Posters

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

Poster Details

First Author: D.Black AUSTRALIA

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

Abstract Details

Purpose:

To evaluate the clinical handleability and acceptability of a new insertion system (TECNIS SimplicityTM) J&J Surgical Vision, Inc) for use in implanting the TECNIS 1-piece IOLs during routine cataract surgery. The delivery system is preloaded with the IOL and is completely disposable after use. The cartridge is hydrated using either BSS or ophthalmic viscosurgical device (OVD).

Setting:

Prospective, multicenter, open-label, non-comparative clinical trial of approximately 65 eyes implanted with the IOL after cataract surgery using this new insertion system. The study is being conducted by six 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 utilised 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, 33 eyes were treated in this study. For overall performance rated by the surgeons, 100.0% (33/33) were reported as acceptable. The surgeons reported that 100.0% (21/21) of the IOL deliveries were smooth and controlled and 95.2% (20/21) rated the overall ergonomics as excellent. When asked about the overall ease-of-use, 95.2% (20/21) of surgeons rated the insertion system as excellent/easy. Surgical technicians stated that the insertion system provided fast and consistent IOL loading (100.0%; 21/21). One SAE of IOP requiring treatment (not related to the device) was reported.

Conclusions:

This new preloaded, disposable delivery system was designed to provide a convenient and safe 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 highly favorable 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