Table 3.
Needling Results of Xen Studies
| Publication | Study Design | N Eyes at Baseline | N Eyes at Follow-Up (Months) | Glaucoma Type | Previous Intervention | Total Number and % of Needling/Revision | Type of Needling/Revision | Timing | No. of Repeated Needling | Complications |
|---|---|---|---|---|---|---|---|---|---|---|
| Pérez-Torregrosa et al 201623 | Prospective non-controlled and nonrandomized study | 30 Xen45+Phaco | 28 (12) | 30 PACG | - | 0 | - | - | - | - |
| Heidinger et al 201627 | Retrospective study | 61 Xen45 or 138 Xen45 + Phaco | 199 (12) | 113 POAG 72 PXG 11 OTHER 2 PACG 1 NTG |
89 (44.7%) TOT 61 (30.7%) glaucoma sx 45 (22.9%) cataract sx 13 (6.5%) other ocular sx |
44 (22.1%) | 44 (67.7%) FU 12 (18.5%) Dexamethasone 2 (3.1%) mechanic 7 (10.8%) YAG-laser |
6d–582d (med 59.5) at 1st needling | 25(12.6%) 1 needling 14 (7%) 2 needling 4 (2%) 3 needling 3 (1.5%) REVISION |
N/A |
| Hengerer et al 201725 | Retropspective analysis | 242 Xen45 or Xen45+Phaco | 148 (12) | 117 POAG 21 ACG 14 NVG 10 UVEITIC |
170 (70.2%) iStent 53 (21.9%) trab 35 (14.5%) cyclophoto 20 (8.3%) Phaco 10 (4.1%) laser |
41 (27.7%) | 27G+BSS (noMMC) | 1 w–3mo | N/A | N/A |
| Galal et al 201729 | Prospective interventional study | 13 Xen45 alone or Xen45+Phaco | 13 (12) | 13 POAG | None (criteria of exclusion) |
4 (30.7%) | 27G (noMMC) at slit lamp |
1mo (3eyes) 3mo (1eye) |
None | N/A |
| Ozal et al 201726 | Retrospective consecutive case series study | 15 Xen45 alone or Xen45+Phaco | 15 (12) | 10 POAG 4PXG 1PG |
3 (20%) | None | - | - | - | - |
| Grover et al 201722 | Prospective, single-arm, open-label, multicenter study | 65 Xen45 | 52 (12) | 57 POAG 6 PXG 1 PG 1 OTHER |
45 (69.2%) cataract sx 55 (84.6%) glaucoma sx |
21 (32.3%) | Mechanic removal of adhesions | N/A | 21 (32.3%) 1 needling 6 (9.2%) 2 needling 1 (1.5%) 3 needling |
N/A |
| Tan et al 201821 | Retrospective, consecutive, nonrandomized interventional case series | 39 Xn45 alone | 39(12) | 30 POAG 5 PXG 1 PG 4 UVEITIC 1 NVG 1 STEROID INDUCED |
12 (30.8%) phaco 3 (7.7%) trab 2 (5.13%) iStent |
20 (51.3%) | FU at slit lamp | 1w–5mo | 2 (1–4) | None |
| Widder et al 201816 |
Retrospective single-center study | 233 Xen45 alone or Xen45+Phaco | 233 (8.5) | 180 POAG 2 PG 44 PXG 1 JOAG 6 SEC GL |
17 (7.3%) trab 6 (2.6%) deep scl 39 (16.7%) ALT/SLT 31 (13.3%) trabectome 6 (2.6%) vtc |
80 (34%) 1 revision | Revisional surgery | N/A | 23 (10%) | - |
| Mansouri et al 201830 | Prospective interventional study | 40 Xen 45 alone | 87 (12) | 15 POAG 10 PXG 4 OTHER |
N/A | 18 (45%) | 27G+MMC 0.01% | 158d | N/A | 3 (2%) Xen damage |
| 109 Xen45+Phaco | 61 POAG 42 PXG 10 OTHER |
37 (34%) | 126d | |||||||
| Hohberger et al 201831 | Monocentric prospective interventional study | 81 Xen45 alone | 81(6) | 72 POAG 31 PXG 8 OTHER |
N/A | 49.4% | 27G+Bevacizumab 1.00mg | N/A | N/A | N/A |
| 30 Xen45+Phaco | 30 (6) | 46.7% | ||||||||
| De Gregorio et al 201824 |
Nonrandomized prospective | 41 Xen45 + Phaco | 40 (12) | 35 POAG 6 PXG |
1 (2.5%) deep sclerectomy | 1 (2.5%))needling | N/A | N/A | N/A | N/A |
| Karimi et al 201928 | Retrospective review | 187 Xen45 or 72 Xen45+ Phaco | 259 (12) | 208 POAG 17 NTG 13 PXG 6 PG 6 TRAUMA 5 NVG 1 IATROGENIC 3 OTHER |
72 (34.4%) SLT 11 (4.2%) trab 7 (3.3%) valve/stent |
(40.9%) | 30G needle 12 (4.6%) physical 35 (13.5%) pharmacological: 8.5% MMC, 91.5% 5FU 58 (22.45) both |
1–3mo | Mean 1.6 per case | N/A |
| Midha et al 201950 | Report | 40 Xen45 | 149 (12) | POAG 15 PEXG 10 |
Criteria of exclusion | 18 (45%) Efficacy 81% at 1 yr |
N/A | 1.15 OR at d1 1.16 OR at w1 |
36 (24.2%) 1 needling 14 (9.4%) 2 needling 5 (3.4%) 3 needling |
IOP at d1 >20 mm Hg -> 80% prob of needling >10 mm Hg ->35% prob |
| 109 Xen45 + Phaco | POAG 46 PXG 32 |
37 (34%) Efficacy 56.1% at 1 yr |
1.01 OR at d1 1.03 OR at w1 |
|||||||
| Reitsamer et al 201932 | Prospective multicenter nonrandomized trial | 120 Xen45 or 98 Xen45 + Phaco | 202 (24) | POAG | Exclusion criteria | 50 (43.9%) | 74 (89.2%) antifibrotic agent (MMF, %FU, other) | Mean time to 1st needling 152d | 56 (67.5%) 1 needling IOP ≥20%: 59.2% at 12 mo 44.6% at 24mo |
N/A |
| 33 (37.5%) | ||||||||||
| Fea et al 202033 | Prospective multicenter | 115 Xen45 or 56 Xen+Phaco | 149 (12) | 134 POAG 27 PXG 2 JOAG 7 NTG 3 UVG 1 OHT 2 Mixed |
4 (2.3%) trab 1 (0.6%) deep sclerectomy 1 (0.6%) vtc 1 (0.6%) buckling 47 (27.5%) SLT 1 (0.6%) ALT |
79 (46.2%) needling 1 (0.7%) stent revision for exposure Efficacy: 41 (27.5%) |
N/A | N/A | 41 (27.5%) 1 needling 21 (14%) 2 needling 10 (6.7%) 3 needling 3 (2%) 4 needling 2 (1.3%) 5 needling 2 (1.3%) 6 needling |
1 (0.6%) perforation after needling |
Abbreviations: POAG, primary open-angle glaucoma; PEXG, presudoexfoliative glaucoma; JOAG, juvenile open angle glaucoma; PACG, angle closure glaucoma; PG, pigmentary glaucoma; NTG, normal tension glaucoma; UVG, uveitic glaucoma; NVG, neovascular glaucoma; OHT, ocular hypertenision; IOP, intraocular pressure; FU, follow-up; trab, trabeculectomy; vtc, vitrectomy; SLT, selective laser trabeculoplasty; ALT, argon laser trabeculoplasty; prob, probability; ciclophoto, cuclophotocoagulation; sx, surgery; FU, follow-up; MMC, mitomycin; d, day; w, week; mo, month; yr, year.