Two-Year Clinical Outcomes of the PAUL® Glaucoma Implant in White Patients with Refractory Glaucoma.

PRCIS: This prospectively collected case series of 56 eyes having PAUL glaucoma implant surgery is the first to demonstrate its medium term safety and effectiveness in what is essentially an exclusively Caucasian population. BACKGROUND: To report two-year outcomes from a single-center cohort undergoing PAUL® Glaucoma Implant (PGI) surgery. METHODS: Prospectively collected data of patients undergoing PGI surgery at the University Eye Hospital Bonn, Germany, from 04/2021 to 09/2021. RESULTS: 56 eyes of 53 patients were included. Complete and qualified success rates (95% CI) were 52% (37-66) and 89% (80-96) for Criterion A (IOP≤21 mm Hg), 48% (36-61) and 79% (67-88) for Criterion B (IOP≤18 mm Hg), 45% (32-57) and 64% (52-77%) for Criterion C (IOP≤15 mm Hg) and 27% (16-40) and 38% (25-50) for Criterion D (IOP≤12 mm Hg) respectively. Mean IOP decreased from 25.43 mm Hg (7-48 mm Hg) to 11.25 mm Hg (3-24 mm Hg) (reduction of 50%) after 24 months with a reduction of IOP-lowering agents from 3.50 (1-5) to 0.46 (0-3). One eye needed an injection of viscoelastic due to significant hypotony with AC shallowing; 3 eyes received a DMEK due to persistent corneal decompensation; 9 eyes developed tube exposure which required conjunctival revision with additional pericardial patch graft, with 5 of these eyes eventually needing tube explantation. An intraluminal prolene stent was removed in 24 eyes (42.9%) after a mean time period of 5.67 months (2-15 m). Mean IOP before removal was 21.4 mm Hg (12-40 mm Hg) and decreased to 11.15 mm Hg (6-20 mm Hg). CONCLUSIONS: PGI surgery is an effective procedure for reducing IOP and pressure-lowering therapy. The use of an intraluminal prolene stent impedes hypotony in the early postoperative phase and enables further non-invasive IOP lowering during the postoperative course.

[Clinical results of the eyeWatch system: 1-year outcomes]. / Klinische Ergebnisse des eyeWatch-Systems: 1-Jahres-Outcome.

BACKGROUND: The eyeWatch System (EWS) (Rheon Medical, Lausanne, Switzerland) was developed as a glaucoma drainage device (GDD) to precisely control intraocular pressure (IOP) and thus prevent the development of postoperative hypotension and its complications. OBJECTIVE: To report 1­year outcomes from a single-center cohort undergoing EWS surgery. MATERIAL AND METHODS: Retrospective review of patients undergoing EWS surgery at the University Eye Hospital Bonn, Germany from May 2021 to September 2022. RESULTS: A total of 5 eyes of the first 5 consecutive patients treated with the EWS were included in this study. The mean preoperative IOP was 34.6 mm Hg (23-45 mm Hg) which was reduced to 12.2 mm Hg (9-18 mm Hg) with a mean reduction of 60%. Local pressure-lowering therapy was reduced from 2.8 agents preoperatively (1-4) to 0.6 agents after 1 year. All patients achieved the target IOP of below 21 mm Hg including 4 patients without any medication. The complication rate was low. One patient had to undergo two surgical revisions as the IOP was elevated to over 30 mm Hg after surgery and tube exposure became apparent during the course of the follow-up so that a second donor patch was sutured on. The same patient had an elevated IOP >30 mm Hg after a cMRI examination, so that a reduction of IOP by adjusting the EWS using the eyeWatch pen (EWP) was performed. IOP adjustments with the eyeWatch pen (EWP) were performed in 4 of 5 patients in the first year after surgery; the mean IOP before adjustment was 21.33 mm Hg (15-37 mm Hg) which was reduced to a mean of 8.58 mm Hg (4-16 mm Hg). CONCLUSION: The EWS effectively lowers IOP and the amount of necessary pressure-lowering therapy. With the EWP postoperative adjustments of IOP are possible without further invasive measures.

Knowledge about age-related eye diseases in the general population in Germany.

BACKGROUND: With a rising prevalence of age-related eye diseases, prevention and early diagnosis of these conditions are key goals of public eye health. Disease-related knowledge in the general public supports these goals but there is little data available. Thus, we have assessed knowledge of cataract, glaucoma, age-related macular degeneration (AMD) and diabetic eye disease in the German adult general population in a cross-sectional study and identified target groups for health education interventions. METHODS: Knowledge assessment content was identified based on a literature review, expert input, and a list of items was generated after a qualitative selection process. The resulting 16-item instrument (4 items per condition) was administered to 1,008 participants from a survey panel, demographically representative of the adult German population. Test properties were evaluated based on a Rasch model and multiple correspondence analysis (MCA). Binary-logistic regression analysis was performed to investigate associations with age, sex, education level, employment status, marital status, income, reported health status, visual difficulties, and recent general practitioner (GP) and ophthalmologist consultations. RESULTS: Replies were correct for a median of 9 out of 16 (range 2 - 16) items, which differed between conditions (p < 0.0001). Most responses were correct for cataract items (median: 3 / 4) and least were correct for AMD items (median: 2 / 4). 27%, 9%, 1% and 19% of respondents replied correctly to all cataract, glaucoma, AMD and diabetic eye disease-related items, respectively. Rasch analysis suggested an adequate targeting of items and in MCA, no evidence of multidimensionality was present. Older age, being retired, decreased general health and recent GP or ophthalmology consultations were significantly associated with more knowledge about common eye conditions (p ≤ 0.005). GP or ophthalmology consultations remained significant in a multivariable model (p ≤ 0.011). CONCLUSIONS: Knowledge gaps regarding eye health are considerable in the German general population and should therefore be addressed in educational interventions targeting the public. Special attention when designing such campaigns needs to be paid to infrequent users of the healthcare system. Knowledge of AMD seems to be poorer compared to other eye conditions.

Ocular drug delivery systems: glaucoma patient perceptions from a German university hospital eye clinic.

PURPOSE: This study aimed to report on glaucoma patients' beliefs and illness perceptions and to investigate their opinion on ocular drug delivery devices (ODD). METHODS: We performed a cross-sectional study in a large tertiary-referral outpatient glaucoma clinic, with 102 patients. Validated anonymized questionnaires were used. We investigated the awareness and acceptance regarding ODD (contact lenses (CLs), punctal plugs (PPs), subconjunctival implants, anterior chamber (AC) injections, and drug-emitting stents) and looked at factors that could influence a patient's decision for having an ODD. RESULTS: Sixty-three patients (61.8%) confirmed they would rather have ODD than keep their eye-drops (38.2%). The most important factors influencing their decision were effectiveness and long-lasting effect. A large proportion of patients reported a preference for CLs (48.0%), PPs (52.9%), or drug-emitting stents (44.1%). When comparing patients who preferred ODD (group-1) versus eye-drops (group-2), significantly more patients in group-1 were worried (p < 0.001) or felt disrupted (p < 0.001) by their use of eye-drops. A significantly greater share of patients in group-1 showed acceptance towards CLs (60.3% vs. 38.5%; p = 0.032), AC injections (38.1% vs. 12.8%, p = 0.006), or drug-emitting stents (54% vs. 28.2%, p = 0.023), whilst there were no significant differences regarding the acceptance of PPs (p = 0.363) or subconjunctival implants (p = 0.058). CONCLUSION: ODD for the treatment of glaucoma were broadly deemed acceptable by patients in this study. Effectiveness and long-lasting effect were the most important factors for a decision towards having an ODD. The majority of patients who preferred an ODD felt severely affected by their disease and were negatively influenced by their glaucoma medication intake.

Risk Factors for Failure in Glaucoma Patients Undergoing Microshunt Implantation.

PURPOSE: To evaluate risk factors for failure of Microshunt in glaucoma patients. DESIGN: Multicenter retrospective cohort study. METHODS: The study included 220 eyes from 220 consecutive glaucoma patients undergoing Microshunt implantation at six glaucoma units. Four intraocular pressure (IOP) success criteria were defined: (A) IOP ≤21 mm Hg with ≥20% IOP reduction; (B) IOP ≤18 mm Hg with ≥20% IOP reduction; (C) IOP ≤15 mm Hg with ≥25% IOP reduction; and (D) IOP ≤12 mm Hg with ≥30% IOP reduction from baseline. Kaplan-Meier analysis was used to estimate success rates according to the criteria above, and multivariable Cox models were used to identified risk factors for failure according to criterion A. RESULTS: Success rates varied based on different criteria, ranging from 43.3% to 62.5% (overall success for criteria D and A, respectively) and from 35.3% to 44.4% (complete success for criteria D and A, respectively) at 1-year follow-up. Higher intraoperative MMC concentration was associated with reduced risk of failure to maintain complete (0.4 vs 0.2 mg/mL: hazard ratio [HR] = 0.441, P < .001) and overall (0.4 vs 0.2 mg/mL: HR = 0.360, P = .004) success. For complete success, other risk factors for failure were pseudoexfoliation glaucoma/pigmentary glaucoma (HR = 1.641, P = .004), primary angle closure glaucoma (HR = 1.611, P < .001), and previous non-glaucomatous ocular surgeries (HR = 2.301, P = .002). For overall success, other risk factors for failure were lower preoperative IOP (for 1-mm Hg increase, HR = 0.934, P = .005), higher number of preoperative antiglaucoma agents (HR = 1.626, P < .001), and Microshunt combined with cataract surgery (HR = 1.526, P = .033). CONCLUSIONS: This study identified risk factors for Microshunt failure, highlighting the importance of high intraoperative MMC dose and careful patient selection to optimize surgical success.

Minimally Invasive Glaucoma Surgery: Latest Developments and Future Challenges.

The development of minimally invasive glaucoma surgeries (MIGSs) was intended to provide safe and modestly efficacious modalities for early intervention of mild-to-moderate glaucoma, with minimal trauma and rapid recovery. They were mainly ab interno procedures that reduce intraocular pressure by facilitating the aqueous outflow by bypassing the trabecular meshwork resistance, reinforcing the uveoscleral flow via the supraciliary space, and reducing aqueous production by the ciliary body. While the cumulating evidence helps shape the role of the available MIGS, the exponential new development and advancement in this field has expanded the territory of MIGS. Apart from developing subconjunctival MIGS filtration devices (Xen gel stent and PRESERFLO MicroShunt), there is a tendency to revisit the "traditional" MIGS for alternative use and to modify the procedures with consideration of the fundamental aqueous outflow physiology. Combined MIGS has also been suggested, based on the theory that their different mechanisms may provide additive or synergistic effects. The advancement of laser procedures is also promising and could supplement unmet needs along the glaucoma treatment algorithm. This review examines the broad array of MIGS, updates the recent findings, discusses their potential alternative applications, and explores future challenges.

European Glaucoma Society - A guide on surgical innovation for glaucoma.

PROLOGUE: Glaucoma surgery has been, for many decades now, dominated by the universal gold standard which is trabeculectomy augmented with antimetabolites. Tubes also came into the scene to complement what we use to call conventional or traditional glaucoma surgery. More recently we experienced a changing glaucoma surgery environment with the "advent" of what we have become used to calling Minimally Invasive Glaucoma Surgery (MIGS). What is the unmet need, what is the gap that these newcomers aim to fill? Hippocrates taught us "bring benefit, not harm" and new glaucoma techniques and devices aim to provide safer surgery compared to conventional surgery. For the patient, but also for the clinician, safety is important. Is more safety achieved with new glaucoma surgery and, if so, is it associated with better, equivalent, or worse efficacy? Is new glaucoma surgery intended to replace conventional surgery or to complement it as an 'add-on' to what clinicians already have in their hands to manage glaucoma? Which surgery should be chosen for which patient? What are the options? Are they equivalent? These are too many questions for the clinician! What are the answers to the questions? What is the evidence to support answers? Do we need more evidence and how can we produce high-quality evidence? This EGS Guide explores the changing and challenging glaucoma surgery environment aiming to provide answers to these questions. The EGS uses four words to highlight a continuum: Innovation, Education, Communication, and Implementation. Translating innovation to successful implementation is crucially important and requires high-quality evidence to ensure steps forward to a positive impact on health care when it comes to implementation. The vision of EGS is to provide the best possible well-being and minimal glaucomainduced visual disability in individuals with glaucoma within an affordable healthcare system. In this regard, assessing the changes in glaucoma surgery is a pivotal contribution to better care. As mentioned, this Guide aims to provide answers to the crucial questions above. However, every clinician is aware that answers may differ for every person: an individualised approach is needed. Therefore, there will be no uniform answer for all situations and all patients. Clinicians would need, through the clinical method and possibly some algorithm, to reach answers and decisions at the individual level. In this regard, evidence is needed to support clinicians to make decisions. Of key importance in this Guide is to provide an overview of existing evidence on glaucoma surgery and specifically on recent innovations and novel devices, but also to set standards in surgical design and reporting for future studies on glaucoma surgical innovation. Designing studies in surgery is particularly challenging because of many subtle variations inherent to surgery and hence multiple factors involved in the outcome, but even more because one needs to define carefully outcomes relevant to the research question but also to the future translation into clinical practice. In addition this Guide aims to provide clinical recommendations on novel procedures already in use when insufficient evidence exists. EGS has a long tradition to provide guidance to the ophthalmic community in Europe and worldwide through the EGS Guidelines (now in their 5th Edition). The EGS leadership recognized that the changing environment in glaucoma surgery currently represents a major challenge for the clinician, needing specific guidance. Therefore, the decision was made to issue this Guide on Glaucoma Surgery in order to help clinicians to make appropriate decisions for their patients and also to provide the framework and guidance for researchers to improve the quality of evidence in future studies. Ultimately this Guide will support better Glaucoma Care in accordance with EGS's Vision and Mission. Fotis Topouzis EGS President

Efficacy and safety of deep sclerectomy with uveoscleral implant plus collagen matrix implant overcoming the superficial scleral flap in glaucoma surgery.

AIM: To assess the efficacy and safety of non-penetrating deep sclerectomy (NPDS) with uveoscleral implant plus subconjunctival and intrascleral collagen matrix overcoming the superficial scleral flap lips (modified deep sclerectomy technique, DS) and minimal use of mitomycin C in glaucoma surgery. METHODS: A retrospective review of 47 consecutive glaucoma patients who underwent NPDS with DS between January 2017 and May 2018. Best-corrected visual acuity, intraocular pressure (IOP), post-operative need for glaucoma medications, visual field mean deviation (MD), re-interventions, needling revisions and laser goniopuncture were noted. Absolute success was defined as IOP≤18 mm Hg without topical medication. Relative success was defined as the same criteria but with the addition of any antihypertensive medication. IOP over 18 mm Hg on two consecutive follow-up visits was considered as a failure. RESULTS: Fifty-two eyes of 47 patients were evaluated. Mean preoperative IOP was 25.37±6.47 mm Hg, and decreased to 15.04±4.73 at 12mo and 12.21±4.1 at 24mo (all P<0.0001). Requirement for topical medications dropped from a mean of 3.06±0.25 per patient to 0.51±0.99 and 1.11±1.23 respectively after 12 and 24mo (all P<0.0001). No medications were required in 45.5% of patients after 24mo. Relative and absolute success rate at 24mo were 85.5%±5% and 48.5%±7.4%, respectively. CONCLUSION: DS is a safe and effective non-penetrating glaucoma surgery variation. It aims to retain the patency of all pathways created for aqueous humor drainage: the intrascleral bleb, the supraciliary space and the open communication between intrascleral and subconjunctival compartments.

The Association between Vascular Abnormalities and Glaucoma-What Comes First?

Glaucoma is a leading cause of irreversible blindness worldwide. While intraocular pressure (IOP) presents a major risk factor, the underlying pathophysiology still remains largely unclear. The correlation between vascular abnormalities and glaucoma has been deliberated for decades. Evidence for a role played by vascular factors in the pathogenesis of glaucomatous neurodegeneration has already been postulated. In addition, the fact that glaucoma causes both structural and functional changes to retinal blood vessels has been described. This review aims to investigate the published evidence concerning the relationship between vascular abnormalities and glaucoma, and to provide an overview of the "chicken or egg" dilemma in glaucoma. In this study, several biomarkers of glaucoma progression from a vascular perspective, including endothelin-1 (ET-1), nitric oxide, vascular endothelial growth factor (VEGF), and matrix metalloproteinases (MMPs), were identified and subsequently assessed for their potential as pharmacological intervention targets.

Influence of a Prostaglandin F2α Analogue on Corneal Hysteresis and Expression of Extracellular Matrix Metalloproteinases 3 and 9.

Purpose: Low corneal hysteresis (CH) is associated with an increased risk of glaucoma. Prostaglandin analogue (PGA) eye drops may exert their intraocular pressure (IOP)-lowering effect partially by increasing CH. Methods: Twelve pairs of organ-cultured human donor corneas were used in an ex vivo model. In each case, one cornea was treated with PGA (Travoprost) for 30 days, whereas the other served as an untreated control. IOP levels were simulated in an artificial anterior chamber model. CH was measured using the Ocular Response Analyzer (ORA). Corneal expression of matrix-metalloproteinases (MMPs) was assessed by immunhistochemistry and real-time polymerase chain reaction (RT-PCR). Results: Increased CH was observed in the PGA-treated corneas. However, at IOP between 10 and 20 mm Hg, CH was increased in PGA-treated corneas (13.12 ± 0.63 mm Hg; control: 12.34 ± 0.49 mm Hg), although not significantly (P = 0.14). CH was significantly increased at higher IOP levels (21-40 mm Hg; PGA-treated: 17.62 ± 0.40 mm Hg; control: 11.60 ± 0.39, P < 0.0001). Treatment with PGA resulted in increased expression of MMP-3 and MMP-9. Conclusions: CH was increased after exposure to PGA. However, this increase was significant only in eyes with higher IOP (>21 mm Hg). A significant increase in MMP-3 and -9 was observed in PGA-treated corneas, indicating structural changes in corneal biomechanics caused by PGA. Translational Relevance: PGAs alter biomechanical structures by directly upregulating MMP-3 and -9, and the increase in CH is dependent on the level of IOP. Therefore, PGAs may have a greater effect when baseline IOP is higher.

Clinical outcomes of the PAUL® glaucoma implant: One-year results.

BACKGROUND: To report one-year outcomes from a single-centre cohort undergoing PAUL® Glaucoma Implant (PGI) surgery. METHODS: Retrospective review of patients undergoing PGI surgery at the University Eye Hospital Bonn, Germany, from April 2021 to September 2021. RESULTS: Forty-five eyes of 41 patients were included. Qualified and complete success rates (95% CI) were 95.6% (88.9%-100%) and 73.3% (60%-86.7%) for Criterion A (IOP ≤ 21 mmHg), 84.4% (73.3%-93.3%) and 74.4% (51.1%-80.0%) for Criterion B (IOP ≤ 18 mmHg), 62.2% (48.9%-75.6%) and 46.7% (31.2%-62.2%) for Criterion C (IOP ≤ 15 mmHg) and 26.7% (13.3%-40.0%) and 22.2% (11.1%-33.3%) for Criterion D (IOP ≤ 12 mmHg), respectively. Mean IOP decreased from 26.1 mmHg (7-48 mmHg) to 12.0 mmHg (3-24 mmHg) (reduction of 48.83%) after 12 months with a reduction of IOP-lowering agents from 0.5 (0-3). One eye (2.2%) needed an injection of viscoelastic due to significant hypotony with AC shallowing, and four eyes (8.9%) developed choroidal detachments due to hypotony which resolved without further interventions after 6 weeks. Three patients (6.7%) developed tube exposure which required conjunctival revision with an additional pericardial patch graft. An intraluminal prolene stent was removed in 19 eyes (42.2%) after a mean time period of 8.4 months (2-12 m). Mean IOP before the removal was 21.9 mmHg (12-38 mmHg) and decreased to 11.3 mmHg (6-16 mmHg). CONCLUSIONS: PGI surgery is an effective procedure for reducing IOP and pressure-lowering therapy. An intraluminal prolene stent impedes hypotony in the early postoperative phase and enables further IOP lowering without additional interventions during the postoperative course.

[Comparison of glaucoma drainage implants]. / Glaukomdrainageimplantate im Vergleich.

Glaucoma drainage devices (tubes, GDI or GDD) are nowadays an important surgical option in the treatment of refractory glaucoma. They are frequently used in cases where previous glaucoma surgery has failed or in patients with a history of conjunctival scarring where other procedures are contraindicated or simply not possible. This article looks at the evolution of glaucoma drainage implants from the very beginning to the multiple designs, experiences and research studies that have made tubes an essential part of the armamentarium of modern glaucoma surgeons. The article describes the first concepts and then proceeds to the first commercialized devices which led to the widespread use of tubes such as Molteno®, Baerveldt® and Ahmed®. Finally, it looks at the innovations that have been carried out, particularly over the last decade with the advent of new tubes, such as Paul®, eyeWatch® and Ahmed ClearPath®. The factors associated with the success and failure of GDD surgery, including the indications, are different from those for trabeculectomy and increasing experience and larger amounts of data have helped glaucoma surgeons to become more comfortable with selecting the most appropriate procedure for the individual patients.

Five-Year Clinical Outcomes of Inferior Quadrant Trabectome Surgery for Open Angle Glaucoma.

PRCIS: This retrospective study of 264 eyes having inferior quadrant trabectome surgery confirms its safety and relative effectiveness. Most patients however still require IOP-lowering agents, and a considerable proportion may need additional glaucoma surgery. PURPOSE: To report outcomes from a large single-center cohort of inferiorly-applied trabectome surgery. PATIENTS AND METHODS: Retrospective review of patients undergoing trabectome surgery for chronic open angle glaucoma (COAG) at the University Eye Clinic Bonn, Germany, from 2012 to 2020. RESULTS: Two hundred sixty-four eyes of 206 patients with COAG were included. The mean review period was 45.43 (range 12-101) months. One hundred five eyes (39.8%) underwent standalone surgery, of which 74 were pseudophakic and 31 phakic. The mean preoperative IOP was 17.58 mm Hg (range 12-50 mm Hg). One hundred five eyes (39.8%) developed a 'failure event' according to pre-defined criteria at a mean interval of 14.8 months postoperative. In absolute terms, 211 patients (79.9%) had a long-term IOP >14 mm Hg at 7.6 months, 174 patients (65.9%) >16 mm Hg at 10.6 months, 127 patients (48.1%) >18 mm Hg at 10.9 months, and 77 patients (29.2%) >21 mm Hg at 11.1 months. Over a five-year period, overall mean IOP remained stable at 13 mm Hg. The majority of patients were still on glaucoma drops (the mean number reduced from 2.9 to 2.7 agents). Subgroup analyses showed that a higher preoperative IOP was a positive predictor for failure, whereas combined surgery (with phaco) had better IOP outcomes (16.5 mm Hg vs. 19.3 mm Hg, respectively). Forty-one patients (15.5%) developed minor complications: 22 had high postoperative IOP within 3 months, 11 developed a self-resorbing hyphema, and 6 had fibrinous uveitis. CONCLUSIONS: Trabectome surgery is a safe and relatively effective procedure for lowering IOP, but most patients still need IOP-lowering agents, and a considerable proportion may need additional glaucoma surgery within a relatively short time. Inferior quadrant treatment may result in inferior IOP outcomes when compared with nasal quadrant surgery.

Advances in Glaucoma Surgery.

Glaucoma is one of the leading causes of irreversible sight loss worldwide, with a prevalence of 64 [...].

Clinical Outcomes of XEN45®-Stent Implantation after Failed Trabeculectomy: A Retrospective Single-Center Study.

BACKGROUND: The implantation of a collagen gel micro-stent (XEN45®) as a minimally invasive form of glaucoma surgery (MIGS) after a failed trabeculectomy (TE) may be an effective option with few risks. This study investigated the clinical outcome of XEN45® implantation after a failed TE, with follow-up data of up to 30 months. MATERIALS AND METHODS: In this paper, we present a retrospective review of patients undergoing XEN45® implantation after a failed TE at the University Eye Hospital Bonn, Germany, from 2012 to 2020. RESULTS: In total, 14 eyes from 14 patients were included. The mean follow-up time was 20.4 months. The mean time duration between the failed TE and XEN45® implantation was 110 months. The mean intraocular pressure (IOP) decreased from 17.93 mmHg to 12.08 mmHg after one year. This value increased again to 17.63 mmHg at 24 months and 16.00 mmHg at 30 months. The number of glaucoma medications decreased from 3.2 to 0.71, 2.0, and 2.71 at 12, 24, and 30 months, respectively. CONCLUSIONS: XEN45® stent implantation after a failed TE did not lead to an effective long-term decrease in IOP and glaucoma medications in many patients in our cohort. Nevertheless, there were cases without the development of a failure event and complications, and others in whom further, more invasive surgery was delayed. XEN45® implantation in some failed trabeculectomy cases may, therefore, be a good option, especially in older patients with multiple comorbidities.

Short-term safety and efficacy of Preserflo™ Microshunt in glaucoma patients: a multicentre retrospective cohort study.

BACKGROUND/AIMS: To evaluate 1-year success rates and safety profile of Preserflo™ Microshunt in glaucoma patients. METHODS: Retrospective multicentre cohort study of 100 consecutive eyes (91 patients) from four tertiary-referral glaucoma centres. Four intraocular pressure (IOP) criteria were defined: A: IOP ≤ 21 mmHg+IOP reduction ≥20% from baseline; B: IOP ≤ 18 mmHg+IOP reduction ≥20%; C: IOP ≤ 15 mmHg+IOP reduction ≥25%; D: IOP≤12 mmHg+IOP reduction ≥30%. Success was defined as qualified or complete based on whether reached with or without medication. Primary outcome was success according to the above criteria. Secondary outcomes included: IOP, best-corrected visual acuity (BCVA), medication use, complications, postoperative interventions, and failure-associated factors. RESULTS: Qualified and complete success rates (95% CI) at 12 months were 74%(66-83%) and 58%(49-69%) for criterion A, 72%(63-82%) and 57%(48-68%) for B, 52%(43-63%) and 47%(38-58%) for C, 29%(21-40%) and 26%(19-36%) for D. Overall median (interquartile range (IQR)) preoperative IOP decreased from 21.5(19-28) mmHg to 13(11-16) mmHg at 12 months. BCVA was not significantly different up to 12 months (p = 0.79). Preoperative median (IQR) number of medications decreased from 3 (2-3) to 0 (0-1) at 12 months. Twelve eyes underwent needling, five surgical revision and one device removal due to corneal oedema. There were no hypotony-related complications. Non-Caucasian ethnicity was the only risk factor consistently associated with increased failure. CONCLUSIONS: Preserflo™ Microshunt is a viable surgical option in glaucoma patients, with reasonable short-term success rates, decreased medications use, excellent safety profile, smooth postoperative care, and rapid learning curve. Success rates for the most stringent IOP cutoffs were modest, indicating that it may not be the optimal surgery when very low target IOP is required.