Clinical investigation of a new preloaded insertion system used during cataract surgery

Session Details

Session Title: Cataract Surgery Equipment

Session Date/Time: Monday 16/09/2019 | 08:30-10:30

Paper Time: 08:42

Venue: Free Paper Forum: Podium 3

First Author: : B.Cronin AUSTRALIA

Co Author(s): :    J. Domingo   B. Jackson   P. Janakiraman                       

Abstract Details

Purpose:

To allow surgeons experienced in small-incision cataract surgery to evaluate the clinical handleability and acceptability of a new insertion system for use in implanting the TECNIS 1-piece IOL during routine cataract surgery. The insertion system consists of a disposable modular cartridge preloaded with the IOL and a titanium reusable handpiece. The modular cartridge is hydrated using either BSS, ophthalmic viscosurgical device (OVD), or both.

Setting:

Prospective, multicenter, open-label, non-comparative clinical trial of approximately 90 eyes implanted with the IOL after cataract surgery using this new insertion system. The study is being conducted by five investigators in Australia and New Zealand. All participants underwent a preoperative exam (to assess eligibility), operative, and 1 day postop visit.

Methods:

The surgeons used their standard, small incision (2.2 – 2.4 mm) cataract extraction technique. Cataract removal utilized phacoemulsification/aspiration with or without laser fragmentation. Lenses were inserted in the capsular bag using the new insertion system. After the cataract surgery, the surgeon and surgical technician who prepared the IOL were given questionnaires that was either completed after each surgical case or at the end of the surgical day. The questionnaires (either Yes/No responses or using a 1-5 point scale) assessed the overall clinical performance, ease-of-use, and ergonomic design after use of the insertion system.

Results:

At the time of this abstract, 40 eyes were treated in this study. For overall performance rated by the surgeons, 97.5% (39/40) were satisfied to very satisfied with the insertion system. The surgeons reported that 100.0% (9/9) of the IOL deliveries were smooth and controlled and 100.0% (9/9) rated the overall ergonomics as excellent. When asked about the overall ease-of-use, 100.0% (9/9) of surgeons rated the insertion system as excellent/easy. Surgical technicians stated that the insertion system provided fast and consistent IOL loading (100.0%; 9/9). At the time of this abstract, no surgical complications or SAEs have been reported.

Conclusions:

This new preloaded delivery system was designed to provide a convenient, safe and simple means of delivering a flexible IOL by simplifying and standardizing the preparation of the IOL for implantation. The results of the clinical investigation demonstrate reasonable assurance of its safety and effectiveness. Surgeons and surgical technicians rated the delivery system high regarding overall clinical performance, ease-of-use, and device ergonomics.

Financial Disclosure:

is employed by a for profit company with an interest in the subject of the presentation