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Important update on the CyPass Micro-Stent: On August 29, 2018, Alcon announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market and advised surgeons to immediately cease further implantation with the CyPass Micro-Stent. Alcon's decision and corresponding recommendation was based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study. At five years, the CyPass Micro-Stent group experienced statistically significant endothelial cell loss compared to the group who underwent cataract surgery alone. For more information, please read the Novartis press release.
Some devices required for minimally invasive surgery are already available, such as XEN and Cypass, but experts around the United States are hard at work creating new micro-tools that address the unique treatment needs of glaucoma patients and help the dialogue move even farther beyond the traditional “medication or major surgery” conversation. MIGS falls between the two, offering help that can be implemented long before a more invasive or complicated procedure is needed.
Like traditional glaucoma surgery, MIGS lowers intraocular pressure by allowing excess fluid to drain from the eye. Then it keeps on working to maintain just the right amount of fluid needed to sustain normal intraocular pressure, which means people can cut back on, or possibly eliminate, medications. The innovation that makes MIGS so exciting is that it uses microscopic-sized equipment that only requires a tiny incision. This type of surgery takes less time than standard surgery and causes significantly less trauma to the eye. As a result, it’s safer and less intimidating for the patient.
Trabectome and the iStent are two types of MIGS devices approved by the FDA. Trabectome surgery lowers eye pressure by removing part of the tissue that blocks the natural drainage system. It has been approved since 2004, and has a good track record. However, it’s typically used to treat people who also need cataracts removed.
The iStent, which was approved in 2012, is inserted into the eye, where the stent bypasses the blockage and guides fluid flow out of the eye. And if you’re wondering about how an implanted stent might look or feel—you’d never notice it. The iStent is the smallest device ever approved by the FDA. It’s only 0.04 inches long!1
Even after MIGS devices are approved, the research doesn’t stop. The experts continue to track patients so they can learn how well eye pressure was controlled in the years after surgery and to record long-term visual acuity. They’ll also take note of any side effects and learn about the impact of MIGS on quality of life. All of this information will improve the procedure and help future patients make treatment decisions.
The glaucoma community should be excited by these developments, but celebration must also be tempered with the understanding that work still needs to be done to make MIGS available to as many people as possible. As it stands now, only certain people are candidates for iStent and Trabectome. For example, both work best in those with mild to moderate glaucoma, minimal vision loss, and who can keep eye pressure controlled with one or two medications.2 People who take blood thinners like Warfariin or aspirin my not be qualified for either procedure.
Future research will define who will benefit the most from MIGS procedures currently in clinical trials, and hopefully reveal how to help those with glaucoma live their best life.
1 “Microinvasive Glaucoma Surgery (MIGS),” April 2016, http://eyewiki.aao.org/Microinvasive_Glaucoma_Surgery_(MIGS)
2 “Glaucoma Surgery Series: Minimally Invasive Glaucoma Surgeries (MIGS),” May 2014, http://www.brightfocus.org/glaucoma/article/glaucoma-surgery-series-minimally-invasive-glaucoma-surgeries-migs
Last reviewed on October 08, 2018