Table 2 Efficacy results of Hydrus Microstent studies
Publication | Study Design | N Eyes at Baseline | N Eyes at Follow-up | Glaucoma Type | Follow-up (months) | Baseline IOP Medicated (M) Washed-Out (W) | IOP (mmHg) at Follow-up (months) | Baseline Meds | Meds at Follow-up (Months) | Success / Failure Criteria | % Successful at (Months) | Reoperation Rate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
Gandolfi et al. 2016 [45] | Retrospective comparative case series | 21 Hydrus | 100% | 12 POAG 7 PXG 2 PDG | 24 | 24.0 ± 6.0 (M) | 15.0 ± 3.0 (24) | 3.1 ± 0.6 | 0.9 ± 0.9 (24) | To achieve post-surgery ‘target’ IOP (mid-high teens): Complete success = no meds Qualified success = some meds Failure = glaucoma surgery | Complete = 33.3% (24) Qualified = 57.1% (24) Failure = 9.5% (24) | 9.5% |
24 Canaloplasty | 100% | 16 POAG 8 PXG | 26.0 ± 4.0 (M) | 16.0 ± 2.0 (24) | 2.7 ± 0.8 | 0.7 ± 0.9 (24) | Complete = 50.0% (24) Qualified = 41.7% (24) Failure = 8.3% (24) | 8.3% | ||||
Fea et al. 2017 [46] | Retrospective case series | 92 Hydrus + Phaco | 80% (12 m) 73% (24 m) | 84 POAG 7 PXG 1 PDG | 24 | 19.4 ± 4.4 (M) | 15.5 ± 2.7 (12) 15.7 ± 2.5 (24) | 2.1 ± 1.0 | 0.6 ± 1.0 (12) 0.7 ± 1.0 (24) | 1) unmedicated IOP ≤18 2) unmedicated IOP ≤15 | 1) 70% (12) 1) 52% (24) 2) 36% (12) 2) 25% (24) | 0% (12 m) 1% (24 m) |
Fea et al. 2017 [51] | Prospective interventional comparative case series | 31 Hydrus | 97% | POAG | 12 | 23.1 ± 5.1 (M) | 16.5 ± 2.6 (12) | 2.29 ± 0.83 | 0.9 ± 1.04 (12) | Target IOP (mid-teens) maintained with no medication | 47% (12) | 0% |
25 SLT | 100% | POAG | 23.2 ± 2.2 (M) | 15.9 ± 2.5 (12) | 2.48 ± 0.92 | 2.0 ± 0.91 (12) | 4% (12) | 0% | ||||
Al-Mugheiry et al. 2017 [52] | Prospective observational cohort | 25 Hydrus + Phaco | 100% (12 m) | 21 POAG 2 NTG 2 PXG | 16.8 ± 5.6 (12–24) | 18.1 ± 3.6 (M) | 15.3 ± 2.2 (Last f/u) | 1.96 ± 0.96 | 0.04 ± 0.20 (Last f/u) | 1) unmedicated IOP < 21 2) unmedicated IOP < 18 3) unmedicated IOP < 15 | 1) 96% (Last f/u) 2) 80% (Last f/u) 3) 32% (Last f/u) | 0% |
Pfeiffer et al. 2015 [53] | Randomized Controlled Trial, single masked, multicentre | 50 Hydrus + Phaco | 96% (12 m) 96% (24 m) 92% W (12 m) 88% W (24 m) | 45 POAG 5 PXG | 24 | 18.9 ± 3.3 (M) 26.3 ± 4.4 (W) | 16–17 (12) (M) 16–17 (24) (M) 16.6 ± 2.8 (12) (W) 16.9 ± 3.3 (24) (W) | 2.0 ± 1.0 | 0.5 ± NR (12) 0.5 ± 1.0 (24) | ≥20% reduction in washed out diurnal IOP | 88% (12) 80% (24) | 0% (12 m) 2.1% (24 m) |
50 Phaco | 98% (12 m) 90% (24 m) 88% W (12 m) 68% W (24 m) | 41 POAG 8 PXG 1 PDG | 18.6 ± 3.8 (M) 26.6 ± 4.2 (W) | 16–17 (12) (M) 16–17 (24) (M) 17.4 ± 3.7 (12) (W) 19.2 ± 4.7 (24) (W) | 2.0 ± 1.1 | NR ± NR (12) 1.0 ± 1.0 (24) | 74% (12) 46% (24) | 0% (12 m) 4.1% (24 m) | ||||
Samuelson et al. 2019 [21] | Randomized Controlled Trial, single masked, multicentre | 369 Hydrus + Phaco | 95% | POAG | 24 | 17.9 ± 3.1 (M) 25.5 ± 3.0 (W) | 16.8 ± 3.2 (24) (M) 17.4 ± 3.7 (24) (W) | 1.7 ± 0.9 | 0.3 ± 0.8 (24) | ≥20% reduction in washed out diurnal IOP | 85.9% (12) 77.3% (24) | 0% |
187 Phaco | POAG | 18.1 ± 3.1 (M) 25.4 ± 2.9 (W) | 17.4 ± 3.0 (24) (M) 19.2 ± 3.8 (24) (W) | 1.7 ± 0.9 | 0.7 ± 0.9 (24) | 70.0% (12) 57.8% (24) | 2.1% | |||||
Ahmed et al. 2019 [56] | Randomized Controlled Trial, single masked, multicentre | 75 Hydrus | 97% 40% W | 72 POAG 3 PXG/PDG | 12 | 19.0 ± 3.9 (M) 27.5 ± 4.4 (W) | 17.3 ± 3.7 (24) (M) 21.5 ± NR (24) (W) | 2.5 ± 0.7 | 1.0 ± NR (24) | IOP ≤18, no meds, no secondary glaucoma surgery/ trabeculoplasty/cataract surgery | 35.6% (12) | 0 |
77, 2 iStents | 97% 31% W | 71 POAG 6 PXG/PDG | 19.1 ± 3.6 (M) 27.3 ± 4.2 (W) | 18.1 ± 3.7 (24) (M) 23.3 ± NR (24) (W) | 2.7 ± 0.8 | 1.7 ± NR (24) | 10.5% (12) | 2.6% |