A glaucoma micro-stent with diverging channel and stepped shaft structure based on microfluidic template processing technology.

BACKGROUND: Minimally invasive glaucoma surgery (MIGS) has experienced a surge in popularity in recent years. Glaucoma micro-stents serve as the foundation for these minimally invasive procedures. Nevertheless, the utilization of these stents still presents certain short-term and long-term complications. This study aims to elucidate the creation of a novel drainage stent implant featuring a diverging channel, produced through microfluidic template processing technology. Additionally, an analysis of the mechanical properties, biocompatibility, and feasibility of implantation is conducted. RESULTS: The stress concentration value of the proposed stent is significantly lower, approximately two to three times smaller, compared to the currently available commercial XEN gel stent. This indicates a stronger resistance to bending in theory. Theoretical calculations further reveal that the initial drainage efficiency of the gradient diverging drainage stent is approximately 5.76 times higher than that of XEN stents. Notably, in vivo experiments conducted at the third month demonstrate a favorable biocompatibility profile without any observed cytotoxicity. Additionally, the drainage stent exhibits excellent material stability in an in vitro simulation environment. CONCLUSIONS: In summary, the diverging drainage stent presents a novel approach to the cost-effective and efficient preparation process of minimally invasive glaucoma surgery (MIGS) devices, offering additional filtering treatment options for glaucoma.

Intraocular pressure spikes after gonioscopy-assisted transluminal trabeculotomy (GATT).

PURPOSE: Intraocular pressure (IOP) spikes (IOP > 30 mmHg or > 10 mmHg above baseline IOP) are a common and worrisome complication of gonioscopy-assisted transluminal trabeculotomy (GATT). The purpose of this study is to identify risk factors for IOP spikes and to describe their characteristics, management, and clinical course in a large cohort of patients. METHODS: A retrospective, single-center study which included 217 consecutive eyes of patients that underwent GATT between December 2019 and April 2022 with follow-up of at least 90 days. RESULTS: IOP spikes occurred in 52 of 217 (24%) eyes. Spikes occurred in 15.5% of patients in whom pre-operative IOP-lowering medications were continued after surgery (90 eyes), and in 29.9% in whom IOP-lowering medications were stopped after surgery (127 eyes). Spikes were diagnosed at a mean of 7.7 ± 6.5 days after surgery. All IOP spikes occurred within the first month of surgery. The mean duration of a spike was 4.9 ± 5.4 days. Management of IOP spikes included adding a mean of 3.13 ± 1.7 groups of glaucoma medications. Thirty-seven (72.5%) eyes were treated with oral carbonic anhydrase inhibitor, 11 (21.6%) were treated with IV mannitol, and anterior chamber paracentesis was performed in 16 (31.4%). Six (11.8%) eyes underwent additional glaucoma surgery to control IOP. Patients that continued their pre-operative IOP-lowering medications after surgery were 2.3 times less likely to develop a spike as compared to patients who discontinued their medications (P = 0.016). Spikes were found to be a risk factor for failure of GATT. CONCLUSIONS: IOP spikes are a common occurrence after GATT. They most commonly appear during the first two post-operative weeks and usually resolve with topical and systemic IOP-lowering treatment. The continuation of IOP-lowering medications after GATT is recommended to lower the risk of IOP spikes.

Combined versus standalone XEN45 Gel Stent implantation in either phakic or pseudophakic patients: a case-matched study.

PURPOSE: To determine differing outcomes among either phakic or pseudophakic patients who received standalone XEN45 Gel Stent (Allergan, an AbbVie Company, CA, USA) implantation and patients who underwent combined surgery with phacoemulsification. METHODS: This retrospective single-center study involved 180 eyes of 180 participants who underwent XEN45 Gel Stent implantation, of which 60 eyes received combined surgery with phacoemulsification (combined group). Standalone stent implantation was performed on 60 phakic (phakic group) and on 60 pseudophakic eyes (pseudophakic group). The groups were matched in a ratio of 1:1:1 based on multiple criteria. Successful surgery was defined by three scores: IOP at the longest follow-up of < 21 mmHg (Score A) or < 18 mmHg (Score B) and an IOP reduction > 20% or IOP ≤ 15 mmHg and an IOP reduction ≥ 40% (Score C). In all scores, one open conjunctival revision was allowed, and additional repeat surgery was considered a failure. RESULTS: After an average follow-up time interval of 20.6 ± 12.6 months, there was a mean IOP-reduction by 37% among the entire cohort. Comparative analysis between the three groups did not show significant differences regarding postoperative IOP, postoperative medication score, side effects, revision rate, repeat surgery rate or success rate. A dysfunctional stent was detected in eight eyes (4%) during open conjunctival revision in 76 eyes. CONCLUSION: The clinical endpoints investigated did not differ significantly among either phakic or pseudophakic patients who received standalone stent implantation and patients who underwent combined surgery. However mean latency between primary stent implantation and first revision surgery after combined surgery was markedly shorter.

Five-year outcomes of ab interno Xen 45 gel stent implantation.

BACKGROUND: To assess the safety and 5-year efficacy of ab interno XEN 45 gel stent implantation with phacoemulsification in primary open-angle glaucoma (POAG). METHODS: Single-centre, single-surgeon, retrospective case note review of consecutive OAG patients who underwent ab-interno gel stent placement combined with phacoemulsification. Surgeries were performed between 2/01/2014 and 2/01/2016. PRIMARY OUTCOME MEASURES: mean reduction in intraocular pressure (IOP) and change in number of ocular hypotensive medications from baseline (follow-up range 1-7 years; mean 54 months). SECONDARY OUTCOME MEASURE: change in visual field mean deviation (VFMD) from baseline. Safety data included intraoperative and post-operative complications and adverse events. Failure was defined by IOP reduction < 20% despite maximum medical therapy, the need for further laser or surgical intervention. At 5 years, 75% of eyes were free from failure (95% CI 64 to 83%). RESULTS: Ninety-one eyes were analysed. Mean (SD) IOP and medications decreased from 20.2 (6.4) mmHg and 2.9 (1.0) at baseline to 15.4 (3.6) mmHg (p < 0.001) and 1.5 (1.4) medications at 5 (p < 0.001) years. Baseline mean VFMD (SD) was - 10.3dB (8.5) reducing to - 10.9(8.2) (p < 0.01) at 5 years. Two (2%) eyes had intraoperative complications, 4 (4.3%) experienced post-operative AEs, and 13 (14%) required secondary surgical intervention (SSI). CONCLUSION: The gel stent combined with phacoemulsification was effective in reducing IOP and medications over 5 years, with an acceptable safety profile. Visual field change was clinically acceptable through the study period.

Minimally invasive micro sclerostomy (MIMS) procedure in the treatment of open-angle glaucoma.

BACKGROUND: To evaluate the safety and efficacy of the Minimally Invasive Micro Sclerotomy (MIMS) procedure in the management of uncontrolled open-angle glaucoma. METHODS: A prospective, open-label, single-arm clinical evaluation with intra-subject comparisons performed at the Ophthalmologic Center after S.V. Malayan, Yerevan, Armenia. Included were adults with primary open-angle glaucoma (OAG) (N = 114) or exfoliative glaucoma (N = 6) who were uncontrolled (IOP > 21) on tolerated topical medication. Mild (N = 7), moderate (N = 66) and severe (n = 47) cases were prospectively included without preselection. Following subconjunctival Mitomycin C, an ab-interno MIMS procedure was performed alone (N = 100) or combined with phacoemulsification (N = 20). Patients were followed for 52 weeks. Procedure-related complications and adverse events were recorded. Success criteria were defined as -5 < IOP ≤ 21mmHg OR a reduction in IOP of ≥ 20% from baseline with (qualified success) or without (complete success) hypotensive medications. RESULTS: Mean patient age was 69 ± 10.1 years. The mean duration of the procedure was 2:01 ± 0:41 min:sec. Scleral drainage channels were achieved in all cases. No device malfunctions, intraoperative complications, or serious adverse events were reported. Iris plugging of the sclerostomy site and early spikes in IOP were the most common adverse events. The only reason for failure was final IOP > 21 mmHg on tolerated medication. At 52 weeks (n = 93), mean IOP decreased by 38% from baseline (P < 0.001), from 27.9 ± 3.7 to 17.5 ± 5.3 mmHg, a difference of 10.5 mmHg (95% CI: -11.7, -9.3). One-year qualified success was documented in 82.1% (95% CI: 72.9%,89.2%) of the patients and complete success, in 70.5% (60.3-79.4%). 60% (95 CI:49.4%,69.9%) of the patients achieved maximum IOP level of 14 mmHg or at least 30% reduction in IOP. CONCLUSIONS: MIMS procedure is a relatively simple, short and safe minimally invasive bleb-forming procedure. Its efficacy, as found in this short-term evaluation, lends it suitable for mild and moderate uncontrolled open-angle glaucoma patients. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04503590 2019-05-29.

Long-term efficacy and safety of XEN-45 gel stent implantation in patients with normal-tension glaucoma.

BACKGROUND: Minimally invasive bleb surgery using the XEN-45 gel stent has not been established for the treatment of normal-tension glaucoma (NTG). The main objective of this study was to evaluate the long-term treatment efficacy and safety of XEN-45 in eyes with uncontrolled NTG. METHODS: A retrospective analysis of patients with NTG who underwent XEN-45 gel stent implantation at university hospital Tuebingen between 2016 and 2021. The primary outcome measure was surgical success after three years defined as lowering of intraocular pressure (IOP) of ≥ 20%, with target IOP between 6 and 15 mmHg. Success was complete without and qualified irrespective of topical antiglaucoma medication use. The need for further glaucoma surgery, except for needling, was regarded as a failure. The secondary outcome measures included changes in mean IOP, number of antiglaucoma medications, and needling and complication rates. RESULTS: Twenty-eight eyes from 23 patients were included in the final analysis. Complete and qualified success rates were 56.5% and 75% after three years, respectively. Mean postoperative IOP ± standard deviation decreased significantly after three years from 19.3 ± 2.0 mmHg at baseline to 13.7 ± 4.2 mmHg (n = 22; p < 0.0001). The median number of antiglaucoma medications decreased from 2 (range 0-4) to 0 after three years (range 0-3; p < 0.0001). Sixteen eyes (57%) required a median of 1 (range 1-3) needling procedures. One eye required further glaucoma surgery. No sight-threatening complications were observed. CONCLUSION: The XEN-45 stent is effective and safe for the long-term treatment of NTG. However, needling was frequently required to improve outcomes.

Transient anterior subcapsular vacuolar lens opacities after Tanito microhook trabeculotomy: report of six cases.

OBJECTIVE: To present six cases exhibiting transient anterior subcapsular vacuolar lens opacities following early postoperative Tanito microhook trabeculotomy (TMH) performed by the same surgeon. METHODS: Six patients who underwent lens-sparing TMH at Meizankai Shimizu Eye Clinic from November 2021 to May 2023, and developed anterior subcapsular vacuolar lens opacities postoperatively were reviewed. Detailed records of surgeries, follow-up findings were collected and reported. RESULTS: In all six cases, anterior vacuolar subcapsular lens opacities were observed on the day after surgery, gradually decreasing without affecting visual acuity or contrast sensitivity. In all cases, without any specific interventions, the opacities disappeared by 21 months postoperatively. CONCLUSION: Anterior subcapsular cataracts, characterized by a vacuolar appearance and transient existence, should be recognized as an early complication of ab interno glaucoma surgery, possibly linked to use of distributed ophthalmic viscosurgical devices and excessive anterior chamber irrigation leading to traumatic cataracts on the lens surface.

Matched case-control comparison of surgical success after XEN45 Gel Stent and PRESERFLO MicroShunt implantation in a Caucasian population.

BACKGROUND: The aim of this study was to compare the outcome of implantation of a XEN45 Gel Stent with the outcome of implantation of a Preserflo MicroShunt in a matched-pair analysis in eyes being naïve to filtering surgery. METHODS: In this comparative, retrospective study, 50 eyes that had undergone XEN45 Gel Stent implantation were compared with 50 eyes after Preserflo implantation. Follow-up was at least 6 months, and surgical success was measured by criteria A (IOP < 21 mmHg, IOP reduction >20%, no repeat surgery); criteria B (IOP < 18 mmHg, IOP reduction >20%, no repeat surgery); and criteria C (IOP ≤15 mmHg, IOP reduction ≥40%, no repeat surgery). RESULTS: After a follow-up period of 12 months, mean IOP had decreased from preoperative 25.2 ± 4.8 mmHg in the XEN group to 14.5 ± 4.0 (n = 35) and from 25.3 ± 6.8 mmHg to 11.9 ± 2.9 (n = 41) in the Preserflo group, respectively. The IOP at the last follow-up of the two groups differed significantly (p < 0.01). The probability of surgical success did not differ concerning Criteria A and B, but surgical success was significantly higher in the Preserflo group for Criteria C (60%, p < 0.01). CONCLUSION: Both the Preserflo and XEN45 Gel Stent provide an effective and safe treatment option for advanced glaucoma and have a high potential to reduce intraocular pressure. Absolute IOP levels of <16 mmHg after 12 months were significantly more frequent in the Preserflo group.

Long-term effectiveness and safety of XEN45 in open-angle glaucoma patients.

BACKGROUND: To investigate the long-term effectiveness and safety of XEN45 implant, either alone or in combination with phacoemulsification, in eyes with open-angle glaucoma (OAG). METHODS: Retrospective and single center study conducted on consecutive OAG patients who underwent a XEN45 implant between February-2017 and December-2021. The primary endpoint was the mean intraocular pressure (IOP) lowering from preoperative values. Surgical success was defined as an IOP-lowering from preoperative values ≥ 20% and an IOP absolute value between 6 and 13 mm Hg, without (Complete-success) or with (Qualified-success) antiglaucoma medications. RESULTS: A total of 158 eyes (34 (21.5%) eyes XEN-solo and 124 (78.5%) XEN + Phaco) were included. The median follow-up time was 28.5 months. In the overall study population, the mean preoperative IOP was significantly lowered from 19.4 ± 6.5 mm Hg to 12.4 ± 5.0 mm Hg. The mean preoperative (95% confidence interval) IOP was significantly lowered from 21.3 (19.3-23.2) mm Hg and 18.8 (17.7-20.0) mm Hg to 12.0 (10.4-13.6) mm Hg and 12.5 (11.6-13.5) mm Hg in the XEN-Solo and XEN + Phaco groups, respectively (p < 0.0001 each, respectively). The mean number of ocular-hypotensive medications was significantly reduced in the overall study sample (from 3.4 ± 0.9 to 0.9 ± 1.3, p < 0.0001), XEN-Solo (from 3.5 ± 1.1 to 0.6 ± 1.0, p < 0.0001, and XEN + Phaco (from 3.4 ± 1.1 to 0.9 ± 1.3, p < 0.0001) groups. Eighty-four (53.2%) eyes were categorized as success, with 49 (58.3%) classified as complete success. Eighty-one (51.3%) eyes underwent needling and 15 (9.5%) eyes required an additional surgical procedure. One (0.6%) eye had endophthalmitis. CONCLUSION: XEN implant, either alone or in combination with phacoemulsification significantly lowered IOP and reduced the need of ocular-hypotensive medication, while maintaining a good safety profile.

FP and EP2 prostanoid receptor agonist drugs and aqueous humor outflow devices for treating ocular hypertension and glaucoma.

Prostaglandin (PG) receptors represent important druggable targets due to the many diverse actions of PGs in the body. From an ocular perspective, the discovery, development, and health agency approvals of prostaglandin F (FP) receptor agonists (FPAs) have revolutionized the medical treatment of ocular hypertension (OHT) and glaucoma. FPAs, such as latanoprost, travoprost, bimatoprost, and tafluprost, powerfully lower and control intraocular pressure (IOP), and became first-line therapeutics to treat this leading cause of blindness in the late 1990s to early 2000s. More recently, a latanoprost-nitric oxide (NO) donor conjugate, latanoprostene bunod, and a novel FP/EP3 receptor dual agonist, sepetaprost (ONO-9054 or DE-126), have also demonstrated robust IOP-reducing activity. Moreover, a selective non-PG prostanoid EP2 receptor agonist, omidenepag isopropyl (OMDI), was discovered, characterized, and has been approved in the United States, Japan and several other Asian countries for treating OHT/glaucoma. FPAs primarily enhance uveoscleral (UVSC) outflow of aqueous humor (AQH) to reduce IOP, but cause darkening of the iris and periorbital skin, uneven thickening and elongation of eyelashes, and deepening of the upper eyelid sulcus during chronic treatment. In contrast, OMDI lowers and controls IOP by activation of both the UVSC and trabecular meshwork outflow pathways, and it has a lower propensity to induce the aforementioned FPA-induced ocular side effects. Another means to address OHT is to physically promote the drainage of the AQH from the anterior chamber of the eye of patients with OHT/glaucoma. This has successfully been achieved by the recent approval and introduction of miniature devices into the anterior chamber by minimally invasive glaucoma surgeries. This review covers the three major aspects mentioned above to highlight the etiology of OHT/glaucoma, and the pharmacotherapeutics and devices that can be used to combat this blinding ocular disease.

XEN® implantation: an effective strategy to stop glaucoma progression despite prior minimally invasive glaucoma surgery.

PURPOSE: The aim of this study was to evaluate whether XEN® implantation is a reasonable and safe method to lower the intraocular pressure (IOP) and amount of medication for adult primary open-angle glaucoma (POAG) over a 3-year period. The influence of the type of anesthesia, previous glaucoma surgery, and postoperative interventions on the outcome were examined. METHODS: In this retrospective study, 96 eyes were included. XEN® implantation was performed as sole procedure under general (n = 86) or local anesthesia (n = 10). IOP and number of glaucoma medication were assessed preoperatively: day 1, week 6, month 3, 6, 12, 24, and 36. Further outcome parameters were Kaplan-Meier success rates, secondary intervention, and complication rates. RESULTS: IOP decreased from 20.7 ± 5.1 to 12.8 ± 2.5 mmHg at the 36-month follow-up (p < 0.001) and glaucoma therapy was reduced from 3.3 ± 0.8 to 1.2 ± 1.6 (36 months, p < 0.001). Transient postoperative hypotony was documented in 26 eyes (27.1%). General anesthesia resulted in a significant improvement of the survival rate compared to local anesthesia (77% vs. 50%, p = 0.044). Prior iStent inject®, Trabectome®, or SLT laser had no significant impact, such as filter bleb revision. The number of postoperative needlings had a significantly negative influence (p = 0.012). CONCLUSION: XEN® implantation effectively and significantly lowers the IOP and number of glaucoma therapy in POAG in the 36-month follow-up with a favorable profile of side effects and few complications. In case of IOP, general anesthesia has a significant positive influence on the survival rate, whereas prior SLT or MIGS does not have significant impact.

Risk factors of surgical failure in combined phacoemulsification and excisional goniotomy for angle-closure glaucoma.

PURPOSE: To evaluate the therapeutic success, and risk factors for combined phacoemulsification and Kahook Dual Blade excisional goniotomy (Phaco/KDB) in primary angle-closure glaucoma (PACG). METHODS: A retrospective review was conducted on glaucoma patients who underwent Phaco/KDB between September 2019 and August 2021 at 2 ophthalmology centers. Complete success was defined as unmedicated intraocular pressure (IOP) ≤ 18 mmHg with no further glaucoma surgery, while the medicated IOP ≤ 18 mmHg was defined as qualified success with lesser medications than at baseline. RESULTS: Seventy-two eyes (64 patients) with a mean age of 67.1 ± 8.1 years were included in this study, and 70.2% were female. The mean medicated baseline IOP decreased from 23.4 ± 8.1 to 16.6 ± 3.9 mmHg at an average of 11.6 ± 3.7 months of follow-up (- 29.1%; P < 0.00). Medications decreased from 2.6 ± 1.3 to 0.4 ± 0.9 (- 82.6%; P < 0.001). Complete success and qualified success were achieved in 65.3% and 79.2% of eyes, respectively. Male gender [hazard ratio (HR): 6.00 (1.57-22.9); P = 0.009] was observed a risk factor for surgical failure, whereas higher axial length (HR:0.37 (0.16-0.86); P = 0.021), and a combined circumferential goniosynechialysis procedure (HR: 0.13 (0.02-0.74); P = 0.022) lowered the risk of surgical failure. Hyphema, postoperative shallowing anterior chamber, and IOP spike were the most common complications. The cumulative survival proportion for qualified success at 12 months was 82.5% ± 0.05 (95% CI, 0.70-0.90). CONCLUSION: Phaco/KDB provided acceptable therapeutic success rate and may, therefore, be recommended in patients with coexisting cataract and PACG. Identifying patients with risk factors preoperatively may help clinicians predict surgical success.

Results of open bleb revision as management of primary bleb failure following XEN 45 gel stent and Preserflo™ Microshunt.

PURPOSE: The success of filtering surgery as in XEN-Gel-Stent (XEN) and Preserflo-Microshunt (PF) depends mainly on a functioning bleb. Primary bleb failure (PBF) is not uncommon and can be treated with needling or open bleb revision (OBR). The aim of the study is to compare surgical outcomes of OBR after XEN and PF. METHODS: Eyes which received OBR as management of PBF following implantation of XEN or PF were retrospectively included. Intraocular pressure (IOP), number of IOP lowering medications (NoM), and success rates (SR) were compared between groups. Complete and qualified success were defined as IOP ≤18mmHg and a reduction of >20%, without and with medications, respectively. RESULTS: 29 eyes after XEN and 23 eyes after PF were included. Six months following OBR, IOP reduced from 24.2±4.7 to 13.5±4.6 after XEN and from 27.3±8.7 to 15.9±5.8mmHg after PF (both p<0.001). NoM did not change (0.7±1.3 to 0.4±0.8 after XEN and 1.2±1.3 to 1.0±1.5 after PF, p>0.05 for both). Complete SR were higher after XEN than after PF (58.6% vs. 30.4%, p=0.04). Complications were mild and managed mainly conservatively. Additional glaucoma surgery was needed in 17% and 30% of eyes after XEN and PF, respectively (p=0.26). CONCLUSION: Although OBR was effective as management of PBF following XEN and PF, SR were higher after XEN than after PF along with comparable safety profile. The change of the surgical approach from ab interno during XEN-Implantation to ab externo during OBR seems to enhance SR compared to PF, where both interventions are done ab externo.

Five-year follow-up of corneal endothelial cell density after transscleral ab interno glaucoma gel stent implantation.

PURPOSE: This study investigates the course of the endothelial cell density over a period of 5 years after XEN45 implantation (XEN45µm, Allergan Plc., USA) with or without combined cataract surgery. METHODS: This is a prospective, cross-sectional, monocentric, non-randomized clinical trial with the intention to treat a population of the University Eye Clinic Glaucoma Service Salzburg. One hundred and fifty-five eyes with preoperative central corneal endothelial cell counts were subjected to XEN45 implantation with (combined surgery group) or without (solo surgery group) combined cataract surgery. Endothelial cell density was measured at 3 corneal positions. XEN45 location parameters were determined with anterior segment OCT and gonioscopy. RESULTS: In the combined surgery group, a significant reduction of central endothelial cell count was found at years 2 and 4 when compared to baseline (p = 0.001 and p = 0.02, n = 86), whereas at years 1, 3, and 5, no change was detected (all p > 0.09). The median reduction of endothelial cell count was - 79 (95% CI: - 183 to - 9) and - 93 (95% CI: - 220 to 23) cells at years 2 and 4, respectively. In the solo surgery group (n = 69), no significant change in endothelial cell counts was detected at any time during the 5-year evaluation period (all p > 0.07). Explorative data analyses revealed that XEN45 location parameters did not significantly influence the course of endothelial cell count over time. CONCLUSIONS: Endothelial cell loss after XEN45 implantation seems to be low. The present data suggest no impact on the position of the implant with regard to central endothelial cell counts in this study.

Risk factors for ocular hypotony after XEN Gel Stent implantation.

PURPOSE: To investigate the incidence of postoperative hypotony, and risk factors for the development of hypotony in eyes who had undergone XEN Gel Stent implantation. METHODS: In this retrospective, single-centre case series, medical records of 170 consecutive eyes who had undergone XEN Gel Stent implantation with or without simultaneous phacoemulsification for primary or secondary open angle glaucoma were analysed. Primary outcome parameters were the incidence of postoperative hypotony and potential risk factors for its development, and secondary parameters were pre- and postoperative visual acuity, intraocular pressure (IOP), and number of IOP-lowering eye drops. RESULTS: Postoperative hypotony ≤ 6 mmHg occurred in 57% of eyes. Hypotony was without complications in 70.1%, 13.4% had transient complications with spontaneous resolution, and 16.5% had complications requiring treatment. Mean visual acuity logMAR before surgery accounted for 0.47 ± 0.46 in all eyes and 0.47 ± 0.48 at the 4-week visit. There was no significant difference of BCVA in the group of eyes with and without postoperative hypotony before and after surgery. The mean IOP before surgery was 24.6 ± 8.4 mmHg and decreased significantly to 18.4 ± 10.2 after 4 weeks. Eyes with an axial length over 24.3 mm had a threefold increased risk for postoperative hypotony (OR 3.226, 95% confidence interval 1.121-9.279). This risk was decreased in eyes with simultaneous cataract surgery (OR 0.483, 95% confidence interval 0.258-0.903). CONCLUSION: In our sample, postoperative hypotony was a common complication after XEN Gel Stent implantation, but serious, persistent complications were rare. A longer axial length predisposes the eye for the development of hypotony.

Glaucoma medical treatment as a predictor of XEN45 subconjunctival gel implant hypotensive efficacy.

PURPOSE: The aim of this study was to determine the preoperative characteristics influencing hypotensive efficacy of the XEN45 gel stent in patients with open-angle glaucoma at one-year follow-up. MATERIALS AND METHODS: This was a retrospective multicentre study. All patients who underwent XEN45 gel stent implantation between January 2017 and January 2021 were included. The main study outcome was the assessment of one-year postoperative intraocular pressure (IOP) and glaucoma medication differences according to the number and type of preoperative topical treatments or glaucoma surgery, glaucoma stage and time since diagnosis. Follow-up period was 1-year post-surgery in all cases. IOP reduction and surgery success (not requiring reoperation or pressure failures [IOP > 18 mmHg and < 20% reduction in IOP]), safety and cost savings in topical glaucoma therapy after surgery were secondarily assessed. Linear regression analysis to determine the preoperative parameters influence on 1-year postoperative results was performed. RESULTS: XEN45 gel stent was implanted in 85 patients. One-year postoperative mean IOP dropped from 20.6 ± 4.1 to 13.7 ± 2.8 mmHg (p < 0.0001). Likewise, mean number of topical treatments decreased from 2.05 ± 0.9 to 0.36 ± 0.65 (p < 0.001). Both were mainly influenced by the number of preoperative glaucoma treatments, such that for each one-glaucoma medication increase, postoperative intraocular pressure increased by 1.18 mmHg (95% CI 0.56-1.79, p < 0.0001) and number of glaucoma medications increased by 0.3 (95% CI 0.16-0.43, p < 0.001). Overall success rates (with and without supplemental glaucoma medication use) were 97.6% (95% CI 94.5-100%), 87.1% (95% CI 80.2-87.1%) and 61.2% (95% CI 51.6-72.5%) at 3, 6 months and 1 year after surgery. No sight-threatening adverse events were reported. Mean annual cost savings on medical treatment since surgery reached EUR 251.19 ± 169. 93 euros. CONCLUSIONS: One year after surgery, XEN45 gel implant significantly reduced IOP and number of topical medications with an adequate safety profile being both mainly influenced by the number of preoperative glaucoma treatments.

Hemi-GATT combined with phacoemulsification in patients with moderate-severe primary open-angle glaucoma: 2-year outcomes.

PURPOSE: To describe the outcomes of inferior hemisphere 180° gonioscopy-assisted transluminal trabeculotomy (hemi-GATT) in patients with moderate-severe stage primary open-angle glaucoma (POAG). METHODS: This single center, retrospective study identified patients with POAG who had undergone combined inferior hemi-GATT with phacoemulsification. Patients with moderate-severe staged POAG were included in the study. Outcome measures included surgical success, intraocular pressure (IOP), number of topical IOP-lowering drops, best-corrected visual acuity (BCVA), visual field mean deviation (MD) and complications. Success was defined using two criteria: Criterion A (IOP <17 mmHg and >20% reduction) and Criterion B (IOP <12 mmHg and >20% reduction). RESULTS: One hundred-twelve eyes of 112 patients were included in this study. Of these, 91 patients were followed for 24 months or greater to assess endpoint surgical success. Kaplan-Meier survival analysis for Criterion A demonstrated a 64.8% probability of success without topical IOP-lowering therapy (complete success) and a 93.4% probability of success with or without topical IOP-lowering therapy (qualified success). Probabilities of complete and qualified success using Criterion B were 26.4% and 30.8%, respectively. IOP reduction from baseline (21.9 ± 5.8 mmHg) to 24-month follow-up (13.6 ± 3.9 mmHg) was 37.9% for the overall cohort. The most common complication was transient hyphema, which occurred in 25.9% (29 of 112) of patients. All cases of hyphema resolved spontaneously. CONCLUSIONS: Combined hemi-GATT with phacoemulsification was associated with favorable outcomes and a low complication rate in this study of patients with moderate-severe POAG. Further studies are required comparing hemi-GATT to the 360° approach.

IOP-lowering and drug-sparing effects of trabectome surgery with or without cyclodialysis ab interno.

PURPOSE: To compare the postoperative intraocular pressure (IOP) after ab interno trabeculectomy (AIT; trabectome surgery) alone or combined with cyclodialysis ab interno (AITC). PATIENTS AND METHODS: Forty-three eyes with insufficiently controlled open-angle glaucoma were included in this consecutive case series. All eyes received AIT, combined with phacoemulsification and IOL-implantation in phakic instances, with or without additional cyclodialysis ab interno. Postoperative visual acuity, IOP, number of IOP-lowering medications and complications were registered over 12 months. RESULTS: A total of 19 eyes (14 patients) received AIT and 24 (19 patients) received AITC. Both groups were comparable for baseline IOP (AIT: 19.7 ± 8.2 mmHg; AITC: 19.4 ± 6.8 mmHg; p = 0.96), there was a comparable IOP reduction after 6 months (AIT: - 3.8 ± 12.3, median (interquartile range (IQR)): - 3.8 (- 7.8-4.8) mmHg; AITC: - 4.9 ± 8.3, median (IQR): - 2.0 (- 10.8-2.0) mmHg; p = 0.95) and 12 months (AIT: - 4.3 ± 6.6, median (IQR): - 4.0 (- 8.0 to - 1.0) mmHg; AITC: - 3.7 ± 6.7, median (IQR): - 1.5 (- 5.5 to - 0.5) mmHg; p = 0.49). While final visual acuity was similar between the groups, they differed regarding topical IOP-lowering medications (baseline: AIT 2.9 ± 1.2 and AITC 2.9 ± 1.2; 1 year after surgery: AIT 2.6 ± 1.5 (p = 0.16) and AITC 1.3 ± 1.3; p < 0.001)). Depending on the definition, a complete or qualified success of 33.4-45.8% was achieved in AITC compared to 15.8-21.1% in AIT. CONCLUSION: The additional suprachoroidal outflow when AIT is combined with cyclodialysis ab interno (AITC) seems to result in an additional drug sparing effect for at least 1 year without critical safety signals. Thus, AITC might be further investigated prospectively prior to advocating its use in routine minimally invasive glaucoma surgery.

A multicenter prospective comparative study evaluating cataract surgery and endoscopic cyclophotocoagulation either with or without iStent inject implantation in Brazilian patients with glaucoma.

PURPOSE: Compare 12-month (12 M) safety and efficacy of endoscopic cyclophotocoagulation (ECP) + cataract surgery (Group 1) versus ECP + cataract surgery + iStent inject trabecular micro-bypass implantation (Group 2) in Brazilian patients with open-angle glaucoma (OAG). METHODS: This prospective, multicenter, comparative case series included patients with OAG and cataract who were randomized to receive treatment in Group 1 or Group 2. Outcomes included mean and percent reduction versus preoperative in intraocular pressure (IOP) and number of glaucoma medications; visual acuity; occurrence of adverse events; and rate of secondary surgeries. RESULTS: Preoperatively, Groups 1 and 2 had similar mean IOP (mean ± standard deviation 22.1 ± 3.6 and 22.0 ± 2.5 mmHg, respectively) and mean number of medications (3.3 ± 0.6 and 3.4 ± 0.6 medications, respectively). At all follow-up timepoints through 12 M, both groups achieved significant IOP and medication reductions versus preoperative (IOP p < 0.001 and number of medications p < 0.001 for both groups). At 12 M, IOP reductions were 24.2% (Group 1) and 43.6% (Group 2) (p < 0.001); mean medication reductions were 50.2% and 71.5%, respectively. Mean postoperative IOP and number of medications were higher in Group 1 than Group 2 (IOP p < 0.01 all visits, medication p < 0.01 at 6 M and 12 M). Adverse events were generally mild and infrequent in both groups. CONCLUSION: Both treatment groups (ECP + phacoemulsification, with/without iStent inject implantation) achieved significant and safe reductions in IOP and medications versus preoperative in Brazilian OAG patients. Percent reductions were significantly greater, and mean IOP and medications were significantly lower, in the group receiving iStent inject. CLINICAL TRIAL REGISTRATION (CTR): CAAE project identification #20053019.5.0000.5078. Protocol #3.587.147. Clinical Trial Database of the Federal University of Goiás, Brazil. Registration Date: September 19, 2019.

12-month outcomes of ab interno excisional goniotomy combined with cataract surgery in primary open-angle glaucoma and normal tension glaucoma.

PURPOSE: To evaluate the efficacy and safety of excisional goniotomy performed with the Kahook Dual Blade (KDB) combined with cataract surgery in patients with pimary open angle glaucoma (POAG) and Normal Tension Glaucoma (NTG) under topical therapy. Further sub-analysis was performed to compare between 90 and 120 degrees goniotomy. METHODS: This was a prospective case series of 69 eyes from 69 adults (age 78 ± 5.9 years; male = 27, female = 42). Indications for surgery included insufficient IOP control with topical medication, glaucomatous damage progression under topical therapy and reduction of medication burden. Complete success was defined as IOP lowering below 21 mmHg without the need for topical medication. For NTG patients, complete success was defined as IOP lowering below 17 mmHg without the need for topical medication. RESULTS: IOP was significantly lowered from 19.7 ± 4.7 to 15.1 ± 2.7 at 2 months, 15.8 ± 2.3 at 6 months and 16.1 ± 3.2 at 12 months (p < 0.05) for POAG and 15.1 ± 2.5 to 14.1 ± 2.4 at 2 months, 14.1 ± 3.1 at 6 months and 13.6 ± 1.8 at 12 months (p > 0.08) for NTG, respectively. Complete success was achieved in 64% of the patients. IOP lowering under 17 mmHg without the need for topical medication was achieved in 60% of the patients at 12 months. In NTG patients (14 eyes) IOP lowering under 17 mmHg without the need for topical medication was achieved in 71%. No significant difference was recorded in terms of IOP lowering at 12 months in-between 90° and 120° of treated trabecular meshwork (p > 0.7). No severe adverse reactions were recorded in this study. CONCLUSION: One-year results show that KDB combined with cataract surgery is an effective treatment option for glaucoma patients. IOP lowering was successfully achieved in NTG patients with complete success in 70% of the patients. In our study, no significant differences were recorded in-between 90° and 120° of treated trabecular meshwork.