In vivo evaluation of the incision size and in vitro evaluation of the injector damage in two preloaded IOL delivery devices
First Author: R.Khoramnia GERMANY
Co Author(s): T. Yildirim M. Dzhambazova-Baev J. Weidler T. Naujokaitis S. Schickhardt G. Auffarth
The aim of the study is to compare the incision enlargement and cartridge damage after the use of two preloaded IOL delivery devices, Clareon AutonoMe (Alcon) and Vivinex iSert (Hoya), intraindividually in patients undergoing cataract surgery
The David J Apple International Laboratory for Ocular Pathology, University of Heidelberg, Heidelberg, Germany.
56 eyes (28 patients) without any other relevant ocular pathology are included in this prospective, bilateral, paired-eye, randomized, comparative clinical trial. The incision sizes before and after the implantation are measured with a caliper. The time needed for IOL implantation, insertion, unfolding and centration are measured using videos of the surgery. The tips of all used injectors are assessed in the laboratory (light and scanning electron microscopy) to check for potential damages (e.g. slight scratches, deep scratches, extensions, cracks, bursts). Visual acuities, refractive predictability and glistenings are evaluated 3 months after surgery.
The wound stretch was 0.21±0.11 mm in the eyes treated with the AutonoMe injector and 0.29±0.10 mm in the eyes treated with the iSert injector. Light and scanning electron microscopy of the injector tips showed so far the following results: 1.) AutonoMe: 78% no damage, 22% slight scratches. 2.) iSert: 12% slight scratches, 13 % deep scratches, 38% slight cracks, 6% extensions, 31% cracks and bursts.
The AutonoMe injector causes less wound stretch of the incision site after the IOL implantation than its counterpart iSERT. Light and scanning electron microscopy of the tip of the AutonoMe injector showed less damage than the iSERT injector. The time needed for the implantation was comparable in both lenses. Complication and adverse event rates were also within those given ISO standards for posterior chamber IOL.
receives non-monetary benefits from a company producing, developing or supplying the product or procedure presented, travel has been funded, fully or partially, by a competing company, travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a competing company, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives non-monetary benefits from a competing company