Comparative Effectiveness and Safety of Two Different Trabecular MIGS Devices With and Without Ab Interno Canaloplasty in Patients with Primary Open-Angle Glaucoma.

INTRODUCTION: This study compared outcomes of the iStent inject trabecular micro-bypass system versus the Hydrus Microstent in patients with primary open-angle glaucoma (POAG). METHODS: Forty subjects (80 eyes) with POAG were included in this single-center, retrospective, contralateral-eye analysis. All patients underwent phacoemulsification with either iStent inject or Hydrus implantation in one eye and the other device in the contralateral eye, with ≥ 3-month follow-up. In 58 eyes (27 iStent inject, 31 Hydrus) the surgery also included ab interno canaloplasty (ABiC). Twelve-month outcomes included intraocular pressure (IOP), medications, and adverse events. Subgroup analyses were completed for iStent inject versus Hydrus, and with versus without ABiC. RESULTS: At 12 months versus baseline, mean IOP reduced from 16.8 ± 3.7 to 13.6 ± 2.9 (p = 0.003) in iStent inject eyes, and from 18.1 ± 4.5 to 14.9 ± 3.2 mmHg (p = 0.003) in Hydrus eyes (between-group IOP reduction p = 0.582). Mean number of glaucoma medications reduced from 1.23 ± 0.97 to 0.30 ± 0.76 (p < 0.001) in iStent inject eyes and from 1.20 ± 1.02 to 0.39 ± 0.72 (p = 0.001) in Hydrus eyes (between-group medication reduction p = 0.943). At 12 months, 82.6% of iStent inject eyes and 73.9% of Hydrus eyes were medication-free versus 20.0% preoperatively in both groups (p < 0.0001 both groups). There were no statistically significant IOP or medication differences between iStent inject and Hydrus pre- or postoperatively, both in the overall cohort and in the with/without ABiC subgroups. Outcomes also were similar between eyes with/without ABiC in the overall cohort and in the iStent inject/Hydrus subgroups. There were no adverse events in the iStent inject group; two eyes in the Hydrus group had device-related complications requiring five additional surgeries (one Hydrus repositioning, one Hydrus exchange, one Hydrus removal, two goniotomies). CONCLUSION: In this contralateral-eye comparison of iStent inject versus Hydrus, the groups had similar IOP and medication outcomes, regardless of stratification by ABiC completion. Eyes receiving Hydrus had more complications and subsequent surgeries.

The present study contributes some of the first real-world data comparing iStent inject versus Hydrus Microstent implantation in combination with cataract surgery in opposite eyes (right or left) of the same patient (i.e., contralateral-eye study). The report also includes subgroup analyses of eyes with versus without ab interno canaloplasty (ABiC). There were no significant between-group differences in mean intraocular pressure or medication burden preoperatively or postoperatively for iStent inject versus Hydrus. The intraocular pressure and medication reductions versus the groups' respective baselines were statistically similar as well. Finally, results remained similar for iStent inject versus Hydrus regardless of whether ABiC was completed, and were also similar when comparing eyes with ABiC versus without ABiC. In eyes receiving Hydrus, there was a greater incidence of complications and need for further surgery.

Safety and effectiveness comparison of a new cohesive ophthalmic viscosurgical device.

PURPOSE: To evaluate the safety and effectiveness of a new cohesive ophthalmic viscosurgical device (OVD) (StableVisc) compared with a marketed cohesive OVD (ProVisc) in patients undergoing cataract surgery. SETTING: 22 sites in the United States. DESIGN: Prospective multicenter controlled double-masked and randomized 1:1 (StableVisc:ProVisc; stratified by site, age group, and cataract severity). METHODS: Adults (≥45 years) with age-related noncomplicated cataract considered amenable to treatment with standard phacoemulsification cataract extraction and intraocular lens implantation were included. Patients were randomized to receive either StableVisc or ProVisc during standard cataract surgery. Postoperative visits occurred at 6 hours, 24 hours, 7 days, 1 month, and 3 months. The primary effectiveness outcome was the change in endothelial cell density (ECD) from baseline to 3 months. The primary safety endpoint was the proportion of patients who experienced at least 1 intraocular pressure (IOP) measurement ≥30 mm Hg at any follow-up visit. Noninferiority between the devices was tested. Inflammation and adverse events were evaluated. RESULTS: 390 patients were randomized; 187 patients with StableVisc and 193 patients with ProVisc completed the study. StableVisc was noninferior to ProVisc in mean ECD loss from baseline to 3 months (17.5% and 16.9%, respectively). StableVisc was noninferior to ProVisc in the proportion of patients with postoperative IOP ≥30 mm Hg at any follow-up visit (5.2% and 8.2%, respectively). CONCLUSIONS: The StableVisc cohesive OVD, which provides both mechanical and chemical protection, was safe and effective when used in cataract surgery and provides surgeons with a new cohesive OVD.