The device is surgically implanted into the supraciliary space of the eye through a small corneal incision, Dr. Nguyen explained.
The average patient age was 68, and the mean baseline was 24.5 mm Hg. Although the mean number of baseline medications was 2.2, 37% of those included in the trial used three or more medications. Sixty-three percent of patients were phakic.
Regarding patient safety, no sight-threatening complications or serious adverse events occurred.
“Seven patients had an IOP spike that resolved,” Dr. Nguyen said.
There were smaller numbers of patients that experienced transient hyphema, cataract progression, peripheral anterior synechiae, or a best-corrected visual acuity loss of two lines or greater. Seventeen percent of patients went on to require a trabeculectomy; 6% exited the study by choice, and 4.6% were lost to follow up.
Data at 1 year
There was a 30% decrease in mean IOP from baseline (24.5 mm Hg) to 6 months (17.7 mm Hg) to 1 year (16.7 mm Hg), Dr. Nguyen said, adding that the 1-year number reflects a total of 47 patients versus the 65 from baseline.
The mean number of medications needed dropped from 2.2 to 1.3 at 6 months and 1.5 at 1 year.
“With 1 year of data, using the CyPass as a stand-alone procedure shows good IOP control with less medication burden,” Dr. Nguyen said. “It’s relatively safe, and it’s very easy to implant. There is a quick learning curve, and it can offer good IOP reduction as a stand-alone procedure,” Dr. Nguyen concluded.