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.

XEN Gel Stent Versus Nonpenetrating Deep Sclerectomy in Ocular Hypertension and Open Angle Glaucoma Patients.

PRCIS: XEN gel stent and nonpenetrating deep sclerectomy, both either alone or in combination with cataract surgery, significantly lowered the intraocular pressure (IOP) and reduced the number of antiglaucoma medications in patients with open angle glaucoma, with no significant differences between them. PURPOSE: To compare the surgical outcomes of XEN45 implant and nonpenetrating deep sclerectomy (NPDS), either alone or in combination with cataract surgery, in patients with ocular hypertension and open angle glaucoma (OAG). A retrospective and single-center cohort study was conducted on consecutive patients who underwent a XEN45 implant or an NPDS, either alone or in combination with phacoemulsification. The primary endpoint was the mean change in IOP from the baseline to the last follow-up visit. One hundred twenty-eight eyes, 65 (50.8%) eyes in the NPDS group and 63 (49.2%) eyes in the XEN group, were included in the study. The mean preoperative IOP was significantly lowered from 17.6±5.3 mm Hg and 17.8±6.2 mm Hg to 12.6±2.6 mm Hg and 13.8±2.8 mm Hg at month 12 in the XEN and NPDS groups, respectively; P <0.0001 each. At month 12, 70 (54.7%) eyes were classified as a success, with no significant differences between XEN (57.1%; 36/63 eyes) and NPDS (52.3%; 34/65 eyes) (mean difference: 4.8%; 95% CI: -30.5% to 20.8%; P =0.7115). The number of ocular hypotensive medications was significantly reduced in the XEN (from 2.1±0.7-0.2±0.5, P <0.0001) and in the NPDS (from 2.0±0.8 to 0.3±0.6, P <0.0001) groups, with no significant differences between them ( P =0.2629). The incidence of postoperative adverse events in the overall study population was 12.5%, with no significant differences between groups ( P =0.1275). Seven (11.1%) eyes underwent needling (XEN group) and 10 (15.4%) goniopuncture (NPDS group); P =0.4753. CONCLUSIONS: XEN45 implant and the NPDS, either alone or in combination with cataract surgery, significantly lowered IOP and reduced the number of ocular hypotensive medications in ocular hypertension and patients with open angle glaucoma.

Impact of Primary Needling on the XEN Implant Clinical Outcomes: A Real-Life Retrospective Study.

Purpose: To assess the effectiveness and safety of primary-needling in eyes who underwent a XEN45 implant. Methods: Retrospective and single center study. Consecutive patients with early-to-moderate open-angle glaucoma (OAG) or ocular hypertension, who underwent XEN45 surgery, either alone or combined with phacoemulsification, and had at least a valid 12-month post-operative visit, were included in the study. Primary needling was performed by using a 30-gauge needle without viscoelastic. Subjects were divided in two groups: Eyes who underwent XEN+primary-needling (needling) and those who underwent XEN without primary-needling (no-needling). The primary end-point was the mean change in IOP from baseline to the last follow-up visit. Results: Sixty-three eyes, 19 (30.2%) in the needling group and 44 (69.8%) in the no-needling one, were included in the study. There were not significant differences in mean IOP lowering between needling and no-needling groups at month-12 (mean difference -2.5±5.3 mm Hg, p=0.0926). No significant differences in mean reduction of ocular-hypotensive medications were observed between needling and no-needling groups, p=0.8690. At month-12, 50 (80.6%) had blebs considered as functioning, with no difference between groups, p = 0.5631. At month-12, 59 (93.7%) eyes were classified as success, with no significant differences between needling (17/19) and no-needling (42/44) groups, p=0.3754. Secondary needling was performed in 8 (12.7%) eyes, without differences between groups (p=0.6333). Conclusion: Primary needling, at the time of surgery, was a safe procedure in OAG patients who underwent a XEN implant, although it was not associated with a lower postoperative IOP or less ocular hypotensive medications.

Does mitomycin-C concentration have any influence on XEN45 gel stent outcomes in a real-world setting?

BACKGROUND: To compare the effectiveness and safety of XEN45 implanted with mitomycin-C (MMC) 0.01% versus (vs) XEN45 implanted with MMC 0.02%. METHODS: Retrospective and single-center study conducted on consecutive patients with open-angle glaucoma or ocular hypertension who underwent XEN45-implant, either alone or in combination with cataract surgery. The primary end-point was the mean change in intraocular pressure (IOP) from baseline to the last follow-up visit. RESULTS: Fifty-five patients (63 eyes) were included. Thirty-seven (58.7%) eyes underwent surgery with MMC 0.01% and 26 (41.3%) ones with MMC 0.02%. In the overall study sample, the mean (standard error) IOP was significantly lowered from 17.6 (0.7) mm Hg at baseline to 12.6 (0.3) mm Hg at month 12. The IOP was significantly lowered from 17.3 (15.4 to 19.2) mm Hg and 17.9 (16.1 to 17.8) mm Hg at baseline to 12.3 (11.3 to 13.3) mm Hg and 13.1 (12.3 to 13.9) mm Hg at month 12 in the MMC 0.01% and MMC 0.02% groups, respectively; p < 0.0001 each. The mean number of ocular-hypotensive medications significantly decreased from 2.1 (1.9 to 2.3) at baseline to 0.2 (0.04 to 0.3) at month 12, p < 0.0001, with no significant differences between MMC 0.01% and MMC 0.02% groups, p = 0.5181. At month 12, 50 (80.6%) eyes had functioning blebs. Regarding safety, 18 (28.6%) eyes have experience adverse events. CONCLUSION: XEN45, either alone or in combination with cataract surgery, showed a good effectiveness and safety profile. MMC dose had no influence on the IOP lowering, which may support the use of the lowest dose.

Management of the leakage of aqueous humour caused by the wound in a cataract surgery post-operative period with Nd:YAG laser.

PURPOSE: To describe a new technique for sealing aqueous leakage after cataract surgery using Nd:YAG laser. INTRODUCTION: The leakage of aqueous humour through the corneal incisions after a surgical procedure still is one of the main complications in the cataract surgery post-operative period. Its cause depends on multiple factors, among which we find the structure of the incision. Several methods to treat its ending have been proposed over the years, and there is not a definitive and standardised method. Although most of the times they are mild and self-limited, in the cases in which the aqueous humour leakage is more profuse, a treatment is needed to avoid the risk of other complications, mainly contaminations that cause infections. METHODS: The technique consists of generating intrastromal microbubbles with the Nd:YAG laser to increase the pressure against the tunnel, achieving its sealing. It is applied on the corneal stroma, next to the incision plane. Power is set between 1.5 and 2.0 mJ (millijoules), with offset set to 0, and normally between four and six single shots would be sufficient. RESULTS: We have achieved the closure in all the patients that we performed this procedure so far. CONCLUSIONS: We describe an easy and very effective technique for the sealing of the incision with an aqueous humour leakage in the immediate post-operative period of the cataract surgery by using the YAG:Nd laser, allowing a prompt and accessible treatment with a good safety profile, and reducing the need for new procedures and additional check-ups.

High interpretable machine learning classifier for early glaucoma diagnosis.

AIM: To develop a classifier for differentiating between healthy and early stage glaucoma eyes based on peripapillary retinal nerve fiber layer (RNFL) thicknesses measured with optical coherence tomography (OCT), using machine learning algorithms with a high interpretability. METHODS: Ninety patients with early glaucoma and 85 healthy eyes were included. Early glaucoma eyes showed a visual field (VF) defect with mean deviation >-6.00 dB and characteristic glaucomatous morphology. RNFL thickness in every quadrant, clock-hour and average thickness were used to feed machine learning algorithms. Cluster analysis was conducted to detect and exclude outliers. Tree gradient boosting algorithms were used to calculate the importance of parameters on the classifier and to check the relation between their values and its impact on the classifier. Parameters with the lowest importance were excluded and a weighted decision tree analysis was applied to obtain an interpretable classifier. Area under the ROC curve (AUC), accuracy and generalization ability of the model were estimated using cross validation techniques. RESULTS: Average and 7 clock-hour RNFL thicknesses were the parameters with the highest importance. Correlation between parameter values and impact on classification displayed a stepped pattern for average thickness. Decision tree model revealed that average thickness lower than 82 µm was a high predictor for early glaucoma. Model scores had AUC of 0.953 (95%CI: 0.903-0998), with an accuracy of 89%. CONCLUSION: Gradient boosting methods provide accurate and highly interpretable classifiers to discriminate between early glaucoma and healthy eyes. Average and 7-hour RNFL thicknesses have the best discriminant power.