Clinical results using a thermal laser (CAPSULaser) to assess its efficacy and safety for the creation of anterior capsulotomies in cataract surgery when compared with manual capsulorhexis

Session Details

Session Title: Cataract Surgery Equipment/Instrumentation/Surgical Devices

Session Date/Time: Monday 09/10/2017 | 16:30-18:00

Paper Time: 17:37

Venue: Room 4.4

First Author: : P.Stodulka CZECH REPUBLIC

Co Author(s): :    R. Packard                    

Abstract Details

Purpose:

The purpose of this 120 patient clinical study was to prove non-inferiority for this laser in capsulotomy creation to manual capsulorhexis. The study looked at the efficacy and patient safety of the CAPSULaser device for the creation of anterior capsulotomies.

Setting:

A private ophthalmic clinic (Gemini Eye Clinic in Zlin, Czech Republic)

Methods:

120 eyes of 120 patients were studied excluding any with pre-existing conditions. Enrolment aimed to achieve homogeneity between the laser and manual control groups in terms of age and cataract grade. The cataract surgeries were video recorded, and in order to calibrate the capsulotomy diameter, a calibrated gauge was placed in the anterior chamber following completion of each capsulotomy. Two independent reviewers studied the videos, calibrated the dimensions and measured these critical dimensions. Visual acuity and the appearance of the anterior capsule were recorded at 1 week, 1 month and 3 months.

Results:

The study found no laser-related complications. Most noticeably the resultant laser capsulotomy rim was tear-resistant and no anterior tears were observed in this group. The laser group was shown to have greater precision and consistency of the diameter and circularity . Average laser capsulotomy diameter was measured at 5.00 mm +/- 0.05 mm p<0.01. Laser capsulotomy circularity was over 99% circular when compared to manual p<0.01. Finally, the best corrected visual outcomes of the laser group were non-inferior to the group that received manual continuous curvilinear capsulorhexis.

Conclusions:

The results of this prospective controlled 120 patient study demonstrated that a thermal laser (CAPSULaser) created consistently sized and circular capsulotomies with no patient safety issues when compared to manual capsulorhexis.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented