Mid-term real world outcomes of the HydrusMicrostent in open angle glaucoma.

PURPOSE

To evaluate the mid-term clinical results and the safety aspects of the HydrusMicrostent (Ivantis, Inc, Irvine, CA) in a real-life setting.

DESIGN

Retrospective case series.

METHODS

HydrusMicrostent was implanted in phakic eyes (88 eyes, 87.1%) and in pseudophakic eyes (13 eyes, 12.9%), respectively. Mean follow-up time was 16 ± 9 months with 27 eyes having a follow-up time of more than 24 months.

MAIN OUTCOME MEASURES

The primary endpoint was reduction in IOP compared to baseline. Target IOP levels were set at ≤20 mmHg, ≤18 mmHg and ≤15 mmHg. Kaplan-Meier survival was defined as a reduction in IOP of ≥20% compared to baseline. Secondary endpoints were reduction in number of glaucoma medications and safety assessments addressing visual acuity, adverse events, re-surgery rate and identification of factors that made the implantation more difficult.

RESULT

101 eyes underwent Hydrusimplantation. The mean preoperative IOP was 21.60 mmHg (SD 6.6) on 2.18 (SD 1.3) medications. After a mean follow up time of 16 months, the mean IOP was reduced to 14.61 ± 3.7 mmHg on 1.12 (SD 1.1) medication classes (p < 0.001). Mean decrease in IOP was 26.7%. Analysis of the target IOP levels showed that in 29%, 34% and 35% of cases an IOP of ≤15 mmHg, ≤18 mmHg and ≤20 mmHg respectively could be achieved. BCVA improved from 0.56 ± 0.3 at baseline to 0.85 ± 0.3 more than 24 months after surgery (p < 0.001). The rate of re-operation was low at <3%. Adverse events occurred in 4 eyes (<4%).

CONCLUSION

This study underlines the effectiveness and the safety of the HydrusMicrostent in an elective setting, but it also demonstrates certain limits and risk factors of this procedure.