One-Year Efficacy and Safety of the PAUL Glaucoma Implant Using a Standardized Surgical Protocol.

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.

Automated Gonioscopy Assessment of XEN45 Gel Stent Angle Location After Isolated XEN or Combined Phaco-XEN Procedures: Clinical Implications.

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.