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




In regard to the recent paper by Terry and associates, 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.

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Jan 9, 2017 | Posted by in OPHTHALMOLOGY | Comments Off on Endothelial Keratoplasty: Prospective, Randomized, Masked Clinical Trial Comparing an Injector With Forceps for Tissue Insertion

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