Eyeworld

I JULY 2019 | EYEWORLD | 37 toward doing more advanced procedures," he said. "In someone with less advanced disease, the argument could be made that you don't want to subject these patients to the risk of corneal injury down the road." Dr. Herndon said he'd like to see CyPass or something similar come back to the market. If it did, he said there would need to be an educational campaign about how to place such devices properly. For Dr. Holland, it's a discussion that's needed among the surgeon, patient, and their family. "I think we have to have informed consent for the patient about the risk of cell loss and let the doctor, the patient, and the family decide together," he said. "I'm not opposed to the device, but I think everyone should know what the risks are." Editors' note: Dr. Herndon and Dr. Rhee were part of the ASCRS CyPass Withdrawal Task Force. From a cornea specialist's perspective, Edward Holland, MD, said he thinks patients should be followed with periodic endothelial cell counts. If CyPass is extending more than desired into the anterior chamber, endothelial cell counts could inform the surgeon if the device should be trimmed. If the cell count is good, the patient could be followed every 6 months to monitor for change and consider revision, if necessary, Dr. Holland said. "The question then becomes if the device is in a good position or if it's already been trimmed—what's the value of a cell count because then there is nothing to do at that time if the patients are progressing with losing cells," he said. "I feel strongly that information is valuable, and the patients and their families would like to know. Endothelial cell count is the only screen- ing test that can predict the risk of corneal edema. Changes in pachymetry and on slit lamp examination can only document corneal edema and by then it's too late. I would advocate for endothelial cell counts on a regular basis for all of these patients," Dr. Holland said later. Dr. Herndon said he does not routinely get specular microscopy for endothelial cell den- sity on these patients but will perform careful gonioscopy, will look at pachymetry, and will act accordingly. Overall, Dr. Rhee said he would like to have CyPass back on the market and he doesn't need any additional safety data to be comfortable with it, though, of course, more data would be nice. "I think we could return it to the market, and I would just change it in my lineup. It would be worthy to reevaluate where in the armamentarium it would be optimally used," he said, explaining that while such a device might not be good for ocular hypertension or early stage glaucoma patients, it is a lower risk option than a trab or tube shunt. Dr. Herndon expressed a similar sentiment. "The argument could be made that we usually reserve traditional procedures—trab and tube shunts—for patients with more severe disease where the risk-benefit ratio is leaning About the doctors Leon Herndon, MD Professor of ophthalmology Chief of the Glaucoma Division Duke University School of Medicine Durham, North Carolina Edward Holland, MD Director of Cornea Services Cincinnati Eye Institute Professor of clinical ophthalmology University of Cincinnati Douglas Rhee, MD Chair Department of Ophthalmology and Visual Sciences Case Western Reserve University Cleveland References 1. Lane S. Overview of the results from the 5 yr follow up study of the CyPass MicroStent. ESCRS Scientific Presentation. Sept. 24, 2018. 2. Update: Potential eye damage from Alcon CyPass Micro-Stent used to treat open-angle glau- coma. FDA Safety Commission. Oct. 24, 2018. Accessed May 14, 2019. www.fda.gov/medical-de- vices/safety-communications/ update-potential-eye-damage- alcon-cypass-micro-stent-used- treat-open-angle-glaucoma-fda- safety. 3. Preliminary ASCRS CyPass withdrawal consensus statement. ASCRS CyPass Withdrawal Task Force. September 2018. Accessed May 15, 2019. ascrs.org/ CyPass_Statement. From left: CyPass placed appropriately CyPass placed poorly, which could increase the risk of endothelial cell loss Source (all): Leon Herndon, MD The ASCRS CyPass Withdrawal Task Force suggested gonioscopy to evaluate any contact between the device and corneal endothelium, the position of the device lumen anterior to Schwal- be's line, and the number of retention rings visible in the anterior chamber. Slit lamp examination to assess focal or diffuse corneal swelling and/ or guttata was also recommended. Pachymetry and specular microscopy could be considered, the statement read. Only clinical monitoring was recommended by the task force when 0–1 ring of the device was visible in the anterior chamber. The task force advised monitoring, though perhaps more frequently, in eyes with 2–3 rings visible but with no clinically significant corneal decompensa- tion. If there is corneal decompensation with more than 1 ring visible, trimming the proximal end was listed as the preferred intervention, with deeper implantation considered safe within 7–10 days af- ter implantation. The task force expressed concern about device removal due to fibrosis.

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