Effectiveness and safety of XEN63 in patients with primary-open-angle glaucoma.

This paper evaluates the effectiveness and safety of XEN63 stent, either standalone or in combination with phacoemulsification, in patients with primary open-angle glaucoma (POAG). Eighty eyes from 80 patients with medically uncontrolled POAG were assigned to undergo XEN63 implant. The primary outcome was the surgical success, defined as an intraocular pressure (IOP) lowering from preoperative values ≥ 20% and an IOP absolute value between 6 and 18 mmHg, with or without antiglaucoma medications. Forty-three (53.7%) eyes underwent XEN63-standalone and 37(46.2%) eyes a XEN63 + Phacoemulsification procedure. Success rate was 68.8% (55/80) eyes in the overall study sample, 69.8% (30/43) eyes in the XEN63-standalone group; and 67.6% (25/37) eyes in the XEN63 + Phaco group (p = 0.6133). Preoperative IOP was significantly lowered from 22.1 ± 4.9 mmHg and 19.8 ± 3.7 mmHg to 14.7 ± 5.3 mmHg and 13.8 ± 3.4 mmHg in the XEN63-standalone and XEN63 + Phaco groups, respectively (p < 0.0001 each, respectively); without significant differences between them at any of the time-points measured. Preoperative number of ocular-hypotensive drugs was significantly reduced from 2.3 ± 0.8 to 0.3 ± 0.7 drugs, from 2.5 ± 0.7 to 0.3 ± 0.7 drugs; and from 2.0 ± 0.8 to 0.3 ± 0.7 drugs, in the overall, XEN63-standalone, and XEN63 + Phaco groups, respectively. Regarding safety, 3(42.5%) eyes had transient hypotony at some point during the study, although only in one (1.2%) eye was clinically significant. Four (5.0%) eyes underwent a needling, 4 (5.0%) eyes underwent surgical-bleb-revision, 1 (1.2%) eye required a device replacement and 1 (1.2%) eye a device removal due to maculopathy. XEN63, either alone or in combination with phacoemulsification, significantly lowered IOP and reduced the number of ocular hypotensive medications. The rate of ocular hypotony was relatively high, although it was clinically relevant only in one eye.

Long-Term Effectiveness of XEN 45 Gel-Stent in Open-Angle Glaucoma Patients.

Purpose: To assess the effectiveness of XEN45, either alone or in combination with phacoemulsification, in open-angle glaucoma (OAG) patients in clinical practice. Methods: Retrospective and single-center study conducted on OAG patients who underwent XEN45 implant, either alone or in combination with cataract surgery. We compared the clinical outcomes of the eyes of thosewho underwent XEN-solo versus those who underwent XEN+Phacoemulsification. The primary endpoint was the mean change in intraocular pressure (IOP) from baseline to the last follow-up visit. Results: A total of 154 eyes, 37 (24.0%) eyes that underwent XEN-solo and 117 (76.0%) eyes that underwent XEN+Phacoemulsification, were included. The mean preoperative IOP was significantly lowered from 19.1±5.0 mmHg to 14.9±3.8 mmHg at month-36, p<0.0001. Preoperative IOP was significantly lowered from 21.2±6.2 mmHg and 18.4±4.3 mmHg to 14.3±4.0 mm Hg and 15.2±3.7 mmHg at month-36 in the XEN-solo and XEN+Phacoemulsification groups, p<0.0004 and p=0.0009; with no significant differences between them. In the overall study population, the mean number of antiglaucoma medications was significantly reduced from 2.1±0.8 to 0.2±0.6, p<0.0001. There were no significant differences in the proportion of eyes with a final IOP ≤14 mmHg and ≤16 mmHg between XEN-solo and XEN+Phaco groups (p=0.8406 and 0.04970, respectively). Thirty-six (23.4%) eyes required a needling procedure. Conclusion: XEN implant significantly lowered IOP and reduced the need of ocular hypotensive medication, while maintaining a good safety profile. Beyond week-1, there were no significant differences in IOP lowering between XEN-solo and XEN+Phacoemulsification groups.

3-Year Outcomes of XEN Implant Compared With Trabeculectomy, With or Without Phacoemulsification for Open Angle Glaucoma.

PRCIS: Trabeculectomy (TRAB) surgery reduces the intraocular pressure (IOP) more than the XEN45 implant over 3 years. There is no difference in the number of antiglaucoma medications between the 2 procedures. The decision to perform either TRAB or XEN45 implantation must be evaluated on a case-by-case basis, taking into account the high rate of needling of the XEN45. PURPOSE: The aim of this study was to compare the differences between the efficacy and safety of the XEN45 implant and TRAB, either alone or in combination with phacoemulsification (PHACO), in patients with open angle glaucoma (OAG) at 36 months. METHODS: A retrospective, single-center and comparative study conducted on OAG patients who underwent XEN45 implantation or TRAB from 2016 to 2018. Patients were divided into 4 groups: group 1 (XEN45 alone), group 2 (XEN45+PHACO), group 3 (TRAB alone), and group 4 (TRAB+PHACO). For statistical purposes, groups 1 and 2 were combined (XEN45 implant), whereas groups 3 and 4 were also combined (TRAB surgery). IOP, number of glaucoma medications, and adverse events were evaluated. The main outcome measure was the reduction in IOP at 36 months postoperatively. RESULTS: One hundred thirty-four patients (134 eyes; 63 XEN45 and 71 TRAB) were included. The mean (95% confidence interval) IOP reduction at the end of the study follow-up was -6.3 (-11.0 to -1.6 mm Hg, P =0.025, XEN45 alone), -8.9 (-11.0 to -6.8 mm Hg, P <0.001, TRAB alone), -2.5 (-4.5 to -0.4 mm Hg, P =0.019, XEN45+PHACO), and -5.6 (-7.7 to -3.4 mm Hg, P <0.001, TRAB±PHACO). The proportion of patients achieving an IOP≥6 and ≤16 mm Hg without treatment at the end of the 36-month follow-up were 50.8% (32/63) in the XEN45 implant and 49.3% (35/71) in the TRAB surgery group, P =0.863. The mean number of glaucoma medications was significantly reduced in all the study groups. The needling rate was 19% in XEN45 versus 5.6% in the TRAB group ( P =0.030), and 2.81% and 36.6% of eyes in the TRAB group presented anterior chamber flattening and hyphema, respectively. CONCLUSIONS: TRAB surgery lowered IOP significantly more than XEN45 implant with or without phacoemulsification over 3 years and had a significantly lower need for additional needling surgery. Both procedures reduced glaucoma medications to a similar rate. These findings are relevant to the informed consent process and patient decisions for one procedure over the other.

Corneal Endothelial Dysfunction as a Manifestation of Digoxin Toxicity.

PURPOSE: The purpose of this study was to report a case of corneal endothelial dysfunction and subsequent corneal edema in a patient with digoxin toxicity. METHOD: This was a case report. RESULTS: A 77-year-old woman diagnosed with open-angle glaucoma and treated with a topical prostaglandin analog for 5 years developed blurred vision and photopsia in both eyes. Systemic medications included digoxin, furosemide, apixaban, amlodipine, enalapril, and simvastatin. Ocular examination revealed folds in Descemet membrane and corneal stromal edema in both eyes, with normal fundoscopy. Ancillary tests revealed elevated serum digoxin levels. No intervention other than discontinuation of digoxin was initiated. The corneal edema improved after that and resolved in the next 2 weeks. CONCLUSIONS: We encountered 1 case of corneal edema secondary to corneal endothelial dysfunction in a patient with digoxin toxicity. Special care should be taken to elicit a complete history because ocular signs can be manifestations of systemic alterations with vital importance for patients.

XEN implant device versus trabeculectomy, either alone or in combination with phacoemulsification, in open-angle glaucoma patients.

PURPOSE: To compare the efficacy and safety of the XEN45 implant with that of trabeculectomy (TRAB), either alone or in combination with phacoemulsification (PHACO), in patients with open-angle glaucoma (OAG). METHODS: Retrospective, single-center and comparative study conducted on OAG patients. Patients were divided into four groups: group 1 (XEN alone); group 2 (XEN+PHACO); group 3 (TRAB alone); group 4 (TRAB+PHACO). For statistical purposes, groups 1 and 2 were combined (XEN implant), while groups 3 and 4 were also combined (TRAB surgery). The main outcome measure was intraocular pressure (IOP). RESULTS: Ninety-one patients (121 eyes; 65 XEN and 56 TRAB) were included. IOP reduction was - 6.7 (- 10.4 to - 3.0) mmHg, p = 0.0013; - 3.5 (- 5.0 to - 2.0) mmHg, p < 0.0001; - 8.1 (- 10.4 to - 5.9) mmHg, p < 0.0001l; and - 7.3 (- 9.3 to - 5.3) mmHg, p < 0.0001 in the XEN alone, XEN+PHACO, TRAB alone, and TRAB+PHACO, respectively. At month 12, an IOP ≥ 6 and ≤ 16 mm without treatment was achieved by 44 (67.7%) and 43 (76.8%), p = 0.2687 in the XEN implant and the TRAB surgery groups, respectively. The mean number of antiglaucoma medications was significantly reduced in all the study groups (p < 0.0001 each). Needling occurred in 20.0% (13/65) of eyes in the XEN implant group, while hyphema occurred in 30.4% (17/56) of eyes in the TRAB group. CONCLUSIONS: XEN implant, either alone or in combination with phacoemulsification, significantly reduces both IOP and the number of antiglaucoma medications to a similar rate than trabeculectomy, but with a better safety profile.