Evaluation of a Schlemm canal scaffold microstent combined with phacoemulsification in routine clinical practice: Two-year multicenter study.

PURPOSE: To evaluate the efficacy and the safety of a new Schlemm canal scaffold microstent (Hydrus) combined with cataract surgery in routine clinical practice.

SETTINGS: Clinics in Italy, Poland, and the United Kingdom.

DESIGN

Retrospective case series.

METHODS

Clinical outcomes in patients with primary open-angle glaucoma who had combined phacoemulsification and microstent implantation were analyzed. Data (intraocular pressure [IOP], number of glaucoma medications, incidence of complications) were collected preoperatively and postoperatively through 24 months.

RESULTS

Ninety-two eyes were included. Six patients had previous glaucoma surgeries. Sixty-seven patients completed a 2-year follow-up. The mean baseline IOP was 19.4 mm Hg ± 4.4 (SD). The mean IOP was 15.5 ± 2.7 mm Hg at 1 year and 15.7 ± 2.5 mm Hg at 2 years (P < .001). The IOP reduction was correlated with the baseline IOP (R2 = 0.72). The mean number of glaucoma medications was 2.1 ± 1.0 preoperatively, decreasing significantly at 1 year (0.6 ± 1.0) and 2 years (0.7 ± 1.0) (P < .001). At 2 years, 64% of patients were medication free. In patients with an IOP of 18 mm Hg or higher preoperatively, the reduction in IOP and in the number of medications was higher. Two patients required microstent repositioning intraoperatively. One patient was treated with an argon laser for microstent obstruction, and 1 patient had a trabeculectomy at 18 months.

CONCLUSION

This microstent combined with cataract surgery safely and effectively reduced the IOP and medication use in a routine clinical practice setting with results comparable to those in previously published controlled clinical trials.