Posters

In vivo evaluation of the incision size of Clareon injector AutonoMe Preloaded and Vivinex with the iSERT injector

Poster Details

First Author: R.Khoramnia GERMANY

Co Author(s):    W. Jan   H. Fang   S. Schickhardt   I. Baur   G. Auffarth        

Abstract Details

Purpose:

The aim of the study is to compare the incision enlargement and cartridge damage after implantation of two preloaded devices, Clareon AutonoMe (Alcon) and Vivinex iSert (Hoya), intraindividually in patients after cataract surgery. Additionally, we evaluate whether there is correlation between the damage of the cartridge nozzle tip and incision engagement or other parameters such as implantation time, complications and visual acuity.

Setting:

The David J. Apple International Laboratory for Ocular Pathology - Department of Ophthalmology, University of Heidelberg, Germany

Methods:

68 eyes (34 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 the Osher 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.

Results:

The preliminary evaluation in this ongoing trial showed a wound stretch of 0.29±0.03 mm (from 2.20±0.00 mm pre implantation to 2.49±0.03 mm post implantation) in the eyes treated with the AutonoMe injector and a wound stretch of 0.36±0.06 mm (from 2.03±0.05 mm pre implantation to 2.39±0.06 mm post implantation) in the eyes treated with the iSert injector. Light and scanning electron microcopy of the injector tips showed the following results: 1.) AutonoMe: 56% no damage, 39% slight scratches, 5% slight cracks. 2.) iSert: 5% slight scratches, 43% slight cracks, 52% extensions.

Conclusions:

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.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments 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, ... receives non-monetary benefits from a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a competing company