Midterm Survival Results of Preserflo® in a Real-world Setting: A Retrospective 2-year Analysis.

PRCIS: Preserflo® surgery is a safe procedure, effective in reducing intraocular pressure into the "low teens", surgical survival is greatest in cases of high baseline intraocular pressure (above 21 mmHg) and when performed as a standalone procedure. PURPOSE: To evaluate midterm surgical survival and safety profile of Preserflo® filtering surgery. METHODS: Retrospective, cohort study. Consecutive patients who underwent standardized Preserflo® implantation with mitomycin C from December 2019 to April 2021 were included. Clinical data was retrieved from patient charts. Primary outcome was surgical survival at twenty-four months in accordance with World Glaucoma Association guidelines. Survival was evaluated using Kaplan-Meier statistics. Analysis was performed at eye-level and as intention-to-treat. RESULTS: Ninety-five eyes were included in this study (18 cases combined with cataract surgery). Over half of cases (n=51) were primary open angle glaucoma, with over a fifth having a prior filtering glaucoma procedure. Intraocular pressure at twenty-four months was significantly decreased from baseline (22.4±6.28 mmHg vs 12.0±3.43 mmHg), as well as the need for IOP-lowering medication (2.88 (±0.92) vs 0.79 (±1.3), P<0.001 all comparisons. Standalone Preserflo® achieved a qualified survival (irrespective of medication) of 71% (CI 95% 62%-83%) and 44% (CI 95% 27%-75%) in the combined procedure subgroup (P<0.05 when considering absolute survival). Eyes with baseline intraocular pressure ≥21 mmHg showed a greater qualified survival when compared to eyes with baseline ≤18 mmHg (80% (CI 95% 65%-100%) vs (50% (CI 95% 32%-76%; P<0.05). Intra and early operative complications were few, self-limited, and did not require surgical management. The reoperation rate was low (18%). CONCLUSION: Preserflo ® filtering surgery is effective in reducing intraocular pressure into the "low teens" and presents an adequate surgical survival and safety profile. Surgical survival appears greatest when performed as standalone and when pre-operative intraocular pressure is high (≥21 mmHg).

Treatment Outcomes Comparing the Paul and Baerveldt Glaucoma Implants After One Year of Follow-Up.

PRCIS: In reducing intraocular pressure (IOP), Paul (PGI) and Baerveldt (BGI) glaucoma implants are safe and effective in patients with glaucoma. OBJECTIVE: To compare efficacy and safety profiles of the PGI and BGI in the treatment of medically uncontrolled glaucoma at 1 year of follow-up. METHODS: Retrospective analysis of patients implanted with a PGI or BGI with a minimum of 12 months follow-up. The primary outcome was surgical success defined as IOP ≥6 and ≤18 mm Hg and at least 20% IOP reduction from baseline. Secondary outcomes included IOP measurements, number of medications, and complications. RESULTS: Twenty-three patients implanted with PGI and 27 with BGI were included. At last visit (12 mo), mean IOP had decreased from 23.7 ± 6.9 to 0.1 ± 2.9 mm Hg in the PGI group versus 26 ± 7.3 to 10.4 ± 4.9 mm Hg with the BGI ( P < 0.001 for both comparisons). Overall qualified success rates were similar between groups (PGI 91% vs BGI 89%, P = 0.784). IOP was significantly lower in the PGI at week 1 and month 1 of follow-up versus the BGI (13.6 ± 6.1 vs 20.1 ± 7.4; 14.6±3.8 vs 21.2 ± 5.8 mm Hg; P < 0.002 for both) with a lower number of medications (1.57 ± 1.47 vs 2.52 ± 1.16 at mo 1, P = 0.015). Most complications were minor and similar in both groups. CONCLUSION: Both PGI and BGI are safe and effective in reducing IOP in patients with glaucoma, with similar success rates.

Design and Development of a Web-Based Prospective Nationwide Registry for Ocular Inflammatory Diseases: UVEITE.PT - The Portuguese Ocular Inflammation Registry.

Uveitis is a heterogeneous collection of infrequent diseases, which poses significant challenges to cost-effective research in the field. Medical registries are being increasingly recognized as crucial tools to provide high-quality data, thus enabling prospective clinical research. This paper describes the design and technical structure development of an innovative countrywide electronic medical record for uveitis, Uveite.pt, and gives an overview of the cohort registered since its foundation, March 2020.Uveite.pt is an electronic medical record platform developed by the Portuguese Ocular Inflammation Group (POIG), a scientific committee of the Portuguese Ophthalmology Society. This is a nationwide customized web-based platform for uveitis patients useful for both clinical practice and real-world-based research, working as a central repository and reporting tool for uveitis. This paper describes the technical principles, the design and the development of a web-based interoperable registry for uveitis in Portugal and provides an overview of more than 400 patients registered in the first 18 months since inception.In infrequent diseases, the existence of registries enables to gather evidence and increase research possibilities to clinicians. The adoption of this platform enables standardization and improvement of clinical practice in uveitis. It is useful to apprehend the repercussion of medical and surgical treatments in uveitis and scleritis, supporting clinicians in the strict monitoring of drug adverse reactions and surgical outcomes.

Artificial intelligence for glaucoma: state of the art and future perspectives.

PURPOSE OF REVIEW: To address the current role of artificial intelligence (AI) in the field of glaucoma. RECENT FINDINGS: Current deep learning (DL) models concerning glaucoma diagnosis have shown consistently improving diagnostic capabilities, primarily based on color fundus photography and optical coherence tomography, but also with multimodal strategies. Recent models have also suggested that AI may be helpful in detecting and estimating visual field progression from different input data. Moreover, with the emergence of newer DL architectures and synthetic data, challenges such as model generalizability and explainability have begun to be tackled. SUMMARY: While some challenges remain before AI is routinely employed in clinical practice, new research has expanded the range in which it can be used in the context of glaucoma management and underlined the relevance of this research avenue.

Bleb morphology of glaucoma drainage devices on magnetic resonance imaging.

PURPOSE: To evaluate bleb morphology features of different glaucoma drainage devices (GDD) using magnetic resonance imaging (MRI). MATERIALS AND METHODS: Prospective cohort study of GDD and bleb morphology in consecutive glaucoma patients implanted with Ahmed Glaucoma Valve (AGV), Paul Glaucoma Implant (PGI), Baerveldt Glaucoma Implant (BGI) and Ahmed ClearPath (ACP) devices. Thirty-six eyes from 30 consecutive patients underwent standardized GDD implantation followed by MRI at least 1 month after surgery. Main outcomes included bleb volume and endplate position relative to the optic nerve. Secondary outcomes included intraocular pressure (IOP), medication and surgical complications during a 12-month follow-up. RESULTS: Seven eyes were implanted with the AGV (19%), 5 with BGI (14%), 16 with PGI (44%) and 8 with ACP (22%). MRI scans were obtained 85 ± 66 days after surgery. Mean total bleb volume was 563 ± 390 mm3 . This bleb volume was inversely correlated with early post-operative IOP (day 7; rs = -0.3326, p = 0.0475) but positively correlated with IOP at 12 months (rs = 0.3592, p = 0.0341). No significant difference in total bleb volume was found between GDD types (p = 0.1223). A double-layered bleb was observed in 34 eyes (94%). The inferior bleb volume was significantly larger in PGI devices versus other GDD types (380 ± 205 vs. 193 ± 161 mm3 ; p = 0.0043). Distance from the endplate to the optic nerve was 9.5 ± 4.0 mm, similar across GDDs (p = 0.2519). CONCLUSIONS: Double-layered blebs are a common finding with GDDs. Bleb volume showed different correlations with IOP at distinct timepoints and the PGI device formed larger blebs. A standardized GDD implantation technique ensures a safe distance from the GDD endplate to the optic nerve.

Keratoconus tomographic indices in osteogenesis imperfecta.

PURPOSE: Osteogenesis imperfecta (OI) is a rare inherited disease affecting collagen-rich tissues. Ocular complications have been reported such as thin corneas, low ocular rigidity, keratoconus, among others. The purpose of this study is to characterize corneal tomographic features in OI patients compared to unaffected patients, with particular focus on commonly studied keratoconus indices. METHODS: Cross-sectional case-control study including 37 OI patients and 37 age-matched controls. Patients and controls underwent comprehensive ophthalmological examination including corneal Scheimpflug tomography with a Pentacam HR device (Oculus Optikgeräte GmbH, Wetzlar, Germany) to analyse and compare topometric, tomographic, pachymetric and Belin-Ambrósio Enhanced Ectasia Display III (BAD-D) data of both eyes of each patient. RESULTS: Most OI patients had type I disease (n = 24; 65%) but type III-VII patients were also included. Two patients had clinically overt bilateral keratoconus. OI patients had significantly higher maximum keratometry (45.2 ± 2.1 vs. 43.7 ± 1.2; p = 0.0416), front and back elevation (3.0 ± 3.3 vs. 2.1 ± 1.3, p = 0.0201; 11.1 ± 8.2 vs. 5.0 ± 3.7, p < 0.0001), index of surface variance (25.5 ± 13 vs. 17.4 ± 8.3; p = 0.0016), index of vertical asymmetry (0.21 ± 0.14 vs. 0.15 ± 0.06; p = 0.0215), index of height asymmetry (9.2 ± 14 vs. 6.0 ± 4.5; p = 0.0421), index of height decentration (0.02 ± 0.01 vs. 0.01 ± 0.01; p < 0.0001) and average pachymetric progression (1.01 ± 0.19 vs. 0.88 ± 0.14; p < 0.0001) readings. Thinnest corneal thickness and maximum Ambrósio relational thickness were significantly lower (477 ± 52 vs. 543 ± 26; 387 ± 95 vs. 509 ± 49; p < 0.0001). Two-thirds of OI patients had corneas with a minimum thickness < 500 µm. BAD-D value was significantly higher in OI patients (2.1 ± 1.4 vs. 0.9 ± 0.2; p < 0.0001). CONCLUSION: OI patients showed significant changes in corneal profiles compared with healthy subjects. A high proportion of patients had tomographically suspect corneas when using keratoconus diagnostic indices. Further studies are warranted to assess the true risk of corneal ectasia in OI patients.

Glaucoma triage system: results of implementing a virtual clinic.

PURPOSE: This study describes the virtual clinic triage system implementation process at Hospital Santa Maria-Centro Hospitalar Universitário Lisboa Norte (HSM-CHULN) and analyzes its results regarding healthcare outcomes for the patients and the system. METHODS: A retrospective analysis was performed, comparing two cohorts (pre-virtual cohort; virtual triage cohort). Outcomes related to waiting time, number of hospital visits, decisions at first contact, and ancillary exam-based decisions were reported. RESULTS: Two hundred and ninety-two charts were reviewed (pre-virtual cohort: 132; virtual cohort: 160). Mean waiting time between referral and the first medical contact with the glaucoma department decreased on average by 71.3 days (human contact: 286.6 days; virtual triage contact: 215.3 days). Triage system significantly decreased waiting time for glaucoma patients, with an average decrease of 326.8 days between referral and treatment decision. Triage staging allowed to label 107 (66.9; 95% confidence intervals (CI): 59.6%, 74.2%) as non-urgent; 30 (18.8%; 95% CI: 12.7%, 24.9%) as urgent, and 23 (14.3%; 95% CI: 8.9%, 19.7%) as immediate contact, with the scheduling of future appointments reflecting National Institute for Health and Care Excellence (NICE) guidelines in every patient. Moreover, the number of visits to perform the same exams and obtain the same clinical decisions was reduced by 63.6%. CONCLUSION: Our virtual screening strategy significantly decreased waiting time, number of hospital visits, and increased chances of data-assisted clinical decision. While results can be further improved, this system can add value in an overburdened healthcare system, where triage systems with remote decision-making may be valuable tools in optimizing glaucoma care, even without allocation of extra resources.

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.

Topical corticosteroids with topical cyclosporine A versus topical corticosteroids alone for immunological corneal graft rejection.

PURPOSE: To assess the efficacy and safety of supplementing topical cyclosporine A (CsA) to topical corticosteroids (CS), in the prophylaxis and treatment of corneal graft rejection following penetrating keratoplasty (PK). METHODS: Meta-analysis. Search was performed in PubMed, CENTRAL, ClinicalTrials.gov, reference lists of articles and conference proceedings. Primary outcomes: 1-year rejection-free survival rate (prophylaxis); resolution rate of rejection episodes (treatment). Secondary outcomes: 6- and 24-month rejection-free graft survival rate, number of rejection episodes during follow-up, time-to-resolution of rejection episode, 12- and 24-months graft survival rate, adverse events. Subgroup analyses were planned for high-risk grafts; primary vs. secondary prophylaxis of graft rejection episodes; and CsA concentrations of 0.05%, 1%, and 2%. RESULTS: Five studies of moderate methodological quality were included (one retrospective, four RCT), assessing 459 eyes (CS + CsA 226, CS 233). In the prophylaxis setting, supplemental CsA was associated with a higher rejection-free survival rate at 12-months (RR 1.25, 95% CI: 1.00-1.56, p = 0.05) and 24-months post-PK (RR 1.56, 95% CI: 1.15-2.11, p < 0.01), though no differences were found at the 6-months timepoint (p = 0.93). This effect was mostly verified using CsA 2% in the high-risk subset of patients. In the treatment setting, no differences were found in the resolution rate of rejection episodes (p = 0.23). No differences existed on drug-related adverse events. CONCLUSION: In the prophylaxis of rejection episodes post-PK, the combined regimen of CS + CsA was associated with a higher 1- and 2-year rejection-free graft survival rate. Subgroup analysis mostly supported the use of CsA 2% for high-risk grafts. Further studies are needed to validate these results.

Trabeculectomy with mitomycin C alone or coupled with intracamerular bevacizumab? A 2-year comparative study.

PURPOSE: To compare outcomes of primary trabeculectomy using either mitomycin C (MMC) alone versus MMC augmented with intracamerular bevacizumab in patients with open-angle glaucoma. METHODS: Retrospective, cohort, two-centre, comparative study. Patients' data were screened between October 2015 and March 2019, with inclusion requiring a minimum follow-up of 24 months. Primary outcome was intraocular pressure (IOP) lowering at 24 months, with surgical success defined with different maximum IOP targets (≤18, ≤16 and ≤14 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 a qualified success if otherwise. Safety outcomes were analysed. RESULTS: A total of 110 eyes underwent trabeculectomy with MMC, 51 of these combined with intracamerular bevacizumab. Both strategies were effective in terms of IOP lowering (baseline vs 2 years postoperatively: 24.4 (8.0) mm Hg vs 12.1 (5.3) mm Hg in the MMC group; 25.1 (8.7) vs 10.8 (3.8) mm Hg in the MMC+bevacizumab group; p<0.001 in both comparisons). The MMC+bevacizumab group had a significant difference towards higher efficacy on absolute success rates at all targets (IOP≤14 or ≤16 or ≤18 mm Hg; p=0.010, p=0.039 and p=0.007, respectively). The large majority (93%) of the MMC+bevacizumab group was drop-free at 24 months, and 41% had IOP below 10 mm Hg. Complication rates were low and similar between groups, with no systemic adverse events. CONCLUSIONS: Intracamerular bevacizumab in MMC-augmented primary trabeculectomy increases the chances of obtaining low IOP outcomes. This strategy may be useful when planning for surgeries aiming at target pressures in the low teens. TRIAL REGISTRATION NUMBER: ISRCTN93098069.

Agreement Analysis on Angle Characteristics With Automated Gonioscopy.

PRCIS: Automated gonioscopy is a recent method of recording angle pictures. Our study shows that agreement between observers is moderate in most categories used in clinical practice, underlying its clinical usefulness but also room for improvement. INTRODUCTION: Iridocorneal angle (ICA) imaging methods have been recently developed to record gonioscopic images. The purpose of this study was to perform an interrater agreement analysis of ICA photographs. METHODS: Multicentric cross-sectional observational study. Consecutive patients in 2 ophthalmology departments underwent automated gonioscopy. One picture per quadrant from each eye was selected for randomization. Pictures were graded and analyzed by 4 masked glaucoma specialists regarding angle opening, width, Shaffer and Spaeth gradings and other findings. Fleiss' κ statistics was performed to assess interrater agreement. RESULTS: A total of 50 patients were recruited, with the sample containing a variety of diagnosis including pseudoexfoliation (22%), angle-closure suspect (12%), and pigmentary glaucoma (4%). The sample included phakic (68%) and pseudophakic patients, as well as cases with gonio-implanted surgical devices (10%). There was moderate agreement on angle opening, angle width, presence of angle vessels, and peripheral anterior synechiae (κ=0.435, 0.511, 0.558, 0.488, respectively; P<0.01). Fair agreement was observed regarding Shaffer grading, site of iris root insertion, angle pigmentation features, and the presence of iris processes. Expectedly from a 2-dimensional picture, the configuration of peripheral iris was found to have a poor agreement. Subset analysis on higher quality pictures seemed to improve agreement on pigment but did not further improve on the overall good agreement on angle opening status. CONCLUSIONS: Our study shows that automated gonioscopy provides moderate agreement on most clinically relevant features. Binary characteristics such as angle opening or PAS seem to be more robust than more complex angle classification parameters.

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.

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.

Impact of laser iridotomy on headache symptoms in angle-closure subjects.

BACKGROUND: Migraine symptoms are frequently referred by glaucoma patients. Although most studies analyze headache in the acute setting of angle closure, many patients with chronic occludable angles also complain of headaches. The aim of this study was to determine the impact of laser peripheral iridotomy (LPI) on the magnitude and frequency of headache symptoms in patients with occludable angles. METHODS: Prospective cohort study. Patients with indication for prophylactic LPI due to occludable iridocorneal angle were included. Headache symptoms were assessed before and at least 4 weeks after LPI using the Headache Impact Test-6 (HIT-6) questionnaire. A HIT-6 score of ≥ 50 points was labeled as a clinically significant headache. RESULTS: Thirty-one subjects were included. Prophylactic LPI was performed in 60 eyes, as 2 patients were pseudophakic in the fellow eye. Baseline HIT-6 score was 59.9 ± 11.8, with over three quarters of these patients scoring higher than 50 points (n = 24). A statistically significant reduction in HIT-6 score was found after LPI treatment (45.4 ± 7.7, p < 0.01). Sub-analysis within the clinically symptomatic subjects disclosed a significant improvement after treatment in this group (baseline, 65.3 ± 6.2 vs post-LPI 46.2 ± 8.3, p < 0.01), with a high baseline HIT-6 score being predictive of a symptomatic improvement after LPI (χ2(8) = 15.3, p = 0.001). This is mimicked from the patient's perspective, as the two subjective questions after LPI, concerning pain intensity and frequency, report that 79.2% had a statistically significant improvement of the headaches. CONCLUSIONS: Within our sample, the majority of patients with occludable angles had clinically relevant headaches. LPI provided symptomatic relief in the majority of those patients with high HIT-6 scores. Further studies are needed to explore the relationships between headache and angle anatomy.

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.