ASCRS issues statement on CyPass withdrawal

An American Society of Cataract and Refractive Surgery task force made an official statement on monitoring and future intervention for patients with the CyPass implant after Alcon voluntarily withdrew the device from the market in late August due to safety concerns.

The 5-year results of the COMPASS-XT study showed patients implanted with the CyPass device who underwent cataract surgery experienced more endothelial cell loss compared with patients who underwent cataract surgery alone. Baseline cell counts were 2,432 cells/mm2 in CyPass patients and 2,433 cells/mm2 in control subjects. At 5 years, cell counts fell to 1,931 cells/mm2 in CyPass patients and 2,189 cells/mm2 in control subjects. The percentage loss of cells at 5 years was 27.2% in CyPass patients compared with 10% in control subjects.

This difference in cell count loss was not present at 2 years, which was the time period of the original COMPASS-XT study, Nathan Radcliffe, MD, a lead author of the ASCRS statement, told Healio.com/OSN.

“They did many careful analyses, but all of the data suggests that the risk of [endothelial cell loss] from CyPass was related to how deeply the CyPass was implanted. If you had a CyPass and it was implanted very deeply, or just partially deeply with zero or one of the retention rings visible in the anterior chamber, those eyes did well, and they did well in a similar way to cataract surgery alone, with roughly 2% endothelial cell loss per year,” Radcliffe said.

However, if two or three rings of the implant were visible in the anterior chamber, patients experienced about a 7% annual cell loss. While none of the eyes developed corneal problems within the 5-year study, it is logical that some of them would have if followed out further, Radcliffe said.

Radcliffe said physicians who have implanted the device should refer to the policies of their hospitals and ASCs on withdrawal of an implanted device.

“We recommend you follow that advice first. Secondly, most of these glaucoma patients are already being followed, so I think it’s wise to continue following these patients as we do with anyone with glaucoma,” Radcliffe said.

No pre-emptive surgical action needs to be taken for patients with the implant. If a patient has stents with two or three rings that are visible in the anterior chamber, then they should be followed carefully for any signs of corneal decompensation, Radcliffe said.

The stents should not change position over time and are stable after about 1 to 2 weeks. If an implant is placed accurately in a patient, the physician should be confident it will continue to be in the right position, he said.

If a patient has an implant that is not in a good position and is experiencing decompensation of the cornea, then Radcliffe said ASCRS believes a stent trimming procedure would be appropriate for the patient.

“A surgeon simply grabs the tip of the CyPass that is into the anterior chamber, applies some gentle traction, and then cuts the tip of the CyPass with intraocular scissors. That will make the CyPass shorter and should eliminate any CyPass-cornea contact. In the eyes that underwent the procedure in the COMPASS-XT study, and there were four of them, they did well. They had stabilization of endothelial cells,” Radcliffe said.

Francis S. Mah, MD, chair of the ASCRS committee, said the rapid, collaborative effort between the various entities of ASCRS came to a reasonable and responsible consensus statement based on the data for the benefit of patients and ASCRS members.

“Three members of the ASCRS Corneal Clinical Committee, Drs. John Berdahl, Preeya Gupta and Marjan Farid, and myself, the chair of the committee, worked on guidance for assessing and evaluating the cornea and endothelium for the task force. This shows the ability of ASCRS to bring together various experts and leaders for a timely consensus statement to guide ophthalmic surgeons and their patients,” he said.

For glaucoma, Douglas Rhee, MD, and Radcliffe lead a committee that included Leon Herndon, MD, Marlene Moster, MD, Thomas W. Samuelson, MD, and Steven Vold, MD. – by Robert Linnehan

Reference:

Preliminary ASCRS CyPass withdrawal consensus statement. http://ascrs.org/CyPass_Statement. Accessed Sept. 26, 2018.

For more information:

Francis S. Mah, MD, can be reached at Scripps Clinic, 10666 N. Torrey Pines Road, MS 214, La Jolla, CA 92037; email: mah.francis@scrippshealth.org.

Nathan M. Radcliffe, MD, can be reached at New York Eye Surgery Center, 1101 Pelham Parkway North, Bronx, NY 10469; email: drradcliffe@gmail.com.

Disclosures: Mah reports no relevant financial disclosures. Radcliffe reports he is a consultant for Alcon, Allergan, Glaukos and Ivantis.

An American Society of Cataract and Refractive Surgery task force made an official statement on monitoring and future intervention for patients with the CyPass implant after Alcon voluntarily withdrew the device from the market in late August due to safety concerns.

The 5-year results of the COMPASS-XT study showed patients implanted with the CyPass device who underwent cataract surgery experienced more endothelial cell loss compared with patients who underwent cataract surgery alone. Baseline cell counts were 2,432 cells/mm2 in CyPass patients and 2,433 cells/mm2 in control subjects. At 5 years, cell counts fell to 1,931 cells/mm2 in CyPass patients and 2,189 cells/mm2 in control subjects. The percentage loss of cells at 5 years was 27.2% in CyPass patients compared with 10% in control subjects.

This difference in cell count loss was not present at 2 years, which was the time period of the original COMPASS-XT study, Nathan Radcliffe, MD, a lead author of the ASCRS statement, told Healio.com/OSN.

“They did many careful analyses, but all of the data suggests that the risk of [endothelial cell loss] from CyPass was related to how deeply the CyPass was implanted. If you had a CyPass and it was implanted very deeply, or just partially deeply with zero or one of the retention rings visible in the anterior chamber, those eyes did well, and they did well in a similar way to cataract surgery alone, with roughly 2% endothelial cell loss per year,” Radcliffe said.

However, if two or three rings of the implant were visible in the anterior chamber, patients experienced about a 7% annual cell loss. While none of the eyes developed corneal problems within the 5-year study, it is logical that some of them would have if followed out further, Radcliffe said.

Radcliffe said physicians who have implanted the device should refer to the policies of their hospitals and ASCs on withdrawal of an implanted device.

“We recommend you follow that advice first. Secondly, most of these glaucoma patients are already being followed, so I think it’s wise to continue following these patients as we do with anyone with glaucoma,” Radcliffe said.

No pre-emptive surgical action needs to be taken for patients with the implant. If a patient has stents with two or three rings that are visible in the anterior chamber, then they should be followed carefully for any signs of corneal decompensation, Radcliffe said.

The stents should not change position over time and are stable after about 1 to 2 weeks. If an implant is placed accurately in a patient, the physician should be confident it will continue to be in the right position, he said.

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If a patient has an implant that is not in a good position and is experiencing decompensation of the cornea, then Radcliffe said ASCRS believes a stent trimming procedure would be appropriate for the patient.

“A surgeon simply grabs the tip of the CyPass that is into the anterior chamber, applies some gentle traction, and then cuts the tip of the CyPass with intraocular scissors. That will make the CyPass shorter and should eliminate any CyPass-cornea contact. In the eyes that underwent the procedure in the COMPASS-XT study, and there were four of them, they did well. They had stabilization of endothelial cells,” Radcliffe said.

Francis S. Mah, MD, chair of the ASCRS committee, said the rapid, collaborative effort between the various entities of ASCRS came to a reasonable and responsible consensus statement based on the data for the benefit of patients and ASCRS members.

“Three members of the ASCRS Corneal Clinical Committee, Drs. John Berdahl, Preeya Gupta and Marjan Farid, and myself, the chair of the committee, worked on guidance for assessing and evaluating the cornea and endothelium for the task force. This shows the ability of ASCRS to bring together various experts and leaders for a timely consensus statement to guide ophthalmic surgeons and their patients,” he said.

For glaucoma, Douglas Rhee, MD, and Radcliffe lead a committee that included Leon Herndon, MD, Marlene Moster, MD, Thomas W. Samuelson, MD, and Steven Vold, MD. – by Robert Linnehan

Reference:

Preliminary ASCRS CyPass withdrawal consensus statement. http://ascrs.org/CyPass_Statement. Accessed Sept. 26, 2018.

For more information:

Francis S. Mah, MD, can be reached at Scripps Clinic, 10666 N. Torrey Pines Road, MS 214, La Jolla, CA 92037; email: mah.francis@scrippshealth.org.

Nathan M. Radcliffe, MD, can be reached at New York Eye Surgery Center, 1101 Pelham Parkway North, Bronx, NY 10469; email: drradcliffe@gmail.com.

Disclosures: Mah reports no relevant financial disclosures. Radcliffe reports he is a consultant for Alcon, Allergan, Glaukos and Ivantis.