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Comparison of 1‐year outcomes of XEN implantation alone vs combined phacoemulsification‐XEN surgery at a Tertiary Center of Ophthalmology in Portugal
Abstract
Purpose: To compare the 1-year efficacy and safety of the XEN45 Stent (Allergan, Irvine, CA) implantation alone versus combined Xen implantation and phacoemulsification (Phaco-Xen) in patients with medically refractory open-angle glaucoma (mrOAG) at a tertiary center for Ophthalmology in Portugal, reporting the initial experience with XEN nationwide. Methods: Retrospective, comparative, interventional case series of 19 eyes (18 patients) with mrOAG who underwent XEN surgery (isolated or Phaco-Xen) at our institution with at least 12 months of follow-up post-implantation. Outcomes measured at 12-month follow-up included intra-ocular pressure (IOP) reduction and reduction rate (IOP-RR), number of IOP-lowering drugs, and complications. Success was defined as IOP-RR ≥ 20% and IOP < 18 mmHg and > 5 mmHg, with (qualified) or without (complete) need for IOP-lowering drugs, without further procedures for glaucoma including needling. Results: At 12-month post-XEN implantation, there was a statistically significant reduction in median IOP (5,0 mmHg, p-value = 0,050) in the isolated XEN group, but not in the Phaco-Xen group (median IOP reduction 8,0 mmHg, p-value = 0,123). Nevertheless, no statistically significant differences between both patient groups were observed in IOP-RR (p-value = 0,680) drug reduction (p-value = 0,056), number of successful cases (p-value = 0,605), and number of complications (p-value= 0,457). Conclusions: In our study, XEN45 implantation showed good efficacy in medically refractory OAG at 1 year. Combining cataract surgery showed neither added IOP-lowering benefit nor association with inferior success or increased number of complications. Larger, prospective studies are needed to ascertain whether cataract surgery may have an added IOP-lowering benefit in XEN surgery.
... 17 A comparative study showed no statistically significant differences in IOP reduction, eye drop reduction, success rates or number of complications between isolated implantation of XEN® Gel Stent (XEN) with or without cataract surgery. 20 However, the implantation of the PreserFlo™ MicroShunt combined with cataract surgery or as a standalone procedure was superior (absolute success: Group A: 80%, Group B: 60%; qualified success: Group A: 86.7%, Group B: 93.3% in our study) to XEN implantation (complete success: 57.7%; qualified success: 71.1%) at the end of a 12-month follow-up. 21 Based on previous studies, the mean decrease in ECD after trabeculectomy was between 9.3% and 24.6%, respectively. ...
Purpose:
To compare the efficacy and safety of PreserFlo™ MicroShunt (Santen, Osaka, Japan) combined with phacoemulsification to PreserFlo™ MicroShunt as a standalone procedure in eyes with moderate to advanced open-angle glaucoma.
Methods:
In an observatory, prospective, clinical study, 30 patients (30 eyes) with moderate to advanced angle glaucoma were allocated to either PreserFlo™ MicroShunt combined with phacoemulsification (15 eyes; Group A) or PreserFlo™ MicroShunt as a standalone procedure (15 eyes; Group B). The follow-up time of the study was 12 months.
Results:
Average intraocular pressure (IOP) at 12 months was 11.62 ± 1.6 mmHg in Group A and 13.8 ± 3.6 mmHg in Group B, which was significantly lower than baseline IOP (Group A: 23.47 ± 8.99 mmHg, P < 0.001; Group B: 23.4 ± 8.68 mmHg, P < 0.001). The absolute reduction of IOP within the 12 postoperative months was not significantly different between the two groups (P = 0.056). The number of the topical medications that were administered 12 months after ocular surgery was 0 in Group A and 0.6 ± 0.8 in Group B, compared to 3.13 ± 1.02 in Group A (P < 0.001) and 2.4 ± 1.45 in Group B (P = 0.004) at baseline. Phacoemulsification combined with PreserFlo™ MicroShunt significantly reduced the number of antiglaucoma agents after 12 months compared to the standalone procedure (P = 0.026). One eye in Group A was referred for bleb revision due to bleb fibrosis and a consequent acute postoperative rise in IOP. One eye in Group A required transscleral cyclophotocoagulation with MicroPulse® laser. One bleb revision was also necessary in Group B at the 4th postoperative week. Endothelial cell density did not significantly change over 12 months in either group (Group A: baseline, 2017.3 ± 346.8 cells/mm[2]; 12 months, 1968.5 ± 385.6 cells/mm[2]; P = 0.38; Group B: baseline, 2134.1 ± 382.6 cells/mm[2]; 12 months, 2094.4 ± 373.3 cells/mm[2], P = 0.42). The PreserFlo™ MicroShunt combined with phacoemulsification produced higher absolute success rates after 12 months in patients with moderate to advanced open-angle glaucoma than the PreserFlo™ MicroShunt as standalone procedure (Group A: 80% and Group B: 60%, P = 0.022).
Conclusions:
In eyes with moderate to advanced open-angle glaucoma, PreserFlo™ MicroShunt with or without phacoemulsification is effective in reducing IOP and the number of the antiglaucoma agents with a very small incidence of complications and subsequent glaucoma surgeries. However, adding phacoemulsification to PreserFlo™ MicroShunt successfully reduces IOP without the need for ongoing topical medications as are needed after the standalone procedure.
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