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Capsulotomy device offers consistent outcomes, ease of use
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A disposable capsulotomy device is easy to use and provides consistent outcomes in challenging cataract cases, according to a study.
The Zepto precision pulse capsulotomy device (Mynosys Cellular Devices) was used in a study of 38 eyes that underwent cataract surgery in patients from El Salvador. The cohort included “very difficult cataract cases” to purposely stress the efficiency of the device, Kevin Waltz, MD, OD, told Ocular Surgery News.
“We’ve developed an automated capsulotomy device that can function with small pupils, without dye and with challenging anatomy. We did the study in San Salvador with some very difficult cataracts purposefully to stress the device. Our typical patient had worse than 20/200 vision and had a little bit of trauma; some of them had white intumescent cataracts. These were not average run-of-the-mill cataracts. The patients oftentimes didn’t dilate very well, and what we noticed is that the device worked very well in all circumstances. We didn’t have a control arm, but our belief is if we did not have the device, we would have actually had more difficulties than what we did,” Waltz said.
Methods
The study included 38 eyes that underwent cataract surgery with an anterior capsulotomy performed with the device, which consists of a superelastic nitinol capsulotomy ring covered by a soft silicone suction cup. Waltz and colleagues performed the procedures through a 2.2-mm corneal incision in the presence of an ophthalmic viscosurgical device.
In all cases, a complete 360° free-floating capsulotomy was created with no complications followed by intracapsular IOL fixation.
The device, Waltz said, allowed the surgeon to complete the procedure in the same amount of time as a manual technique, but with more consistency and similar patient outcomes.
Its design allows surgeons to use the device in challenging cases, such as those involving intumescent cataracts, zonulopathy and poorly dilated pupils, Waltz said.
“We found that we could do the capsulotomy safer, more consistently and more reliably in the same amount of time as we could do with a manual procedure. We also didn’t require as many devices to do the capsulotomy. Sometimes you would put in a ring or hooks in order to enlarge the capsule or enlarge the pupillary opening, but with this device you actually could place the device behind the pupil, get a good capsulotomy with the size you wanted and then proceed with the surgery,” he said.
No intraoperative complications were observed in any of the eyes, and no capsule contractions were observed 8 months postoperatively.
FDA clearance
The FDA granted 510(k) clearance to Mynosys for the device in June. It was slated for commercial release in the U.S. in August and was already released this year in India, Germany, Australia and New Zealand, according to Waltz.
“We’ve got about 2,800 commercial applications of the device. These have, of course, included challenging cataracts, but this device has also found significant use in the premium channel market overseas. We haven’t had any reported problems of it yet, so we’re off to a great start. We’re seeing patients and doctors, in particular, who have really enjoyed it. ... We’ve seen very good results consistently across those cultures,” he said. – by Robert Linnehan
- Reference:
- Waltz K, et al. J Cataract Refract Surg. 2017;doi:10.1016/j.jcrs.2017.01.023.
- For more information:
- Kevin Waltz, MD, OD, can be reached at Ophthalmic Research Consultants, 5051 Buttonwood Crescent, Indianapolis, IN, 46228; email: kwaltz56@gmail.com.
Disclosure: Waltz reports he is a consultant for and investor in Mynosys Cellular Devices.