This is a supplement to EyeWorld Magazine.
Issue link: https://supplements.eyeworld.org/i/824592
Innovative Technologies Designed to Meet the Needs of Surgeons and their Patients 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 of the CyPass Micro-Stent for the surgical treatment of open-angle glaucoma when implanted in con- junction with cataract surgery. The study included 167 eyes of 142 patients with open-angle glaucoma who underwent combined phacoemulsification with in- traocular lens insertion and Micro-Stent implantation into the supraciliary space. Patients were divided into two groups: those with a baseline IOP of 21 mmHg or higher (65 patients) and those with a medicated baseline IOP of less than 21 mmHg (102 patients). Glau- coma medications were discontinued or tapered at surgery. Patients' mean fol- low-up was 294±121 days, and no major intraoperative or postoperative compli- cations occurred. Patients' mean preoperative baseline IOP was 20.2±6.0 mmHg, and their mean number of IOP-lowering medications was 2.0±1.1. Patients with a medicated baseline IOP of 21 mmHg or higher demon- strated a 35% decrease in mean IOP and a 49% re- duction in mean glaucoma medication usage. Those with a medicated baseline IOP of less than 21 mmHg had a 75% reduction in mean medication usage while maintaining a mean IOP of less than 21 mmHg. Mean IOP at 12 months was 15.9±3.1 mmHg in all eyes, which was a reduction from baseline of 14%. 2 In summary, the CyPass Micro-Stent, in conjunction with phacoemulsification, effectively demonstrated sustained unmedicated IOP lowering along with an excellent safety profile as demonstrated in the COMPASS trial. This is truly a special time for ophthal- mologists to treat glauco- ma in patients undergoing cataract surgery. Surgeons now have another MIGS option for their patients to control IOP at the time of cataract surgery with the high potential of reducing the glaucoma medication burden. n References 1. Vold S, Ahmed II, Craven ER, et al; CyPass Study Group. Two-year COMPASS trial results: Supracili- ary microstenting with phacoemulsification in pa- tients with open-angle glaucoma and cataracts. Ophthalmology. 2016;123(10):2103-2112. 2. Hoeh H, Vold SD, Ahmed IK, et al. Initial clinical experience with the CyPass Micro-Stent: Safety and surgical outcomes of a novel supraciliary microstent. J Glaucoma. 2016;25(1):106-112. Please see page 8 for Important Product Information. continued from page 3 CyPass Micro-Stent in the supraciliary space Fig. 1: Percentage of eyes achieving ≥20% reduction in unmedi- cated IOP at 24 months Fig. 2: Percentage of responders † that were medication-free at 24 months † Those patients who attained an unmedicated mean diurnal IOP reduction of 20% or more as compared with baseline in the absence of IOP-affecting surgery during the study 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% 24M **p=0.0011 72.5% of Eyes Achieved >20% Reduction in IOP at 2 years 28% more micro-stented eyes met IOP reduction goal 85% of micro-stented eyes required no medication at 2 years vs. 59% of controls Compass Trial Results: % of Patients on No Medications Percent of Eyes 72.5% ** 58.0% 40.0% 60.0% 80.0% 100.0% Percent of Patients 93.0% 72.4% +14.5% +20.6% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% 24M **p=0.0011 72.5% of Eyes Achieved >20% Reduction 28% more micro-stented eyes met IOP reduction goal 85% of micro-stented eyes required no medication at 2 years Compass Trial Results: % of Patients on Percent of Eyes 72.5% ** 58.0% 0.0% 20.0% 40.0% 60.0% 80.0% 100.0% 24M Percent of Patients 93.0% 72.4% +14.5% +20.6% IOP-lowering vs. cataract surgery by a TWO POINT DIFFERENCE required no medication at 2 years vs. 59% of controls Patients on No Medications Mean Diurnal IOP Reduction from Baseline CyPass ® Micro-Stent + Cataract surgery Cataract surgery Percent DiŽerence CyPass ® Micro-Stent + Cataract surgery (n=374) Cataract surgery (n=131) -5.3 32% Reduction in IOP at 2 years reduction goal Microstenting improved IOP-lowering vs. cataract surgery by a TWO POINT DIFFERENCE 85% of micro-stented eyes required no medication at 2 years vs. 59% of controls Compass Trial Results: % of Patients on No Medications Absolute Unmedicated Mean Diurnal IOP Reduction from Baseline target IOP range for 2 years IOP Range 6–18 mmHg CyPass ® Micro-Stent + Cataract surgery Cataract surgery Percent DiŽerence CyPass ® Micro-Stent + Cataract surgery (n=374) Cataract surgery (n=131) -7.0 ** -5.3 -12 -10 -8 -6 -4 -2 0 24M mmHg **p<0.0001 32% +32%