Supraciliary Micro-Stent Implantation in Patients Refractory to Topical Glaucoma Therapy: 2-Year Results
To assess the safety and clinical outcomes at two years following supraciliary (SC) micro-stent implantation as a treatment for primary open-angle glaucoma (POAG) in patients refractory to topical glaucoma therapy.
In a prospective, multicenter, single-arm, open-label interventional clinical trial, subjects with diagnosed POAG (angles with Shaffer grade 3 or 4) and intraocular pressure (IOP) uncontrolled by topical medications (IOP ≥ 21 mmHg on 1 or more medications) underwent implantation of the CyPass Micro-Stent, a novel supraciliary implant. Glaucoma medications were discontinued at surgery and resumed at investigator discretion. Implantation of the device was performed using a transcameral, ab interno approach through a 1.5-mm clear corneal incision. Adverse events, postoperative IOP changes, and need for IOP-lowering medications during the first 24 postoperative months (24M) were monitored.
Sixty-five eyes of 65 patients were enrolled in the study. All devices were implanted successfully without any major intraoperative complications. During two years of follow-up, there were no major sight-threatening complications related to device implantation. Baseline mean ± SD medicated IOP was 24.4 ± 2.9 mmHg. At 12M and 24M, IOP was 16.7 ± 5.5 mmHg (32% reduction) and 16.5 ± 3.5 mmHg (31% reduction) respectively. Medication use also decreased from a mean of 2.2 medications to 1.7 medications at 24M. Secondary glaucoma surgery (trabeculectomy) was avoided in 75% of subjects.
The CyPass Micro-Stent provided safe and sustained IOP reduction over a 24-month period in POAG patients refractory to topical medications and may avoid the need for conventional glaucoma surgery in the majority patients.