Ashish Agar, Paul Healey, Graham Lee
Purpose: The SPECTRUM Global Registry provides high quality data for over 2900 eyes implanted with the Hydrus® Microstent in patients from 18 countries. This includes Standalone MIGS without concomitant cataract surgery, ie, a purely glaucoma procedure. We evaluated outcomes up to 5 years in eyes with primary open-angle glaucoma (POAG) and no prior glaucoma surgery, who underwent Hydrus implantation as standalone treatment.
Methods: Eligibility criteria were age >18 years, diagnosis of POAG, no prior incisional glaucoma surgery, Standalone and ≥ 6 months follow-up.
Results: A total of n 406 eyes of 353 patients were Hydrus microstent implantation, analysed with post-operative follow-up from 1 to 60 months. Mean intraocular pressure (IOP) (standard deviation) at baseline was 20.2 (6.1) mmHg, at 12 months (n=375) it was 16.1 (4.9) mmHg; at 36 months (n=149) 14.9 (3.8) mmHg, and at 60 months (n=53) mean IOP was 15.3 (3.9) mmHg, p < 0.0001 at every time point. Mean medications were 2.5 (1.2) per eye at baseline and remained significantly lower from 1 through 60 months (range 1.2-1.6 per eye, p < 0.005 at all time points), representing reductions of 0.7-1.5 medications per eye. The most common adverse events were IOP elevations of >10 mmHg above baseline (4.2%) and peripheral anterior synechiae formation (3.7%).
Conclusion: Standalone Hydrus Microstent implantation in eyes with POAG in the real-world clinical setting produces significant and lasting reductions from baseline in both mean IOP (29.1% at 12 months, 22.3% at 60 months) and the need for IOP-lowering medications, with an excellent safety profile and low rate of failure requiring additional surgery.