Efficacy and safety of a new selective laser device to create anterior capsulotomies in cataract patients

Presented in part at the ASCRS•ASOA Annual Meeting, Washington, DC, USA, April 2018
Authors: Pavel Stodulka MD, PhD, FEBOS-CR1Richard Packard MD, FRCS, FRCOphth2David Mordaunt PhD3

1. Charles University, Prague, Czech Republic
2. Arnott Eye Associates, London, United Kingdom
3. EXCEL-LENS, Inc., Los Gatos, California, USA

Purpose

To compare the efficacy and safety of anterior capsulotomy creation with a new selective laser device (CAPSULaser) with those of manual capsulotomies.

Setting

GEMINI Eye Clinic, Zlin, Czech Republic.

Design

Prospective case series.

Methods

Patients were placed in cohorts based on age and cataract grade and randomly allocated to have laser capsulotomy or manual continuous curvilinear capsulorhexis (CCC). The anterior capsule was stained with microfiltered trypan blue 0.4%. The anterior capsulotomy was created with the laser device focused on the anterior capsule through a custom patient interface lens. Intraoperative video analysis with the use of an intraocular ruler and postoperative examinations were used to assess safety and efficacy (accuracy of capsulotomy size, circularity, centration).

Results

No intraoperative complications occurred in the laser group or the manual group. All capsulotomies in the laser group were free-floating with no tags or tears. The mean capsulotomy diameter was 5.03 mm overall (range 4.8 to 5.2 mm, laser group; 4.4 to 5.8 mm, manual group). In the laser group, all the capsulotomies were within 0.1 mm ± 0.1 (SD) of the target. The circularity accuracy was greater than 99.0% ± 1.0%; the mean centration of the capsulotomy in relation to the intraocular lens (IOL) was 0.1 ± 0.1 mm. All parameters were statistically significant (P < .01). The IOL–capsulotomy overlap was 360 degrees in all laser cases.

Conclusions

Selective laser capsulotomy using a new proprietary trypan blue formulation was safe and effective in cataract surgery. The sizing, circularity, and centration of the laser capsulotomy were more accurate than those of the manual CCC, resulting in consistent 360-degree IOL coverage.