Needling after XEN gel implant: What's the efficacy? A 1-year analysis.

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.

High intensity focused ultrasound for glaucoma: 1-year results from a prospective pragmatic study.

BACKGROUND: Ciclo plasty using high-intensity focused ultrasound (HIFU) technology acts through the selective coagulation of the ciliary body. Our aim was to evaluate the safety and efficacy profiles of 8-s probe HIFU cyclocoagulation using the EyeOP1 device. METHODS: Prospective pragmatic trial. INCLUSION CRITERIA: adult glaucoma patients with uncontrolled IOP despite optimised medical therapy, and/or intolerant to medical therapy required to achieve target IOP. PRIMARY OUTCOME: surgical success defined as IOP reduction from baseline >20% with final IOP ≤21 mmHg, without adding any IOP-lowering drugs, and without loss of light perception; or decreased use of IOP-lowering drugs with stable/decreased IOP, without loss of light perception. SECONDARY OUTCOMES: mean IOP, intra and postoperative complications, best-corrected visual acuity (BCVA) and number of IOP-lowering drugs at each visit. Outcome data were collected preoperatively and at postoperative day 1, and months 1, 3, 6 and 12. RESULTS: Forty-nine eyes of forty-nine patients (28 male) with a mean age of 70 ± 14 years were enroled. Pre-operative IOP was 26.9 ± 7.4 mmHg under 2.8 ± 0.9 topical medications, decreasing to 17.8 ± 6.4 mmHg under 2.3 ± 1 drugs at 12 months (p < 0.01). One-year surgical success was achieved in 71.4% of patients (IOP-reduction criteria: 59.2%; decreased use of IOP-lowering drugs: 38.8%). Eight patients were ultimately submitted to other glaucoma surgical interventions. Five patients experienced serious adverse events (loss of light perception n = 5; hypotony n = 1). CONCLUSIONS: This innovative non-invasive technology seems to be effective in decreasing IOP and/or the number of administered drops in patients with refractory glaucoma. It seems a valuable tool to delay or preclude the need for filtering procedures in the majority of the patients.

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.

XEN-augmented Baerveldt surgical success rate and comparison with the Ahmed Valve.

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.

Glaucoma Gel Implant Learning Curve in a Teaching Tertiary Hospital.

PURPOSE: The XEN gel stent is a minimally invasive surgical device aimed at creating a subconjunctival drainage of aqueous humor, thereby reducing intraocular pressure (IOP). Being a novel device, doubts remain with regard to the efficacy and safety of its implantation in the early stage of new users. This paper illustrates the XEN implantation learning curve, assessed through several surgeons of different expertise. METHODS: This was a retrospective study on the first 6 XEN implants performed by each of the 10 certified ophthalmic surgeons. Simultaneous cataract surgery was allowed (phaco-XEN). Primary outcomes were as follows: surgical time; intraoperative and postoperative surgical complications. Secondary outcomes were as follows: IOP; the number of topical drugs in use; the need for needling procedures. Outcome data were collected preoperatively and at postoperative days 1, 7, 15, 30, 60, and 90. Statistical analysis was performed with STATA 14.1 and SPSS. RESULTS: Sixty patients were included (56.7% female patients). Mean age was 73 years (45 to 89). Mean preoperative IOP was 23.8±8.95 mm Hg. From the included patients, 29 (48.3%) were submitted to simple XEN implant and 31 (51.7%) to phaco-XEN. In both groups, mean surgical time decreased by 9 minutes throughout the 6-implant learning curve. Final IOP was 15±7.27 mm Hg in the stent group (-43% than baseline), and 14.92±3.32 mm Hg in the phaco-XEN group (-16% than baseline). On average, patients decreased 2 topical IOP-lowering drugs. Needling procedures were performed in 17 patients (28.3%). CONCLUSIONS: XEN gel stent was associated with a fast learning curve, by both experienced surgeons and novice residents. By the sixth implant, both groups had considerably decreased mean surgical time and complication rates.

Baerveldt-XEN persistent proximal occlusion: solving new problems with old answers.

A 51-year-old woman was referred with uncontrolled intraocular pressure (IOP) despite maximal medical IOP-lowering therapy. Her background included several failed glaucoma filtering surgeries, including aqueous drainage devices. Considering the need to perform surgery in a patient with both scarred conjunctiva and corneal endothelial deficiency, a surgical technique combining cornea-friendly XEN stent connected to a large-plate Baerveldt glaucoma implant was undertaken. Unfortunately, XEN implants obstructed twice during the early postoperative period. As further XEN replacements were unfeasible, there was the need to bridge the gap between the Baerveldt tube and the anterior chamber. An easy accessible, cheap 22G angiocatheter segment was used for this purpose. With a follow-up of 6 months, there were no postoperative complications nor loss of efficiency, with IOP of 7 mmHg. Tube extension using angiocatheter is a viable, cost-effective option in these difficult cases, saving the surgeon from having to explant and replace the entire implant.