Clinical outcomes of Preserflo MicroShunt implant procedure in open‑angle glaucoma patients - a 1000 eyes case-series; including subanalysis of combined cataract-glaucoma surgery and standalone surgery in pseudophakic eyes.

PURPOSE

This retrospective, single-center study aimed to determine the long-term real-world efficacy and safety of the MicroShunt over up to a 6-year period in a heterogeneous glaucoma population of 1001 eyes: including pseudophakic eyes and eyes undergoing combined cataract and MicroShunt surgery.

METHODS

Data were analyzed from 1001 eyes implanted with the MicroShunt between January 2019 and May 2025. The outcomes collected were intraocular pressure (IOP) reduction, complete and qualified surgical success at targets of 6-14, 6-18, and 6-21 mmHg, the medication burden, and the postoperative complications. Subgroup analyses compared all the eyes implanted with pseudophakic eyes or those undergoing combined cataract and MicroShunt surgery.

RESULTS

The mean baseline IOP was 24.8 ± 8.4 mmHg across all eyes. IOP decreased to 9.6 ± 4.4 mmHg on postoperative day 1 and remained significantly reduced at 1 year (13.2 ± 3.9 mmHg) and 6 years (13.9 ± 2.3 mmHg). The IOP trajectories were similar in the subgroups. The IOP was slightly lower in eyes that had combined surgery. At 5 years, the complete success was 54%, 36%, and 8% for IOP thresholds of 6-21, 6-18, and 6-14 mmHg, respectively; while the qualified success rates were 62%, 38%, and 15%, respectively. The number of medications decreased significantly after surgery. Early postoperative complications were infrequent and usually transient. The complications were similar across subgroups with choroidal detachment (≤ 12%) and microhyphaema (10-15%) being the most common. Late complications occurred less often, and device-related failure leading to secondary glaucoma surgery rarely occurred (≤ 4%).

CONCLUSION

The MicroShunt provided a sustained reduction in IOP and medication burden with a low incidence of complications over the follow-up period. The outcomes in pseudophakic eyes and those undergoing combined cataract surgery were like the cumulative population. The inclusion of pseudophakic and combined surgery eyes reflects the real-world situation in glaucoma practice. These results build on mid-term evidence to support the reliability and safety of the MicroShunt.