Alcon withdrew the stents after preliminary data from the COMPASS-XT study found an increased risk of endothelial cell loss (ECL) among patients who were implanted with the stent during cataract surgery compared to patients who underwent cataract surgery alone.
Patients who received the CyPass Micro-Stent are at risk of losing cells in the protective outer layer of the eye (cornea), according to an FDA Safety Communication issued on Sept. 14. Endothelial cells line the inner surface of the eye’s cornea and are important in keeping vision clear. These cells do not regrow after they are damaged, the agency said. Endothelial cell loss may be associated with damage to the cornea including:
- Eye pain
- Reduction in vision
- Potential need for corneal transplant
The problems with the Alcon stent were not evident at the 2-year mark following the patients’ surgery, when COMPASS found similar ECL in the CyPass and cataract surgery-only groups. Based on these results, FDA approved the CyPass Micro-Stent for long-term IOP control in patients with mild-to-moderate primary open-angle glaucoma.
However, the recently completed COMPASS-XT study found a rise in ECL in the CyPass group. In a letter to physicians, Alcon’s chief medical officer, Stephen Lane, MD, said the damage is likely a result of the stent’s position within the angle. He noted that the ECL correlated with the number of retention rings noted on clinical examination with gonioscopy, particularly when 2 or more retention rings were visible.
“Based on this new information, we are advising surgeons to immediately cease further implants with the CyPass microstent and to return any unused devices to Alcon,” Lane wrote.
If you received a CyPass Micro-Stent, FDA recommends that you talk to your opthamologist immediately. They will provide you with your options and help you decide what to do, FDA said.