Endothelial Keratoplasty: Prospective, Randomized, Masked Clinical Trial Comparing an Injector With Forceps for Tissue Insertion

Abstract

In regard to the recent paper by Terry and associates, 1 Terry M.A. Straiko M.D. Goshe J.M. Shamie N. Shah A. Alqudah A.A. David-Boozer D. Endothelial keratoplasty: prospective, randomized, masked clinical trial comparing an injector with forceps for tissue insertion. Am J Ophthalmol. 2013; 156: 61-68 Abstract Full Text Full Text PDF PubMed Scopus (23) Google Scholar I would like to point out a potential mitigating factor that limits the clinical applicability of the paper. Although the authors state, “All other steps of the surgical procedure were exactly the same,” this is not precisely correct. The authors utilized viscoelastic protection for the Charlie II forceps (Bausch & Lomb Surgical, St. Louis, Missouri, USA) group and did not utilize any viscoelastic for the Neusidl Cornea Inserter (Fischer Surgical, Imperial, Missouri, USA) group, stating that viscoelastic is not part of the standard operating procedure for the Neusidl Cornea Inserter. The authors are confusing standard or typical use with what a manufacturer can list in its labeling. As the authors know, the Charlie forceps did not require any clinical data to support its marketing and, as such, the companies do not supply any use information or suggest the use of a viscoelastic. The procedure used by the authors is their standard of practice for the Charlie forceps and not a manufacture-supplied procedure. The Food and Drug Administration (FDA) required extensive clinical data from Fischer Surgical prior to their marketing of the Neusidl Cornea Inserter. The procedure the authors followed is not typical of the standard practice with the Neusidl Cornea Inserter, in which the majority of surgeons utilize viscoelastic. The original Neusidl Cornea Inserter standard operating procedure included the optional use of viscoelastic protection but that information was removed for the submission. The lack of viscoelastic use in the FDA protocol (personal communication) was based on limiting variables and potentially further data requests from the FDA as well as the belief that cell loss without viscoelastic would still be at an acceptable level. A proper or more comparative study would have used viscoelastic in both arms to better reflect the different insertion devices and techniques and would then have been more clinically meaningful. Endothelial Keratoplasty: Prospective, Randomized, Masked Clinical Trial Comparing an Injector With Forceps for Tissue InsertionAmerican Journal of OphthalmologyVol. 156Issue 1PreviewTo compare the complications and outcomes of Descemet stripping automated endothelial keratoplasty (DSAEK) when the tissue is either folded and inserted with a forceps or inserted using a platform injector device without folding. Full-Text PDF ReplyAmerican Journal of OphthalmologyVol. 156Issue 6PreviewI have been involved at every stage in the development of the Neusidl Corneal Inserter (NCI), from the moment that a talented ophthalmologist and innovative engineer, William Neusidl, showed me his initial drawings, through laboratory testing and revisions of several prototypes, to the clinical testing of the final product. Many surgeons who are uncomfortable with forceps or other insertion techniques have embraced the NCI, and it has allowed them to do safe Descemet stripping automated endothelial keratoplasty (DSAEK) surgery. Full-Text PDF