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Purpose
The FDA approved the Hydrus Microstent in August, 2018 for treatment of primary open angle glaucoma (POAG) in combination with cataract surgery. This paper presents the results of the first 75 commercial cases performed by an experienced surgeon on U.S. patients. Results are compared with those from the pivotal study.
Methods
Single surgeon, single site, retrospective chart review. The first 75 consecutive cases meeting eligibility criteria were reviewed by an independent observer. Outcomes measured include demographics, surgical parameters, IOP, number of hypotensive medications, and adverse events.
Results
Preliminary data consisting of 20 eyes from 13 patients were analyzed. Baseline mean IOP was 18.55 mmHg +/- 3.83 (SD) and mean number of glaucoma medications was 1.00 +/- 1.21. At 6 months mean IOP had dropped to 14.80 +/- 2.88 mmHg; P<0.01, and mean medications had reduced to 0.30 +/- 0.66; P<0.01. All Hydrus microstents were successfully implanted, with 100% success rate on the first attempt, and 100% were confirmed on gonioscopy to be properly positioned in Schlemm’s Canal at 1 week and 6 months postop. There were no cases of corneal edema or device migration. There were no persistent hyphema, iritis, IOP spike or any other adverse events beyond 1 month post-op.
Conclusion
Preliminary data suggest that the Hydrus Microstent was associated with clinically and statistically significant reduction in IOP and medication usage in the treatment of POAG.
The FDA approved the Hydrus Microstent in August, 2018 for treatment of primary open angle glaucoma (POAG) in combination with cataract surgery. This paper presents the results of the first 75 commercial cases performed by an experienced surgeon on U.S. patients. Results are compared with those from the pivotal study.
Methods
Single surgeon, single site, retrospective chart review. The first 75 consecutive cases meeting eligibility criteria were reviewed by an independent observer. Outcomes measured include demographics, surgical parameters, IOP, number of hypotensive medications, and adverse events.
Results
Preliminary data consisting of 20 eyes from 13 patients were analyzed. Baseline mean IOP was 18.55 mmHg +/- 3.83 (SD) and mean number of glaucoma medications was 1.00 +/- 1.21. At 6 months mean IOP had dropped to 14.80 +/- 2.88 mmHg; P<0.01, and mean medications had reduced to 0.30 +/- 0.66; P<0.01. All Hydrus microstents were successfully implanted, with 100% success rate on the first attempt, and 100% were confirmed on gonioscopy to be properly positioned in Schlemm’s Canal at 1 week and 6 months postop. There were no cases of corneal edema or device migration. There were no persistent hyphema, iritis, IOP spike or any other adverse events beyond 1 month post-op.
Conclusion
Preliminary data suggest that the Hydrus Microstent was associated with clinically and statistically significant reduction in IOP and medication usage in the treatment of POAG.
View More Presentations from this Session
This presentation is from the session "SPS-105 Minimally Invasive Glaucoma Surgery: Viscocanalostomy, Combined Procedures, Outcomes" from the 2020 ASCRS Virtual Annual Meeting held on May 16-17, 2020.