoperative visit
dc.subjecteye surgery
dc.subjectcase report forms
dc.titleErgonomic Efficiency Field Evaluation of the C-03-35 Intraocular Lens Delivery System
dc.typeThesis
dc.type.materialtext
thesis.degree.departmentGraduate School of Biomedical Sciences
thesis.degree.grantorUniversity of North Texas Health Science Center at Fort Worth
thesis.degree.nameMaster of Science

Files

Original bundle

Now showing 1 - 1 of 1
Thumbnail Image
Name:
Kajtoch_ErgonomicFieldEvaluationOf.pdf
Size:
21.36 MB
Format:
Adobe Portable Document Format
Download

Collections

School of Biomedical Sciences
Theses and Dissertations