SEP 26, 2018
Comprehensive Ophthalmology, Glaucoma
Stephen Lane, MD, shared full results from the post-approval COMPASS-XT study at the 2018 ESCRS meeting in Vienna, Austria. The long-term safety data offer new insights into Alcon’s decision to pull the CyPass microstent from global markets last month.
The withdrawal announcement came after an analysis of 5-year outcomes from the extension trial implied that the stent is detrimental to the long-term health of the corneal endothelium.
During his presentation, Dr. Lane noted that patients who received the CyPass during cataract surgery had significantly higher mean endothelial cell loss (ECL) at year 4 (-18.4% vs. -7.5%; P=0.0001) and year 5 (-20.4% vs. -10.1%; P=0.032) compared with patients who underwent cataract surgery alone. The percentage of patients with greater than 30% ECL and the percentage of those with an endothelial cell density of less than 1,500 cells/mm2 was also significantly higher in the CyPass group.
The rate of ECL within the CyPass group strongly correlated with device position: a greater number of exposed retention rings was associated with higher long-term ECL—findings that Alcon alluded to in their letter to healthcare professionals on August 29, 2018. Patients who had 3 visible rings experienced an average ECL of 9.96% per year. By contrast, annual ECL rates for patients with 2, 1 or 0 visible rings were 6.02%, 2.74% and 1.39%, respectively.
Despite the concerning loss of endothelial cells, all patients had clear corneas at 51 months except for 1 mild case of corneal edema. Investigators trimmed the stent after determining the edema stemmed from endothelial touch, and the swelling resolved by 60 months.
The Ophthalmic Mutual Insurance Company (OMIC) is offering risk management pointers for physicians on their website. Additionally, recommendations for managing patients with an existing CyPass microstent are forthcoming from the American Society of Cataract and Refractive Surgery (ASCRS).