In the wake of Alcon’s voluntary recall of the CyPass micro-stent following the high rate of endothelial adverse events in the COMPASS-XT study , the American Society of Cataract and Refractive Surgery (ASCRS) formed a task force of glaucoma and cornea specialists to evaluate the data and provide clinical recommendations.
The Preliminary ASCRS CyPass Withdrawal Consensus Statement, released yesterday, advises patients who received the CyPass to continue following up with their eye care providers at appropriate intervals and possibly consider more frequent corneal evaluations.
For practitioners, clinical examination alone may be appropriate for monitoring patients with the CyPass in the absence of clinically significant corneal decompensation; intervention should be limited to instances when clinically apparent or functionally significant changes occur, according to the statement.
When performing gonioscopy on patients, ASCRS says, practitioners should be vigilant for the presence or absence of contact between the corneal endothelium and the CyPass device, the position of the device lumen anterior to Schwalbe’s line and the number of retention rings visible in the anterior chamber.
The statement noted the apparent correlation between CyPass implantation depth and the rate of endothelial cell loss. The task force also employs the COMPASS study’s use of the number of visible retention rings to grade implantation depth. If only one ring of the CyPass, or none at all, is visible in the anterior chamber by gonioscopy and no clear evidence of corneal decompensation exists, continue to monitor patients in lieu of intervention, according to ASCRS. If more rings are visible, a greater risk of corneal endothelial cell loss exists.
If corneal decompensation has developed and more than one retention ring is visible, consider recommending surgery to reposition the CyPass or trim the proximal end; however, ASCRS notes that repositioning or deeper implantation is safest only within seven to 10 days of initial implantation. The group expressed concern over the potential for fibrosis around and possibly through the filtration holes of the micro-stent, and recommended trimming the proximal end of the device as the preferred procedure if the physician and the patient should desire intervention.
|American Society of Cataract and Refractive Surgery. Preliminary ASCRS CyPass withdrawal consensus statement. http://ascrs.org/CyPass_Statement. September 25, 2018.|