Cypass Micro Stent
Minimally invasive glaucoma surgery at the time of cataract surgery.
The two-year COMPASS trial is the largest randomized, controlled MIGS trial completed to date, and included >500 patients with baseline and terminal washout1 Implanted at the time of cataract surgery, the CyPass® Micro-Stent was shown to lower IOP for more patients than cataract surgery alone1
The clinical performance of the CyPass Micro-Stent system was evaluated by a study of 505 patients diagnosed with POAG. 374 patients were randomized to the CyPass Micro-stent in combination with cataract surgery, and 131 patients were randomized to cataract surgery alone. The study evaluated the percentage of patients with reduction of at least 20% in mean diurnal IOP from baseline and adverse events (AEs) for 24 months after implantation. Of the patients randomized to the stent, 72.5% achieved a significant lowering of their IOP, compared to 58.0% of patients who had cataract surgery alone.
There were no reports of patients implanted with the CyPass Micro-Stent experiencing loss of light perception, endophthalmitis, suprachoroidal hemmorrhage, diplopia, wound leak, flat anterior chamber, or bleb complications. The most serious AEs reported were rare instances of hypotony maculopathy, peripheral anterior choroidal effusion, intraocular lens (IOL) subluxation and corneal compromise. The most common safety concerns were related to bleeding, inflammation, and damage to angle tissue (i.e., iridodialysis, larger than expected cyclodialysis cleft, ciliary body edema). Due to the small size of the CyPass Micro-Stent, some patients experienced device malposition, device movement, and tube obstruction.