Long-Term Results of Supraciliary Micro-Stent Implantation in Patients Refractory to Topical Glaucoma Therapy

Nguyen, Quang

Long-Term Results of Supraciliary Micro-Stent Implantation in Patients Refractory to Topical Glaucoma Therapy

Sunday, April 27, 2014: 1:06 PM

Room 155 (Boston Convention and Exhibition Center)

Quang H. Nguyen, MD, Scripps Clinic, La Jolla, CA, USA

Tsontcho Ianchulev, MD, MPH, UCSF, San Mateo, CA, USA

Helmut R. Hoeh, MD, Dietrich-Bonhoeffer-Klinikum, Neubrandenburg, Germany

Magda Rau, MD, Augenklinik Cham, Cham, Germany

Swaantje Grisanti, MD, PhD, University Eye Hospital Luebeck, Lübeck, Germany

Narrative Responses:

Purpose
Assess the safety and clinical outcomes of supraciliary micro-stent implantation as a treatment for open-angle glaucoma (OAG) in patients refractory to topical glaucoma therapy.

Methods
Subjects with intraocular pressure (IOP) uncontrolled by 1-4 topical medications (IOP ≥ 21 mmHg) were enrolled in a multi-center, prospective, single-arm, interventional study in 8 European sites. All subjects underwent implantation of the CyPass Micro-Stent (Transcend Medical, Inc, Menlo Park, CA) as a standalone procedure and were followed for 12 months. Endpoints included IOP reduction and ocular hypotensive medication use through the follow-up period.

Results
A total of 65 subjects were enrolled. Nearly all subjects were candidates for conventional glaucoma surgery (e.g., trabeculectomy or tube implantation) at the time of enrollment. All subjects were successfully implanted with the CyPass Micro-Stent. There were no serious intraoperative complications or major adverse events through 12 months of follow-up. At baseline (n=65), mean medicated IOP was 24.5 mmHg. At 12 months (n=48), mean IOP decreased to 16.7 mmHg (n=48), a 32% reduction from baseline (p<0.0001 using Wilcoxon signed rank test). Mean medication use also decreased from 2.2 medications to 1.5 medications at 12 months.

Conclusion
The CyPass Micro-Stent provided safe and sustained IOP reduction in OAG patients refractory to topical medications. The data suggests that the CyPass Micro-Stent can serve as a safe and effective standalone treatment prior to more invasive glaucoma surgery (tube implantation or trabeculectomy).