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UPDATE 16 ASCRS CyPass Withdrawal Task Force Leads: Douglas Rhee, MD, Nathan Radcliffe, MD, Francis Mah, MD Glaucoma: Leon Herndon, MD, Marlene Moster, MD, Thomas Samuelson, MD, Steven Vold, MD, Ike Ahmed, MD Cornea: Ken Beckman, MD, FACS, John Berdahl, MD, Marjan Farid, MD, Preeya Gupta, MD Preliminary ASCRS CyPass withdrawal consensus statement Risk assessment and diagnos- tic monitoring: Gonioscopy should be performed on patients with an indwelling CyPass device with atten- tion to device position—the pres- ence or absence of contact between the corneal endothelium and the CyPass device, the position of the device lumen anterior to Schwalbe's line, and to the number of retention rings visible in the anterior chamber. The group noted that numerous conditions and therapeutic interven- tions can result in ECL, but inter- vention is generally limited to when clinically apparent or functionally significant changes occur. Slit lamp examination to assess for focal or diffuse corneal stromal edema and/ or presence of guttata is recom- mended. Symptoms of morning blurriness or increasing glare with bright lights could be indicative of clinically/functionally significant corneal edema, but there are numer- ous confounding conditions with these same symptoms limiting the diagnostic value of symptomatology alone. If quantification is desired, baseline and follow-up corneal pachymetry, for corneal thickness measurements, as well as specular microscopy, for endothelial cell counts, could be considered. How- ever, both of these methodologies have significant variability of mea- surement that are inherent to the techniques, e.g., variations in mea- surements can occur due to lack of consistency in applanation location among each measurement taken. Clinical examination alone may be appropriate for monitoring patients with indwelling CyPass devices. When to consider intervention The CyPass Micro-Stent Instruc- tions For Use (IFU) states, "in the absence of clinical sequelae, de- vice adjustment or removal is not recommended" (www.accessdata. fda.gov/cdrh_docs/pdf15/p150037d. pdf). According to the CyPass IFU, In all cases, the corneas remained clear and the ECC remained stable at month 60. One patient in the COMPASS trial (2-year follow up) did undergo a Descemet's stripping endothelial keratoplasty (DSEK) at month 13 with the procedure being thought to be related to the CE and not to the CyPass, which was well positioned with 1 ring visible. Some eyes with >2 rings visible in the anterior chamber experienced min- imal ECL. Thus, clinically relevant, judicious, and periodic monitoring of corneal health is advised. Summary of Task Force discussion of results: The ECL in the control group in the COMPASS-XT study experienced a very low rate of ECL, even compared to historic norms. The previously reported pseudopha- kic ECL rate is roughly 2%/year; a rate of 0.36%/year ECL was observed in control COMPASS-XT patients. Additionally, it was noted that, depending on glaucoma severity, cataract alone may not be the best comparison group for eyes receiv- ing CE with the CyPass device, but rather eyes receiving CE and other glaucoma drainage procedures. Diagnostic monitoring options Notification: Physicians who have implanted CyPass devices should refer to their hospitals, ASCs, or practice policies regarding patient notification for medical implants that have been voluntarily with- drawn from the market. Patients who have received CyPass devices should continue to be followed by their eye care provider(s) at appro- priate intervals. (n=33) and at 60 months to 1931 in CE with CyPass (n=163) vs. 2189 in the control group (n=40). This rep- resented an 18.4% reduction in ECL in CE with CyPass vs. 7.5% ECL in the control group at month 48, and to a 60-month CE with CyPass ECL of 20.5% compared to 10.1% in the control group. The difference in ECL between CE with CyPass and control decreased slightly between 48 and 60 months. ANSI Z80:27 standards consider 30% ECL at 5 years to be meaningful. The percentage loss was 27.2% in CyPass vs. 10% in controls. There appears to be a correlation between CyPass implantation depth and rate of ECL. In the COMPASS- XT study, anterior chamber angle photos were taken, and the number of rings visible were used to grade implantation depth. There were 15 subjects in the COMPASS-XT trial where the number of visible rings was reported as changed between trial visits. Seven of these were re- ported to have more rings becoming visible with time, 7 were reported to have fewer visible rings with time, and there was 1 subject with an increase in visible rings followed by a decrease. It is possible that these changes were a result of observer variability. For eyes with no rings showing (n=69), the rate was 1.39%/year, for 1 ring showing (n=98) 2.74%/year, and for 2–3 rings showing (n=27) 6.96%/year. No patients in COM- PASS-XT required corneal surgery by 5 years. Four patients underwent a CyPass trimming procedure for a CyPass with 3 rings visible in the anterior chamber that was observed in the first postoperative week. Purpose On August 29, 2018, Alcon volun- tarily withdrew the CyPass device from the market due to safety concerns reportedly based on 5-year data from the COMPASS-XT study that indicate a higher rate of endo- thelial cell loss (ECL) in patients re- ceiving cataract extraction (CE) plus CyPass versus CE alone. This ASCRS Task Force was convened to develop an understanding of the data and a preliminary consensus on monitor- ing and treatment options. Overview of the results provided by Alcon The results suggest a relationship between CyPass implant depth and ECL. Stents with greater anterior chamber exposure may have greater ECL at 5 years. Early migration of the implant has been observed; the potential for migration remains an important variable to be considered for long-term diagnostic monitoring. The COMPASS-XT study fol- lowed a smaller number of patients than the COMPASS trial. By 60 months, there were roughly 200 CyPass patients and 53 control patients. Of note, as the study was being assembled at 36 months, there are too few (n=36 patients) pre- senting at 36 months to make any meaningful comparisons. Aside from ECL, outlined below, there were no other significant safety concerns. At 5 years, there was more ECL in CE with CyPass compared to CE alone (control). Baseline endothelial cell counts (ECCs) were 2432 for CyPass and 2434 for control, falling at 48 months to 1992 in CE with CyPass (n=116) vs. 2303 in control

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