Clinical investigation of a new laser device to assess its efficacy and safety for the creation of anterior capsulotomies in cataract patients

Session Details

Session Title: Capsular Management

Session Date/Time: Sunday 23/09/2018 | 16:30-18:00

Paper Time: 16:48

Venue: Room A4

First Author: : R.Packard UK

Co Author(s): :    P. Stodulka                    

Abstract Details

Purpose:

To assess the efficacy and safety of a new laser device(CAPSULaser) for the creation of anterior capsulotomies during cataract surgery and to prove non-inferiority when compared to manual capsulotomy.

Setting:

Gemini Clinic Zlin Czech Republic

Methods:

A single-centre prospective, open, controlled, multi-surgeon study assessed cataract operations with the anterior capsulotomy performed using a continuous laser (CAPSULaser) targeted on a specially formulated trypan blue (CAPSULBlue) stained anterior capsule through a custom-made contact lens compared to manual capsulotomy prior to IOL implantation. The aspects of efficacy and safety were investigated based on video recording during the surgery as well as in postoperative examinations. 125 patients were recruited divided between the laser and control arms.

Results:

The study 125 patients with normal cataract demographics. In the laser arm (63 eyes) all anterior capsules were successfully stained with a single application of trypan blue resulting in a visible blue colouration. The laser treated eyes had 100% free-floating capsulotomies. The mean diameter,, circularity and centration precision of the resultant capsulotomies for the laser group were determined to be superior to the manual group with a statistical p-value < 0.05. In the laser group 86% within 0.1mm of 5.0mm. For the manual group, 44% within 0.1mm (p-value ≤0.0001). There were no capsulotomy or cataract surgery related serious adverse events.

Conclusions:

A specially formulated trypan blue was safe and efficacious for staining the anterior capsule and for use with this new continuous laser. The laser was safe and efficacious when used with an intraocular dye for the creation of anterior capsulotomies during cataract surgery with greater sizing and circularity accuracy than can be achieved manually

Financial Disclosure:

... has significant investment interest in a company producing, developing or supplying product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented