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Prcis: The PAUL Glaucoma Implant is an effective intraocular pressure (IOP)-lowering device with an acceptable safety profile. Its design as a nonvalved device with a small tube diameter using a vicryl ligation suture around the tube that is posteriorly reabsorbed instead of an ab luminal stent makes it an option in cases selected for glaucoma drainage device implantation., Purpose: The aim was to determine the 1-year efficacy and safety of PAUL Glaucoma Implant using a uniform, standardized surgical procedure., Materials and Methods: Retrospective, cohort study. Patient charts were screened between December 2018 and January 2020, with inclusion requiring a minimum follow-up of 12 months. Primary outcome was IOP-lowering at 12 months, with surgical success defined as ≤18 mm Hg and at least 30% reduction and higher than 5 mm Hg. Absolute success was achieved if no IOP-lowering medication was needed and qualified success if otherwise. Safety outcomes were also analyzed. A standardized protocol was followed in all cases, which included mitomycin C application and 1 vicryl ligation of the tube., Results: A total of 24 eyes from 21 patients fulfilled inclusion criteria. Median patient age at time of surgery was 42 years (range: 1 to 76 y). IOP decreased from 31.4 (10.0) mm Hg in preoperative period to 12.5 (4.3) mm Hg in the last follow-up (P<0.001). Qualified success criteria were fulfilled by 75% of cases, while absolute success was 33%. The mean number of IOP-lowering drugs used before surgery was 3.0 and 0.9 at the 12-month visit (P<0.001). No postoperative hypotony requiring intervention was recorded., Conclusions: PAUL Glaucoma Implant appears to be a safe and effective glaucoma drainage implant for the treatment of moderate and advanced glaucoma., Competing Interests: Disclosure: The authors declare no conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: To analyse the long-term efficacy and safety of bleb needling in glaucoma patients previously submitted to XEN implantation., Methods: Retrospective, observational study. Charts from patients who underwent XEN gel implant surgery between October 2015 and December 2017 were reviewed. Needling protocol involves use of Mitomycin C 0.2 mg/mL in an operating room. Primary outcome was defined as intraocular pressure (IOP) lowering efficacy at 12 months post-operative. Complete success was defined as a decrease in IOP > 20% and overall value <18 mmHg. Secondary outcomes included safety parameters (both intra and post-operative). Exploratory analysis of predictive factors for success were performed. Statistical analysis was performed using SPSS version 24., Results: About 94 charts were reviewed, with 18 patients (19%) having undergone needle revision. This salvage procedure was performed after 3.3 ± 3.4 months, achieving a mean IOP reduction of 8.3 ± 8.4 mmHg at 12 months after the procedure (pre-needling: 24.0 ± 5.2 mmHg vs 12th month: 13.5 ± 5.9 mmHg, p  < 0.0001). Accordingly, success was achieved in 72% (complete success in 61% of cases). Among predictive factors, there was a higher tendency for success in patients on two types of medications or fewer pre-operatively, cases of standalone XEN surgery and patients with a higher IOP difference pre-needling - day 1. No vision-threatening complications were recorded., Conclusion: XEN salvage procedure with mitomycin C is a valid option in early bleb failure. This single intervention had a long-lasting effect on bleb survival, with almost two-thirds achieving long term significant drop-free IOP reduction.

Purpose: The Baerveldt-XEN technique is intended to reduce the risk of early hypotony after Baerveldt implant, while keeping a good long-term intra-ocular pressure (IOP) control. The aim of this study is to discuss the surgical success rate of the Baerveldt-XEN and compare it with the commercially available flow-restrictor device (Ahmed glaucoma valve - AGV)., Methods: Single-centre, cohort study. Consecutive glaucoma patients with uncontrolled IOP > 21 mmHg on maximum tolerated medical therapy, and who had an aqueous shunt as the planned surgical procedure. Patients underwent implantation of Baerveldt-XEN. An age-, gender- and glaucoma aetiology-matched database of AGV patients was used for comparison. Complete surgical success was defined as a final IOP between 6 and 21 mmHg, and 20% reduction from baseline with no need for IOP-lowering medication. Qualified success was the same criteria but resorting to medications., Results: Twenty-four eyes from 24 subjects with glaucoma were included in this study, 12 patients underwent Baerveldt-XEN implantation and 12 AGV. Twelve months after the Baerveldt-XEN implant, the IOP reduced from 33 ± 9 mmHg to 14 ± 3 mmHg (p < 0.001). The qualified and complete success rate was 50% and 25%, respectively. With the AGV, the IOP reduced from 29 ± 7 mmHg to 16 ± 7 mmHg (p = 0.001). The matched AGV group compared to the Baerveldt-XEN, presented a higher complete success rate (58.3%) and a qualified success rate of 33.3% (p = 0.72). No sight-threatening complications were recorded in both groups., Conclusions: The Baerveldt-XEN disclosed a low complete success rate at 1 year of follow-up, although with no major safety concerns. While studies with a longer follow-up are needed to demonstrate the potential advantages and disadvantages of the Baerveldt-XEN, this technique may be less likely to achieve drop-free efficacy when compared to other flow-restrictor strategies., (© 2020 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

PRéCIS:: Angle location of the XEN implant both in isolated and in combined procedures did not appear to influence long-term outcomes. However, more posterior stent placements seem to be associated with increased early postoperative complications., Purpose: The purpose of this study was to assess success and safety outcomes of different levels of insertion of the XEN45 gel stent in the angle in standalone and combined procedures., Methods: This was a cross-sectional study of patients in whom XEN had been implanted without intraoperative gonioscopy. Automated gonioscopy was used for postoperative analysis of the XEN location, classified as anterior or posterior relative to the scleral spur. Absolute success was defined as ≥20% intraocular pressure decrease from baseline and ranging from 6 to 21 mm Hg without medication and qualified success if medicated. The need for additional drainage surgery was considered failure, but needling was allowed. Clinical data were retrieved from patient files., Results: Gonioscopy-assisted XEN location was performed on 42 eyes of 33 patients (14 isolated and 28 combined procedures) on average 18±9 months after surgery. Absolute (32% vs. 35%; P>0.99) and qualified (44% vs. 65%; P=0.22) success was similar in both anterior and posterior placements, respectively. Kaplan-Meier survival analysis yielded similar median survival times for both groups. The distribution of XEN insertion level in the angle was similar in standalone and combined procedures (P=0.75). Although overall safety outcome measures did not differ significantly, the proportion of intraoperative and early postoperative complications was higher in posterior XEN placements (P=0.03)., Conclusions: Different locations of XEN45 did not seem to significantly impact late success and safety outcomes, although stents inserted more posteriorly may be associated with a higher rate of early complications. Combined implantation of XEN with phacoemulsification does not seem to influence stent location in the iridocorneal angle in a setting without intraoperative gonioscopy.