Eyeworld

Quang H. Nguyen, MD, is associate head, division of ophthalmology and direc- tor of the glaucoma service at Scripps Clinic in La Jolla, Calif. He is a consultant for Alcon and received compen- sation for his contribution to this supplement. He can be reached at nguyen.quang@ scrippshealth.org. C CyPass Micro-Stent is a novel approach for treating patients with mild to moder- ate glaucoma in conjunction with phacoemulsification. The supraciliary Micro-Stent provides an opportunity for ophthalmologists to perform a surgical treatment earlier in the disease. Surgeons have another option to control pressure better. CyPass Mi- cro-Stent is a novel approach for treating patients with mild to moderate glaucoma in con- junction with cataract surgery, and may possibly reduce the burden of topical glaucoma medication. CyPass Micro-Stent creates a controlled cyclodialysis and maintains a permanent cleft due to the "tenting" effect of the implant. It improves uveoscleral outflow similar to a mechanism of action of prostaglandin analog, which contributes greatly to pres- sure reduction. An attribute of CyPass Micro-Stent is the intuitive nature and the fact that it bypasses Schlemm's canal and collector channels that may be atrophic in glau- coma patients. The COMPASS trial, a piv- otal clinical trial of 2 years' duration, demonstrated the effectiveness CyPass Micro-Stent for lowering IOP with an excellent safety profile.* The COMPASS trial recruited 505 patients with randomization of 3:1 (3 patients with phacoemulsifi- cation + CyPass Micro-Stent (374 patients) to every 1 patient who underwent phacoemulsification alone (131 patients). This is the largest MIGS trial to date. Moreover, the COMPASS trial has washout IOP measurements at 1 and 2 years to truly demonstrate the effectiveness of CyPass Micro-Stent compared to phacoemulsification alone. Patients in both groups had similar baseline mean IOPs: 24.5±3.0 mmHg in the control group and 24.4±2.8 mmHg in the CyPass Mi- cro-Stent group. The study found early and sustained pressure reduction, with 72.5% of CyPass Micro-Stent patients compared with 58% of controls achieving 20% or more unmedicated IOP lowering compared with baseline at 24 months (Fig. 1). Mean IOP reduc- tion was 7.0 mmHg in the CyPass Micro-Stent group compared with 5.3 mmHg in the control group, a 32% increase in reduction of IOP with the Cypass Micro-Stent (p<0.0001). Patients' mean 24-month medication use was 20.6% lower in the CyPass Micro-Stent patients, and 72.4% of patients in the control group and 93.0% of CyPass Micro-Stent patients were medication-free at the end of two years (Fig. 2). No sight-threatening ad- verse events occurred in the CyPass Micro-Stent group. Visual acuity was high in both groups through 24 months, with more than 98% of patients achieving 20/40 or better best-corrected visual acuity. 1 The 1-year results of an ongoing open-label, in- terventional, multicenter study provide additional information on the use by Quang H. Nguyen, MD CyPass Micro-Stent is a successful treatment for cataract patients with mild to moderate glaucoma Case highlight I n my practice, a 68-year-old Caucasian woman underwent CyPass Micro-Stent in conjunction with uncomplicated phacoemulsification and posterior chamber IOL implantation. The right eye was operated on first, and the left eye underwent surgery a few weeks later. Preoperatively, best-corrected visual acuity was 20/100 in the left eye and 20/80 in the right eye. The patient had moderate glaucoma that was treated with a prostaglandin analog and fixed- dose combination therapy. Intraocular pressure was 18 mm Hg in the right eye and 17 mm Hg in the left eye. Postoperatively, best-corrected visual acuity was 20/20 in both eyes. Intraocular pressure in the immediate postoperative period was stable with no IOP spikes or hypotony. Intraocular pressure remained at 10 mm Hg in the right eye and 11 mm Hg in the left eye. The patient discontinued the fixed-dose combination within a week of surgery. IOP was still stable in the low teens, and the plan is to discontinue the prostaglandin analog in the coming weeks. • 32% increase in reduction of IOP with the CyPass Micro-Stent • 93% of CyPass Micro-Stent responders were medication- free at the end of 2 years *Primary outcome measure was unmedicated diurnal IOP reduction at 24 months versus cataract surgery alone at baseline. Secondary outcomes measures included mean change in 24 month DIOP from baseline and 24 month unmedicated mean IOP (between 6 mmHg to 18 mmHg) versus cataract surgery alone. Medication use at 24 months was also analyzed. The primary and secondary effectiveness analyses were performed using intent to treat (ITT) population.

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