The automated capsulotomy device received FDA approval in June 2017. It features a control panel and disposable handpiece that introduces a soft, clear silicone suction cup and nitinol capsulotomy ring. The handpiece tip is passed through a clear corneal incision (≥2.2 mm) into the viscoelastic-filled anterior chamber.
After the capsulotomy ring unfolds, it is centered on top of the capsule or potentially on the visual axis if the surgeon desires. Suction is applied to remove viscoelastic from between the capsulotomy ring and the capsule, bringing the ring and capsule into direct apposition without creating any tension on the lens or zonules. Then, electrical energy is applied and the capsule is cut through water phase transition.
“A complete 360° capsulotomy is created instantaneously using a minimal amount of energy with application of a 4-millisecond pulse train,” Dr. Quesada said. “After reversing the suction, viscoelastic is reintroduced to release the device from the capsule, and then it is removed.
"This device is easy to use, and it has no effect on patient flow because it requires no change in the usual surgical routine,” he added.
The patients included in the first clinical evaluation of the automated capsulotomy device ranged in age from 49 to 86 years. Twelve of the 38 eyes had a grade 4 (LOCS II) cataract with best-corrected visual acuity of 20/200 or worse. Two eyes had significant pterygium that limited capsulotomy path visualization, three eyes had poor pupil dilation (≤ 4 mm), and one eye had 6 clock hours of zonular dialysis.