Table 1.
Outcomes of published studies for MIGS devices
| Author (year of study) | Study design (N at baseline)a | Baseline mean IOP → final IOP at follow-up (unless results otherwise stated) (P-value) | Baseline mean number of medications → final mean number of medications (unless results otherwise stated) | % IOP reductionb and % medication reductionb,c |
|---|---|---|---|---|
| Trabectome alone | ||||
| Minckler et al9 (2005) | Consecutive case series (37) | 28.2±4.4 mmHg → 17.4±3.5 mmHg at 6 months (no P-value) | 1.2±0.6 → 0.4±0.6 | 38% IOP reduction |
| Minckler et al12 (2006) | Consecutive case series (101) | 27.6±7.2 mmHg → 16.3±3.3 mmHg at 30 months (P<0.0001) | n/a | 41% IOP reduction |
| Minckler et al10 (2008) | Case series (738) | 25.7±7.7 mmHg → 16.6±4.0 mmHg at 24 months (no P-value) | 2.93 → 1.2 | 35% IOP reduction |
| Ting et al15 (2012) | Consecutive case series (517) | 29.0±7.5 mmHg → 16.1±4.0 mmHg in the PXG group at 1 year; 25.5±7.9 mmHg → 16.8±3.9 mmHg in the POAG group at 1 year (P<0.01 between PXG and POAG outcomes) | 3.09±1.15 → 2.21±1.38 in PXG; 2.73±1.33 → 2.16±1.29 in POAG | 44% IOP reduction with 28% medication reduction in PXG; 34% IOP reduction and 21% medication reduction in POAG |
| Ahuja et al17 (2013) | Consecutive case series (88) | 25.9±8.9 mmHg → 16.8±2.8 mmHg at 24 months (P<0.001) | 3.3±1.1 → 2.2±1.5 (P=0.07) | 35% IOP reduction |
| Maeda et al13 (2013) | Consecutive case series (80) | 26.6±8.1 mmHg → 17.4±3.4 mmHg at 6 months (P<0.05) | 4.0±1.4 → 2.3±1.2 (P<0.05) | 29% IOP reduction |
| Trabectome with CE/IOL | ||||
| Francis et al14 (2008) | Consecutive case series (304) | 20.0±6.3 mmHg → 15.5±2.9 mmHg at 1 year (no P-value) | 2.7±1.1 → 1.4±1.3 | 16% IOP reduction |
| Minckler et al10 (2008) | Consecutive case series (366) | 20.0±6.2 mmHg → 15.9±3.3 mmHg at 12 months (no P-value) | 2.63±1.12 → 1.50±1.36 | 18% IOP reduction |
| Ting et al15 (2012) | Consecutive case series (308) | 21.7±8.4 mmHg → 14.2±3.2 mmHg in the PXG group at 1 year; 19.9±5.4 mmHg → 15.6±3.2 mmHg in the POAG group at 1 year (P<0.01 between PXG and POAG outcomes) | 2.53±0.99 →1.57±1.33 in PXG; 2.4±1.08 → 1.65±1.3 in POAG | 35% IOP reduction with 38% medication reduction in PXG; 22% IOP reduction and 31% medication reduction in POAG |
| Ahuja et al17 (2013) | Consecutive case series (158) | 19.3±7.4 mmHg → 14.9±4.9 mmHg at 24 months (P=0.10) | 3.0±1.1 → 1.8±1.3 (P<0.001) | 22.8% IOP reduction |
| Trabectome with or without CE/IOL | ||||
| Jordan et al18 (2013) | Consecutive case series (261 POAG, 173 PXG) | POAG: 24.5±5.5 mmHg → 18±6.1 mmHg at 204 days (no P-value) | 2.1±1.3 → 1.2±1.1 | 26% IOP reduction with 43% medication reduction |
| PXG: 25±5.9 mmHg → 18±8.2 mmHg at 200 days (no P-value) | 2.0±1.2 → 1.1±1.1 | 28% IOP reduction with 45% medication reduction | ||
| iStent with CE/IOL | ||||
| Fea25 (2010) | Double-masked RCT (36) | Baseline IOP was 17.9±2.6 mmHg in the stent/CE/IOL group and 17.3±3.0 mmHg in the CE/IOL group. IOP at 15 months: 14.8±1.2 mmHg in stent/CE/IOL and 15.7±1.1 mmHg in CE/IOL. Final IOP after washout at 16 months: 16.6±3.1 mmHg in the stent/CE/IOL group compared to 19.2±3.5 mmHg in the CE/IOL group (P=0.042) | Baseline: 2.0±0.9 in stent/CE/IOL and 1.9±0.7 in CE/IOL. At 15 months: 0.4±0.7 in stent/CE/IOL and 1.3±1.0 in CE/IOL | 17.3% IOP reduction with 80% medication reduction in the stent/CE/IOL group (9.2% IOP reduction and 31.6% medication reduction in the CE/IOL group) |
| Samuelson et al26 (2011) | Multicenter RCT (240) | Baseline IOP was 18.7±3.3 mmHg on medications in the stent/CE/IOL group and 18.0±3.0 mmHg in the CE/IOL group (25.2±3.5 mmHg in stent/CE/IOL and 25.5±3.7 mmHg in CE/IOL after washout). Final IOP in each group at 12 months not reported, but mean reduction (treated) from treated baseline was 1.5±3.0 mmHg in the stent/CE/IOL group and 1.0±3.3 mmHg in the CE/IOL group (P-value not reported). 66% of the stent/CE/IOL group, compared to 48% of the CE/IOL group, had ≥20% IOP reduction without medication at 1 year (P=0.003) | Baseline: 1.5±0.7 in stent/CE/IOL and 1.5±0.6 in CE/IOL. At 12 months: 0.2±0.6 in stent/CE/IOL and 0.4±0.7 in CE/IOL (P=0.016) | 8% IOP reduction with 87% medication reduction in the stent/CE/IOL group (5.5% IOP reduction and 73% medication reduction in the CE/IOL group) |
| Craven et al27 (2012) | Multicenter RCT (240) | Baseline IOP on medications was 18.6±3.4 mmHg in the stent/CE/IOL group and 17.9±3.0 mmHg in the CE/IOL group (25.4±3.5 mmHg in stent/CE/IOL and 25.2±3.6 mmHg in CE/IOL after washout). At 12 months, treated IOP was 17.0±2.8 in stent/CE/IOL and 17.0±3.1 mmHg in CE/IOL (P-value not reported). 53% of the stent/CE/IOL group, compared to 44% of the CE/IOL group, had ≥20% IOP reduction without medication at 1 year (P=0.090) | Baseline: 1.6±0.8 in stent/CE/IOL and 1.5±0.6 in CE/IOL. At 12 months: 0.2±0.6 in stent/CE/IOL and 0.4±0.7 in CE/IOL | 8.6% IOP reduction with 88% medication reduction in the stent/CE/IOL group (5.0% IOP reduction and 73% medication reduction in the CE/IOL group) |
| Multiple iStents with CE/IOL | ||||
| Fernández-Barrientos et al28 (2010) (two iStents) | RCT (33) | Baseline IOP was 24.2±1.8 mmHg in the two-stent/CE/IOL group and 23.6±1.5 mmHg in the CE/IOL group. Final IOP was 17.6±2.8 mmHg in the two-stent/CE/IOL group compared to 19.8±2.3 mmHg in the CE/IOL group at 12 months (P=0.04) | Baseline: 1.1±0.5 in stent/CE/IOL and 1.2±0.7 in CE/IOL. At 12 months: 0.1±0.5 in stent/CE/IOL and 0.7±1.0 in CE/IOL (P=0.007) | 27% IOP reduction with 91% medication reduction in two-stent/CE/IOL (16% IOP reduction with 42% medication reduction in CE/IOL) |
| Belovay et al29 (2012) (two vs three iStents) | Consecutive case series (53) | Baseline IOP was 17.3±4.0 mmHg in the two-stent/CE/IOL group and 18.6±4.0 mmHg in the three-stent/CE/IOL group. Final IOP was 13.8 mmHg in the two-stent/CE/IOL group (P<0.001) and 14.8 mmHg in the three-stent/CE/IOL group (P<0.001) at 1 year (P=0.78 between the two groups at 12 months). 83% of eyes overall had a decrease in number of medications | Baseline: 2.8±0.8 in two-stent/CE/IOL and 2.6±1.2 in three-stent/CE/IOL. At 12 months: 1.0 in two-stent/CE/IOL (P<0.001) and 0.4 in three-stent/CE/IOL (P<0.001) (P=0.4 between the two groups) | 20% IOP reduction with 64% medication reduction in the two-stent/CE/IOL group, vs 20% IOP reduction with 85% medication reduction in three-stent/CE/IOL |
| Multiple iStents (second-generation iStent inject) alone | ||||
| Voskanyan et al22 (2014) | Consecutive case series (99 phakic and pseudophakic) | 22.1±3.3 mmHg (baseline washed-out 26.3±3.5 mmHg) → 15.7±3.7 mmHg at 12 months (no P-value). 66% had IOP ≤18 mmHg off of medication; 72% had ≥20% IOP reduction without medication at 12 months | 2.21 medications at baseline. Data about medications at 12 months were not provided. 86.9% had reduction in medication burden, with 15.7% reduced by one medicine and 71.7% reduced by two or more medicines | 29% IOP reduction from medicated baseline data on follow-up medication not specified |
| Fea et al30 (2014) | RCT of two stents vs two medications | Baseline washed-out IOP: 25.2±1.4 mmHg in the two-stent group vs 24.8±1.7 mmHg in the two-medications group. Final IOP: 13.0±2.3 mmHg in the two-stent group vs 13.2±2.0 mmHg in the two-medications group at 12 months (P=0.02). 94.7% of the two-stent group and 91.8% of the two-medications group achieved an IOP reduction of ≥20% | 48% IOP reduction in the two-stent group (47% in the two-medications group) | |
| Klamann et al31 (2015) | Consecutive case series (35) | Baseline IOP: 21.19±2.56 mmHg in POAG; 23.75±3.28 mmHg in PXG; 28.31±3.21 mmHg in PG. At 6 months: 14.19±1.38 mmHg in POAG (P<0.001), 15.33±1.07 mmHg in PXG (P<0.001). The three phakic PG patients had IOP spikes to >30 mmHg and underwent trabeculectomy | Baseline: 2.19±0.91 in POAG, 2.33±1.23 in PXG, and 3.66±0.57 in PG. At 6 months: 0.88±0.62 in POAG, 1.04±0.30 in PXG, and all PG needed trabeculectomy at 6 months | 33% IOP reduction with 60% medication reduction in POAG (P<0.001); 35% IOP reduction with 55% medication reduction in PXG (P<0.001) |
| Hydrus with CE/IOL | ||||
| Pfeiffer et al33 (2015) | Single-masked, multicenter RCT (100) | Baseline IOP: 18.9±3.3 mmHg in the Hydrus/CE/IOL group and 18.6±3.8 mmHg in the CE/IOL group. Washed-out baseline: 26.3±4.4 mmHg in Hydrus/CE/IOL and 26.6±4.2 mmHg in CE/IOL. Final washed-out: 16.9±3.3 in Hydrus/CE/IOL and 19.2±4.7 mmHg at 24 months (P=0.0093). 80% of Hydrus patients had ≥20% reduction in washed-out IOP compared to 46% of patients undergoing cataract surgery alone (P=0.0008) | Baseline: 2.0±1.0 in Hydrus/CE/IOL and 2.0±1.1 in CE/IOL. At 24 months: 0.5±1.0 in the Hydrus/CE/IOL group compared with 1.0±1.0 in the CE/IOL group (P=0.0189) | After washout: 50% IOP reduction in Hydrus/CE/IOL (28% IOP reduction in CE/IOL) |
| GATT with/without CE/IOL | ||||
| Grover et al34 (2014) | Consecutive case series (85 OAG) | Baseline IOP: 25.6 mmHg in the GATT (phakic) group, 23.9 mmHg in the GATT/CE/IOL group, and 23.8 mmHg in the GATT (pseudophakic) group. At 1 year: 15.7, 15.5, and 16.2 mmHg, respectively, in each group (P<0.001 overall) | Baseline: 3.2±0.9 in GATT (phakic), 2.9±1.1 in GATT/CE/IOL, 2.2±1.0 in GATT (pseudophakic). At 1 year: 1.5±1.2, 1.0±1.4, 2.6±1.5, respectively, in each group (P<0.001 overall) | 39% IOP reduction with 53% medication reduction in the GATT-only (phakic) group; 35% IOP reduction with 48% medication reduction in the GATT/CE/IOL group |
| ELT alone | ||||
| Babighian et al39 (2010) | RCT with SLT as control (30) | Baseline IOP: 25.0±1.9 mmHg in the ELT group and 23.9±0.9 mmHg in the SLT group. At 24 months: 17.6±2.2 mmHg (P<0.0001) in the ELT group and 19.1±1.8 mmHg (P<0.0001) in the SLT group. 53.5% of the ELT group, compared to 40% of the SLT group, had ≥20% IOP reduction at 24 months (P=0.35) | Baseline: 2.27±0.7 in the ELT group and 2.20±0.7 in the SLT group. At 24 months: 0.87±0.8 in the ELT group and 0.87±0.8 in the SLT group | 30% IOP reduction with 62% medication reduction in ELT (21% IOP reduction and 60% medication reduction in the SLT group) |
| Töteberg-Harms et al40 (2013) | Consecutive comparative case series (28) | Overall baseline IOP was 19.8±5.3 mmHg, and IOP was reduced by 4.5±5.9 mmHg at 12 months. IOP reduction was substantially greater in those with higher baseline IOP | Medications reduced by 0.79±1.5 at 12 months | 23% IOP reduction (P<0.001) with 38.9% medication reduction (P<0.001) |
| Cypass alone | ||||
| García-Feijoo et al45 (2015) | Consecutive case series (65) | 24.5±2.8 mmHg → 16.4±5.5 mmHg at 12 months (P<0.0001) | 2.2±1.1 → 1.4±1.3 | 35% IOP reduction with 36% medication reduction |
| Cypass with CE/IOL | ||||
| Hoeh et al44 (2013) | Consecutive case series (184) | Baseline IOP: 21.1±5.91 mmHg overall. At 6 months: 15.6±0.53 mmHg in the IOP-uncontrolled group (P<0.001) and 15.6±0.68 mmHg in the IOP-controlled group (P<0.001) | Baseline: 2.1±1.1. Final medication amount not specified | Patients with medicated baseline IOP ≥21 mmHg had a 37% IOP reduction and a 50% medication reduction. IOP–controlled patients had a 71% medication reduction (P<0.001) |
| ECP with CE/IOL | ||||
| Francis et al46 (2014) | Consecutive matched-control series (88) | Baseline IOP: 18.1±3.0 mmHg in the ECP/CE/IOL group and 18±3.0 mmHg in the CE/IOL group. At 2 years: 16.0±3.3 mmHg in the ECP/CE/IOL group and 17.3±2.3 mmHg in the CE/IOL group (P=0.01) | Baseline: 1.5±0.8 in ECP/CE/IOL and 2.4±1.0 in CE/IOL. At 2 years: 0.4±0.7 in ECP/CE/IOL and 2.0±1.0 in CE/IOL (P<0.01) | 10% IOP reduction with 73% medication reduction in the ECP/CE/IOL group (0.8% IOP reduction and 17% medication reduction in CE/IOL) |
| Siegel et al47 (2015) | Consecutive case series (261) | Baseline IOP: 17.2±4.8 mmHg in the ECP/CE/IOL group and 17.7±4.4 mmHg in the CE/IOL group. At 36 months: 14.7±3.1 mmHg in ECP/CE/IOL and 15.5±3.6 mmHg in CE/IOL (P=0.34) | Baseline: 1.3±0.6 in ECP/CE/IOL and 1.5±0.7 in CE/IOL. At 36 months: 0.2±0.6 in ECP/CE/IOL and 1.3±0.6 in CE/IOL (P<0.001) | 14.5% IOP reduction with 85% medication reduction |
| XEN gel stent | ||||
| No trials published to date |
Notes: This table summarizes the main IOP outcomes of each study for a MIGS device. This format is limited by the variation in study design.
a
RCTs had cataract surgery alone as control group, unless otherwise specified.
b
When not stated in the cited paper, we calculated this as % reduction of average final from average baseline. cSpecified when the necessary data were provided.
Abbreviations: CE/IOL, cataract extraction/intraocular lens implant; ECP, endocyclophotocoagulation; ELT, excimer laser trabeculotomy; GATT, gonioscopy-assisted transluminal trabeculotomy; IOP, intraocular pressure; MIGS, minimally invasive glaucoma surgery; n/a, not available; OAG, open-angle glaucoma; PG, pigmentary glaucoma; POAG, primary open-angle glaucoma; PXG, pseudoexfoliation glaucoma; RCT, randomized controlled trial; SLT, selective laser trabeculoplasty.