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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Despite the XEN gel stent low-risk profile, various complications following the implant have been described, including internal and external occlusion, with a consequent postoperative rise in intraocular pressure (IOP). In this case report we aimed to present a XEN45 stent internal occlusion successfully treated by trimming in situ its proximal end with a 25 G vitreous scissors using a bimanual technique.Case Presentation: A 63-year-old male patient affected by primary open angle glaucoma (IOP = 25 mmHg) and a full thickness macular hole in his right eye, underwent ab-interno Xen gel stent implantation and, 1 month later, a 25 G vitrectomy surgery. Despite a significant IOP reduction after stent implant, 6 days after vitrectomy, IOP increased (25 mmHg) and the conjunctival bleb flattened following occlusion of stent internal ostium by a clot of presumed fibrinous material. The Nd:YAG laser failed to remove the clot, so that we decided to snip a small bit of the proximal end of the Xen tube (about 0,5 mm length) with a 25 G vitreous scissors, using a bimanual technique. In the postoperative day 1 and month 1, the IOP was 8 mmHg and 12 mmHg, respectively. The Anterior Segment OCT confirmed a functional, layered, filtering bleb, and the normal appearance and patency of the XEN proximal segment. No side effects from the intervention were observed.Conclusions: Ab interno trimming with vitreous scissors of the occluded proximal end of the XEN stent may represent a safe, rapid and efficient method to restore aqueous humor subconjunctival drainage. [ABSTRACT FROM AUTHOR]

Background: PreserFlo® MicroShunt (PM) (also known as InnFocus® MicroShunt) is a subconjunctival stent implanted ab externo via a minimally invasive surgical procedure. The current indication is progressive, mild to moderate, open angle glaucoma uncontrolled on topical medications. According to the literature, adverse events are rare, mild and transient.Case Presentation: Two cases of stand-alone PreserFlo MicroShunt® implantation in patients with uncontrolled open-angle glaucoma are reported. Exposure occurred 7 days and 3 months respectively after implantation. These cases shared common features including preexisting blepharitis and the lack of a Tenon's flap. In both cases, removal of the device was required after several attempts at repair.Conclusions: PreserFlo MicroShunt® exposure is a potentially vision-threatening complication because of the risk of endophthalmitis. Potential risk factors include the absence of a Tenon's flap and pre-existing ocular surface inflammation. Ocular surface inflammation should be detected and treated prior to PM implantation. If a deficiency in Tenon's capsule is noted intraoperatively, close monitoring should be performed because of the higher risk of PM exposure. [ABSTRACT FROM AUTHOR]

Background: The aim of this retrospective study was to compare the efficacy and safety profile of a single XEN-microstent in different types of primary and secondary open angle glaucoma.Methods: A single XEN microstent was implanted in patients with primary open-angle glaucoma (POAG), normal-tension glaucoma (NTG), pseudoexfoliation glaucoma (PEX) and secondary glaucoma (Sec.Gl). The intraocular pressure (IOP), the active substances of the applied IOP-lowering drugs, the best corrected visual acuity (BCVA) and the mean deviation (MD) of the perimetry were measured at baseline and at regular follow-ups, scheduled at 2 days and 1, 3, 6 and 12 months after surgery.Results: 153 eyes were included in this analysis. 113 eyes were affected by POAG (74%), 5 eyes by NTG (3%), 22 eyes by PEX (14%) and 13 eyes by Sec. Gl (9%). Mean IOP decreased in all treatment groups during the 12 months of follow-up (complete group: 23.9 ± 7.4 to 15.4 ± 5.1 mmHg (p < 0.01); POAG: 22.8 ± 6.5 to 15.1 ± 4.6 mmHg (p < 0.01); NTG: 16.6 ± 3.4 to 11.6 ± 2.2 mmHg (p < 0.05); PEX: 28.0 ± 7.9 to 17.1 ± 6.6 mmHg (p < 0.01); Sec.Gl: 28.9 ± 13.9 to 15.5 ± 6.9 mmHg (p < 0.05)). In the 153 eyes the average number of IOP-lowering drugs applied decreased from 2.6 ± 1.2 to 0.8 ± 1.3 12 months after surgery (p < 0.01). BCVA and mean deviation of automated standard perimetry remained stable in all groups during follow-up.Conclusion: As in eyes suffering from POAG, IOP and number of IOP-lowering drugs applied can be effectively reduced by XEN implantation in eyes suffering from NTG, PEX and secondary glaucoma while leaving BCVA and visual field unchanged.Trial Registration: Trial was registered at DRKS (registration number: DRKS00020800 , Registered 25.February 2020 - Retrospectively registered). [ABSTRACT FROM AUTHOR]

Background: Glaucoma surgery have been developed to lower intraocular pressure in a less invasive manner than traditional glaucoma surgery. The purpose of this article is to determine the outcome of using combined phacoemulsification technique, ab-interno trabeculectomy dual blade and endoscopic cyclophotocoagulation (ECP) surgeries in patients with primary open angle glaucoma.Methods: A retrospective case series was performed on 27 consecutive eyes with both primary open-angle glaucoma (POAG) and cataract; each eye was treated with combined phacoemulsification, ab-interno trabeculectomy-Kahook Dual Blade and Endocyclophotocoagulation at Instituto de ojos Oftalmosalud, Lima, Peru, between April 2017 and May 2017.Inclusion Criteria: 1) Patients with uncontrolled mild to advanced POAG (according to Glaucoma Grading Scale HODAPP) 2) cataract condition 3) treatment with two or more glaucoma medications due to rapid progression in the visual fields (at least two in a short period of time). Intraocular pressure (IOP), best corrected visual acuity (BCVA) logMAR and number of glaucoma medications were recorded prior to the study, at day 1, week 1, and 1,3,6 and 9 months after surgery. Primary outcome measure was surgical success defined in terms of IOP < 14 mmHg either with no medications (complete success) or with medications (qualified success).Results: A total of 27 eyes from 27 patients were included. The mean basal IOP was 17.0 ± 3.7 mmHg and postoperatively was 11.6 ± 1.9 mmHg and 11.4 ± 1.8 mmHg (P < 0.001) at 6 and 9 months respectively. Glaucoma medications decreased from 1.9 ± 1.4 to 0.56 ± 1.05 at 9 month follow-ups (P < 0.001). Preoperative best corrected visual acuity (BCVA) showed and improvement from 0.4 ± 0.4 LogMAR to 0.2 ± 0.4 logMAR at 9 months. The main complication was blood reflux intra-operatively (66.7%), which resolved without re-operation. The mean IOP was reduced by 32.9% from baseline and the surgical success was 92,6%, (complete success 70,3% and qualified success 29,6%) at 9 months.Conclusions: In patients with POAG, combined treatment with phacoemulsification, ab-interno trabeculectomy and endoscopic cyclophotocoagulation effectively reduced IOP and glaucoma medication dependence. [ABSTRACT FROM AUTHOR]

Background: XEN® gel stent (Allergan, Dublin/Republic of Ireland) is a relatively new microinvasive glaucoma device providing an ab-interno approach to the subconjunctival space for aqueous drainage and reduction of intraocular pressure. It is thought to be less invasive, reduce surgical time and post-operative infection rates compared with traditional glaucoma procedures. Little information however, has been published regarding complications and subsequent management.Case Presentation: The authors highlight five complicated cases of XEN® stent insertion, how they were managed and key learning points. Cases include: entire stent found at the bottom of the anterior chamber several months after uncomplicated insertion, stent broke into multiple pieces during manipulation within subconjunctiva, XEN45 stent migrated into the anterior chamber 7 months post-operatively and a case of limbal-based conjunctival dissection during open revision which lead to additional scarring around the stent and subsequent raised intraocular pressure.Conclusions: We present some new and interesting complications of XEN implant as well as potential management options. This can assist clinical decision-making and enable better pre-operative discussions with patients regarding risks of surgery. [ABSTRACT FROM AUTHOR]

Background: XEN glaucoma implant (XEN gel stent, Aquesys, Inc) is a new minimally invasive device approved for the treatment of glaucoma.Case Presentation: A 45 year old female was being followed and treated for primary open angle glaucoma in our tertiary referral center. Due to failure of medical treatment in controlling the glaucoma, surgery was offered to the patient. The XEN 45 μ-fistula implant was successfully placed in both eyes and adequate intraocular pressure control was achieved for 4 months. The left eye pressure then increased and the XEN implant was found in the anterior chamber. Topical intraocular pressure lowering therapy had to be re-initiated to achieve adequate pressure control.Conclusion: We describe a new potential complication of the XEN glaucoma implant. [ABSTRACT FROM AUTHOR]