Preloaded injectors used in a clinical study: videographic assessment and laboratory analysis of injector-nozzle damage.

Abstract

PURPOSE\nTo evaluate quality and duration of implantation of two preloaded intraocular lens (IOL) injectors and assess post-implantation damage.\n\n\nDESIGN\nProspective, randomized, comparative study with laboratory investigation.\n\n\nSETTING\nThe David J Apple Center for Vision Research, Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany.\n\n\nMETHODS\nImplantation videos and post-use injectors from 60 paired-eyes of 30 bilateral cataract patients were included. Patients eyes were randomly assigned for implantation with two different preloaded injectors: the AutonoMe with a Clareon IOL (Alcon, Fort Worth, USA) and the iSert with a Vivinex IOL (Hoya, Tokyo, Japan). Videos were reviewed for events during the implantation procedure and the duration of each step of implantation. Injectors nozzles were examined under light and scanning electron microscopy. Damage was graded and correlated with the IOL power. Three-months postoperatively, IOLs were assessed for material changes.\n\n\nRESULTS\nIOL delivery was without any critical events. The implantation took 56 seconds with the AutonoMe and 44 seconds with the iSert, P < 0.05. The majority of AutonoMe injectors (97 %) showed no damage or slight deformation. In most of the iSert injectors (80 %) short or extended cracks were present, and damage lengths correlated with the IOL power. All IOLs were free of material changes, including glistenings, 3 months after surgery.\n\n\nCONCLUSIONS\nBoth preloaded IOL injectors allowed a safe and convenient IOL delivery. Implantation of the Clareon took on average slightly longer than the Vivinex, mostly due to a slower IOL unfolding. The AutonoMe showed less nozzle tip damage than the iSert.