Understanding Acanthamoeba Keratitis: An In-Depth Review of a Sight-Threatening Eye Infection.

Acanthamoeba keratitis (AK) is a rare but potentially sight-threatening corneal infection caused by the Acanthamoeba parasite. This microorganism is found ubiquitously in the environment, often in freshwater, soil, and other sources of moisture. Despite its low incidence, AK presents significant challenges due to delayed diagnosis and the complex nature of therapeutic management. Early recognition is crucial to prevent severe ocular complications, including corneal ulceration and vision loss. Diagnostic modalities and treatment strategies may vary greatly depending on the clinical manifestation and the available tools. With the growing reported cases of Acanthamoeba keratitis, it is essential for the ophthalmic community to thoroughly understand this condition for its effective management and improved outcomes. This review provides a comprehensive overview of AK, encompassing its epidemiology, risk factors, pathophysiology, clinical manifestations, diagnosis, and treatment.

Effectiveness and safety of XEN45 implant over 12 months of follow-up: data from the XEN-Glaucoma Treatment Registry.

OBJECTIVES: To evaluate the 1-year effectiveness and safety of the XEN45, either alone or in combination with phacoemulsification, in glaucoma patients. METHODS: This multicentre, prospective, observational study included consecutive eyes of glaucoma patients from the Italian XEN-Glaucoma Treatment Registry (XEN-GTR) who underwent XEN45 alone or in combination with phacoemulsification, with at least 1 year of follow-up. Surgical success was defined as intraocular pressure (IOP) < 18 mmHg and ≥20% reduction from preoperative IOP, over 1 year of follow-up. RESULTS: Two hundred thirty-nine eyes (239 patients) were analyzed, 144 (60.2%) eyes in the XEN-solo and 95 (39.8%) eyes in the XEN+Phaco groups. One hundred-sixty-eight (70.3%) eyes achieved overall success, without statistically significant differences between study groups (p = 0.07). Preoperative IOP dropped from a median (IQR) of 23.0 (20.0-26.0) mmHg to 14.0 (12.0-16.0) mmHg at month 12 (p < 0.001), with overall 39.9 ± 18.3% IOP reduction. The mean number of preoperative ocular hypotensive medications (OHM) was significantly reduced from 2.7 ± 0.9 to 0.5 ± 0.9 at month 12 (p < 0.001). Preoperative IOP < 15 mmHg (HR: 6.63; 95%CI: 2.61-16.84, p < 0.001) and temporal position of the surgeon (HR: 4.25; 95%CI: 2.62-6.88, p < 0.001) were significantly associated with surgery failure. One hundred-forty-six (61.1%) eyes had no intraoperative complications, whereas 91 (38.1%) and 56 (23.4%) eyes experienced at least one complication, respectively early (< month 1) and late (≥ month 1), all self-limiting or successfully treated without sequelae. Needling occurred in 55 (23.0%) eyes at least once during follow-up. CONCLUSION: Over 1-year follow-up, XEN45 alone or in combination with phacoemulsification, had comparable success rates and effectively and safely lowered IOP and the need for OHM.

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.

Two-Year Performance and Safety Results of the MINIject Supraciliary Implant in Patients With Primary Open-Angle Glaucoma: Meta-Analysis of the STAR-I, II, III Trials.

PURPOSE: To evaluate the performance and safety of minimally invasive glaucoma surgery with a supraciliary drainage device (MINIject; iSTAR Medical, Wavre, Belgium) in primary open-angle glaucoma (POAG) as a stand-alone procedure. DESIGN: Meta-analysis. METHODS: At 11 sites in Colombia, France, Germany, India, Panama, and Spain, 82 patients were treated in 3 prospective, multicenter, interventional, nonrandomized trials (STAR-I, II, III). Data were pooled in a meta-analysis of up to 2 years of follow-up postimplantation. The main outcome measures were mean relative and absolute reduction in diurnal intraocular pressure (IOP) compared to baseline. Secondary outcomes included patients with IOP ≤18 mmHg, patients with IOP reduction ≥20%, number of IOP-lowering medications, adverse events, and endothelial cell density loss. RESULTS: At the 2-year follow-up (n = 66), mean IOP was reduced from 23.8 ± 3.3 mmHg at baseline to 14.4 ± 4.5 mmHg (-39.3%; P < 0.0001). An IOP reduction of ≥20% was achieved in 89.4% of patients, with 84.8% having an IOP ≤18 mmHg. IOP-lowering medications were reduced from a mean of 2.4 ± 1.1 to 1.4 ± 1.4 (P < 0.0001), with 37.9% of patients being medication-free at 2 years. Mean endothelial cell density loss at 2 years was 6.2 ± 9.1% compared to baseline and no patient had a loss >30%. CONCLUSIONS: This meta-analysis demonstrates the favorable safety and efficacy profile of a supraciliary device implanted in a stand-alone, ab-interno procedure in patients with mild-to-moderate POAG. The data demonstrate that MINIject is a safe and effective, bleb-free treatment option for patients requiring low target IOP up to 2 years.

Hydrus microstent for the treatment of primary open-angle glaucoma: overview of its safety and efficacy.

INTRODUCTION: Minimally invasive glaucoma surgeries (MIGS) are now a consolidated reality in many surgical units. The Hydrus Microstent is one of several MIGS devices bypassing trabecular outflow and had excellent results over the years. This article aims to review the key features of the Hydrus Microstent in terms of design, efficacy, and safety. AREAS COVERED: The present review analyses the main characteristics of the device by evaluating the technical and physical details of its functioning. The evidence that supports a clinical decision summarizes the most influential clinical trials and the most accurate systematic reviews. EXPERT OPINION: The Hydrus device has been extensively studied regarding biocompatibility and outflow potential. The subsequent clinical studies have been well-built and proved that the device effectively reduces intraocular pressure (IOP) and the eyedrop load. The device covers almost a quarter of Schlemm's canal circumference, offering at least two advantages: cannulating the Schlemm's canal provides evidence that the device has been implanted correctly; covering a larger area potentially allows to target multiple collector channels or at least areas of active outflow. This scaffold may prove more effective in naïve patients or subjects who used antiglaucoma eyedrops for a limited period, as the prolonged use of hypotonic medications has been associated with the surgical failure of ab interno microhook trabeculotomy.

Effectiveness and Safety of Xen Gel Stent in Glaucoma Surgery: A Systematic Review of the Literature.

Although topical medical therapy and selective-laser-trabeculoplasty represent the treatments of choice to reduce intraocular pressure, many patients do not achieve adequate glaucoma control; therefore, they require further options and eventually surgery. Trabeculectomy is still considered the gold standard, but the surgical management of glaucoma has undergone continuous advances in recent years, XEN-gel-stent has been introduced as a safer and less traumatic means of lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG). This study aimed to review the effectiveness and safety of clinical data on XEN-stent in OAG patients with a Synthesis-Without-Meta-analysis (SWiM) methodology. A total of 339 studies were identified following a literature search adhering to PRISMA guidelines and, after evaluation, 96 studies are discussed. XEN63 and XEN45 device data were collected both short and long term. In addition, this document has evaluated different aspects related to the XEN implant, including: its role compared to trabeculectomy; the impact of mitomycin-C dose on clinical outcomes; postoperative management of the device; and the identification of potential factors that might predict its clinical outcomes. Finally, current challenges and future perspectives of XEN stent, such as its use in fragile or high myopia patients, were discussed.

Candida Biofilm Eye Infection: Main Aspects and Advance in Novel Agents as Potential Source of Treatment.

Fungi represent a very important cause of microbial eye infections, especially in tropical and developing countries, as they could cause sight-threating disease, such as keratitis and ocular candidiasis, resulting in irreversible vision loss. Candida species are among the most frequent microorganisms associated with fungal infection. Although Candida albicans is still the most frequently detected organism among Candida subspecies, an important increase in non-albicans species has been reported. Mycotic infections often represent an important diagnostic-clinical problem due to the difficulties in performing the diagnosis and a therapeutic problem due to the limited availability of commercial drugs and the difficult penetration of antifungals into ocular tissues. The ability to form biofilms is another feature that makes Candida a dangerous pathogen. In this review, a summary of the state-of-the-art panorama about candida ocular pathology, diagnosis, and treatment has been conducted. Moreover, we also focused on new prospective natural compounds, including nanoparticles, micelles, and nanocarriers, as promising drug delivery systems to better cure ocular fungal and biofilm-related infections. The effect of the drug combination has also been examined from the perspective of increasing efficacy and improving the course of infections caused by Candida which are difficult to fight.

Pharmacological Approaches to Modulate the Scarring Process after Glaucoma Surgery.

Glaucoma is an acquired optic neuropathy that results in a characteristic optic nerve head appearance and visual field loss. Reducing the IOP is the only factor that can be modified, and the progression of the disease can be managed through medication, laser treatment, or surgery. Filtering procedures are used when target pressure cannot be obtained with less invasive methods. Nevertheless, these procedures require accurate control of the fibrotic process, which can hamper filtration, thus, negatively affecting the surgical success. This review explores the available and potential pharmacological treatments that modulate the scarring process after glaucoma surgery, analyzing the most critical evidence available in the literature. The modulation of scarring is based on non-steroidal anti-inflammatory drugs (NSAIDs), mitomycin, and 5-fluorouracil. In the long term, the failure rate of filtering surgery is mainly due to the limitations of the current strategies caused by the complexity of the fibrotic process and the pharmacological and toxicological aspects of the drugs that are currently in use. Considering these limitations, new potential treatments were investigated. This review suggests that a better approach to tackle the fibrotic process may be to hit multiple targets, thus increasing the inhibitory potential against excessive scarring following surgery.

Safety and Efficacy of Ab Interno XEN 45 Gel Stent in Patients with Glaucoma and High Myopia.

This study reports on the safety and efficacy of Xen 45 in patients with glaucoma and high myopia. It was a retrospective study including patients with high myopia (>6D) who underwent Xen implant with 2 years of follow-up. The primary outcome was to report the incidence of hypotony (IOP ≤ 5 mmHg) and hypotony-related complications. Patients with high myopia treated with mitomycin-C-augmented trabeculectomy were included as a control group. We included 14 consecutive patients who underwent Xen implant (seven eyes) and trabeculectomy (seven eyes). The mean myopia was -14.71 ± 5.36 and -15.07 ± 6.11 in the trabeculectomy and Xen groups, respectively (p > 0.05). The success rate and the mean IOP at 1 and 2 years from the intervention were statistically comparable between the two groups. The group undergoing trabeculectomy showed a higher incidence of hypotony (six eyes (85.71%) vs. two eyes (28.57%)) and hypotony maculopathy (three eyes (42.86%) vs. zero eyes (0%)) and required more postoperative procedures. Patients with high myopia were at higher risk of hypotony-related complications after trabeculectomy. The Xen implant can achieve an IOP control comparable to trabeculectomy with a significantly better safety profile and can be considered as an option for the management of patients with high myopia and glaucoma.

Effectiveness and Safety of XEN45 in Eyes With High Myopia and Open Angle Glaucoma.

PRCIS: XEN45 implant was an effective and safe procedure in primary open angle glaucoma (OAG) eyes with high myopia. Although the hypotony incidence rate was relatively high, it resolved with medical therapy and was of short duration. PURPOSE: The purpose of this study is to evaluate the effectiveness and safety of the XEN45 stent in eyes with OAG and high myopia. DESIGN: Retrospective and multicenter study. METHODS: Consecutive OAG patients who underwent a XEN45, either alone or in combination with cataract surgery, and had a refractive error higher than -6 D and an axial length ≥26 mm. The primary endpoint was the mean intraocular pressure (IOP) lowering at the last follow-up visit. RESULTS: Thirty-one eyes were included (96.8% with a primary OAG diagnosis). The mean refraction was -13.2±5.6 (range: -6.75 to-23.0) D. In the overall study sample, preoperative mean IOP (95% CI) was significantly lowered from 23.5 (20.5-26.4) mm Hg to 13.0 (12.2-13.8) mm Hg at the last follow-up visit, P <0.0001. At the last follow-up visit, 16 (57.1%) eyes achieved an IOP ≤14 mm Hg, 11 (68.9%) of them without treatment. The number of ocular hypotensive medications was significantly reduced from 3.0±1.1 drugs at preoperatively to 0.6±1.0 drugs at the last follow-up visit, P <0.0001. Median (95% CI) follow-up was 24.0 (12.0-24.0) months. Linear regression analysis showed a significant correlation between the preoperative refraction and the IOP lowering ( r =0.43, P =0.0155). Needling procedure was performed in 11 eyes (39.3%) and hypotony (defined as an IOP <6 mm Hg) was observed in 8 eyes (28.6%) during the first postoperative day and remained for a week. CONCLUSION: Although the Xen implant effectively lowered IOP in highly myopic eyes with glaucoma, the incidence of hypotony was high, and in most cases, resolved within the first month with medical management and monitoring.

Precision Medicine in Glaucoma: Artificial Intelligence, Biomarkers, Genetics and Redox State.

Glaucoma is a multifactorial neurodegenerative illness requiring early diagnosis and strict monitoring of the disease progression. Current exams for diagnosis and prognosis are based on clinical examination, intraocular pressure (IOP) measurements, visual field tests, and optical coherence tomography (OCT). In this scenario, there is a critical unmet demand for glaucoma-related biomarkers to enhance clinical testing for early diagnosis and tracking of the disease's development. The introduction of validated biomarkers would allow for prompt intervention in the clinic to help with prognosis prediction and treatment response monitoring. This review aims to report the latest acquisitions on biomarkers in glaucoma, from imaging analysis to genetics and metabolic markers.

The current use of glaucoma virtual clinics in Europe.

OBJECTIVES: To assess and describe current utilisation, characteristics and perspectives on virtual glaucoma clinics (VGCs) amongst European glaucoma specialists. METHODS: Cross-sectional, anonymized, online questionnaire distributed to all European Glaucoma Society-registered specialists. Questions were stratified into five domains: Demographics, Questions about VGC use, Questions for non-VGC users, COVID-19 effects, and VGC advantages/disadvantages. RESULTS: 30% of 169 participants currently use VGCs, with 53% based in the United Kingdom. Of those using VGCs, 85% reported higher patient acceptance compared to traditional care. The commonest virtual model was asynchronous remote monitoring (54%). Nurses (49%) and ophthalmic technicians (46%) were mostly responsible for data collection, with two-thirds using a mixture of professionals. Consultant ophthalmologists were the main decision-makers in 51% of VGCs. Preferred cohorts were: ocular hypertension (85%), glaucoma suspects (80%), early/moderate glaucoma in worse eye (68%), stable glaucoma irrespective of treatment (59%) and stable glaucoma on monotherapy (51%). Commonest investigations were: IOP (90%), BCVA (88%), visual field testing (85%) and OCT (78%), with 33 different combinations. Reasons for face-to-face referral included: visual field progression (80%), 'above-target' IOP (63%), and OCT progression (51%). Reasons for not using VGCs included: lack of experience (47%), adequate systems in place (42%), no appropriate staff (34%) and insufficient time/money (34%). 55% of non-VGC users are interested in their use with 38% currently considering future implementation. 83% stated VGC consultations have increased during the COVID-19 pandemic; 86% of all participants felt that the pandemic has highlighted the importance of VGCs. CONCLUSIONS: A significant proportion of European glaucoma units are currently using VGCs, while others are considering implementation. Financial reimbursement and consensus guidelines are potentially crucial steps in VGC uptake.

Italian Candidates for the XEN Implant: An Overview from the Glaucoma Treatment Registry (XEN-GTR).

Background The Italian XEN Glaucoma Treatment Registry (XEN-GTR) was created to acquire a comprehensive prospective dataset that includes the patient characteristics, intraoperative variables, and postoperative management of glaucoma patients undergoing the XEN gel stent implantation. Methods This was a prospective observational, longitudinal clinical study involving 10 centres throughout Italy. The baseline examination included a comprehensive evaluation of demographic parameters (age, sex, ethnicity, and systemic condition), specific ophthalmological parameters, and quality of life questionnaire score collection. Results The baseline data of 273 patients were analysed. The median (IQR) age was 72 (65.0 to 78.0) years. Of the 273 patients, 123 (45%) were female and 150 (55%) were male. A total of 86% of the patients had open-angle glaucoma with a mean intraocular pressure of 24 ± 6 (range 12.0-60.0) mmHg. The mean number of medications was 2.7 ± 0.9 at baseline for the patients with a prevalence of prostaglandin analogues combined with a beta-blocker and anhydrase carbonic inhibitor (31.8%). The mean scores of the NEI-VFQ 25 and GSS questionnaires were 78 ± 18 (range 26.5-100) and 85 ± 14 (range 79-93), respectively. Combined XEN/cataract surgeries were scheduled in 73.7% of the patients. The preferred place for the XEN implant was the supero-nasal quadrant (91.6%). Conclusions Observing the baseline characteristics of the typical Italian candidates for the XEN gel implant shows that they are patients affected by POAG and cataracts, with moderate to severe glaucoma damage, all of which has an impact on their quality of life.

Glaucoma Treatment and Hydrogel: Current Insights and State of the Art.

Aqueous gels formulated using hydrophilic polymers (hydrogels) and those based on stimuli-responsive polymers (in situ gelling or gel-forming systems) attract increasing interest in the treatment of several eye diseases. Their chemical structure enables them to incorporate various ophthalmic medications, achieving their optimal therapeutic doses and providing more clinically relevant time courses (weeks or months as opposed to hours and days), which will inevitably reduce dose frequency, thereby improving patient compliance and clinical outcomes. Due to its chronic course, the treatment of glaucoma may benefit from applying gel technologies as drug-delivering systems and as antifibrotic treatment during and after surgery. Therefore, our purpose is to review current applications of ophthalmic gelling systems with particular emphasis on glaucoma.

Outcomes of XEN 63 Device at 18-Month Follow-Up in Glaucoma Patients: A Two-Center Retrospective Study.

Background: Glaucoma surgery has significantly evolved over the last years. This paper aims to evaluate the midterm clinical outcomes of the XEN63 device in a real-world scenario. Methods: A retrospective clinical study was conducted on consecutive patients who underwent an XEN63 implant insertion, either alone or in combination with phacoemulsification. The primary endpoint was the mean intraocular pressure (IOP) at the month 18 visit. Results: Twenty-three eyes (23 patients) were included in the analysis. The preoperative IOP was significantly lowered from 27.0 ± 7.8 mmHg to 14.1 ± 3.4 mmHg at month 18 (p < 0.0001). At month 18, 14 (77.8%) and 11 (61.1%) eyes had an IOP ≤ 16 mmHg and ≤ 14 mmHg, respectively, without ocular hypotensive medication. The mean number of ocular hypotensive medication taken was significantly reduced from 2.3 ± 0.9 drugs at baseline to 1.0 ± 1.4 drugs at month 18 (p = 0.0020). Four (17.4%) eyes had hypotony at postoperative day 1, which was successfully resolved without sequelae. Four (17.4%) eyes underwent a needling procedure and four (17.4%) eyes underwent additional surgeries. Conclusions: The XEN63, either alone or in combination with cataract surgery, significantly lowered the IOP and reduced the need for ocular hypotensive drugs over a period of 18 months.

A New and Easier Approach to Preserflo MicroShunt Implantation.

PRESERFLO™ MicroShunt is a new minimally invasive glaucoma surgical (MIGS) device, implanted with an ab externo approach, which drains the aqueous humor to the subconjunctival space. It has been designed as a safer and less invasive approach for treating medically uncontrolled primary open-angle glaucoma (POAG) patients. The classic way of MicroShunt implantation involves different key steps, which includes creating a small scleral pocket with a 1mm blade; passing a 25-gauge (25G) needle through the scleral pocket into the anterior chamber (AC); and subsequently flushing the stent with a 23-gauge (23G) thin-wall cannula. However, sliding the needle into the scleral pocket can create false passages, thus making the device's threading more difficult. The purpose of the current paper is to propose a simplified implantation approach. Our method proposes to make the scleral tunnel by using directly the 25G needle and, at the limbus, this 25G needle is used to slightly depress the sclera and enter into the AC. The MicroShunt is subsequently assembled on a 23G cannula mounted on a 1mL syringe. The syringe can then be used to flush the device. Outflow can thus be confirmed immediately by seeing drops of aqueous humor leaking from the external opening of the stent. This new approach may have different potential advantages, such as better control of the site of entry, avoids wrong passages, reduces or eliminates the risk of aqueous humor sideway flow, facilitates a parallel path to the iris plane, and it is faster.

Effectiveness of MicroShunt in Patients with Primary Open-Angle and Pseudoexfoliative Glaucoma: A Retrospective European Multicenter Study.

PURPOSE: To evaluate the effectiveness and safety of the Preserflo MicroShunt implant (Santen) in patients with primary open-angle glaucoma (POAG) and pseudoexfoliation glaucoma (PXG). DESIGN: Retrospective, open-label, multicenter study. PARTICIPANTS: Patients with insufficiently controlled primary POAG or PXG who underwent a standalone MicroShunt implantation procedure. METHODS: Consecutive patients with POAG and PXG who underwent surgery with the ab externo minimally invasive glaucoma surgery device Preserflo MicroShunt with mitomycin C. MAIN OUTCOME MEASURES: Primary end points were mean change in intraocular pressure (IOP) and number of hypotensive medications from baseline through month 12. Success was defined as an IOP of 18 mmHg or less and an IOP reduction of 20% or more, with (qualified) or without (complete) any hypotensive medication. RESULTS: Among the 130 patients who underwent MicroShunt implantation, 104 fulfilled the inclusion and exclusion criteria and were included in the analysis. Eighty-one eyes (77.9%) were diagnosed with POAG and 23 eyes (22.1%) were diagnosed with PXG. The mean age was 71.4 ± 12.6 years, and 45 patients (43.3%) were women. Mean IOP was lowered significantly from 25.1 ± 6.5 mmHg at baseline to 14.1 ± 3.4 mmHg at month 12 (P < 0.0001). At month 12, 27 eyes (26.0%) were categorized as complete successes and 61 eyes (58.7%) were categorized as qualified successes. The mean number of hypotensive medications was reduced significantly from 3.0 ± 1.0 medications at the preoperative visit to 0.77 ± 0.95 medication at month 12 (P < 0.001). Throughout the study, 19 eyes (18.3%) required needling and 14 eyes (13.5%) underwent surgical revision. Eight eyes (7.7%) showed hyphema and 5 eyes (4.8%) showed choroidal detachment. These were resolved with medical therapy without sequelae. Four patients underwent subsequent surgeries, and 2 patients underwent trabeculectomy (at months 3 and 6): One patient underwent transscleral cyclophotocoagulation at month 3 and 1 patient underwent MicroPulse cyclophotocoagulation at month 4. CONCLUSIONS: In this retrospective study, the MicroShunt effectively lowered IOP and the need for IOP-lowering medications.

Cost-utility analysis of trabecular micro-bypass stents (TBS) in patients with mild-to-moderate open-angle Glaucoma in Italy.

BACKGROUND: Glaucoma is a disease characterized by progressive damage of the optic nerve. Several therapeutic options are available to lower intraocular pressure (IOP). In primary open-angle glaucoma (POAG) patients with inadequate IOP control (or controlled with multiple medical therapies or for whom medical therapy is contraindicated), the implantation of micro-invasive glaucoma surgery devices (MIGS) and concomitant cataract surgery has proved to be more effective in reducing intraocular pressure (IOP), as compared to cataract surgery alone. The objective of this study was to assess the cost-effectiveness of iStent inject® device with concurrent cataract surgery vs. cataract surgery alone, in patients with mild-to-moderate POAG, adopting the Italian National Health Service (NHS) perspective. METHODS: Simulation of outcomes and costs was undertaken using a Markov model with 4 health states and one-month cycles, that is used to simulate the prognosis of these patients. Efficacy data were obtained from the randomized clinical trial (RCT). A lifetime horizon was adopted in the analysis. A discount rate of 3.5% was applied to both costs and effects. The Italian National Healthcare Service (NHS) perspective was considered, therefore only healthcare direct costs (acquisition of main interventions and subsequent procedures; medications; monitoring and follow-up; adverse events). Model robustness was tested through sensitivity analyses. RESULTS: Results of the base-case analysis showed that the total lifetime costs were higher in the iStent inject® + concurrent cataract surgery, compared with the cataract surgery alone group (€8368.51 vs. €7134.71 respectively). iStent inject® + concurrent cataract surgery was cost-effective vs. cataract surgery alone, with an incremental cost-effectiveness ratio of €13,037.01 per quality-adjusted life year (QALY) gained. Both one-way deterministic and probabilistic sensitivity analyses confirmed robustness of base-case results. The cost-effectiveness accessibility curve (CEAC) showed that iStent inject® + cataract surgery would have a 98% probability of being cost-effective, compared to cataract surgery alone, when the willingness to pay (WTP) is equal to €50,000 per QALY gained. CONCLUSIONS: The results of the cost-utility analysis confirm that iStent inject® + cataract surgery is a cost-effective option for the treatment of patients affected by mild-to-moderate POAG, compared with cataract surgery alone, when evaluated from the Italian NHS perspective.

Early Experience with the New XEN63 Implant in Primary Open-Angle Glaucoma Patients: Clinical Outcomes.

The new XEN63 implant is a minimally invasive glaucoma surgery device with limited experience in real life. This retrospective study included open-angle glaucoma patients who underwent XEN63 implant, either alone or in combination with cataract surgery. Primary endpoints were the intraocular pressure (IOP) at month 3 and the incidence of serious adverse events. Twenty-three eyes of 23 patients were included. Mean age was 67.8 ± 15.3 years and 15 (65.2%) were women. Mean IOP was significantly lowered from 27.0 ± 7.8 mmHg at baseline to 12.2 ± 3.4 mmHg at month 3 (p < 0.0001). Mean IOP lowering was 40.8 ± 23.5%, with 14 (60.9%) and 16 (69.6%) eyes achieving an IOP lowering ≥30% and ≥20% without hypotensive medication, respectively. The number of hypotensive medications (NHM) was significantly reduced from 2.27 ± 0.94 drugs at baseline to 0.09 ± 0.42 drugs at month 3, p < 0.0001. Four (17.4%) eyes had hypotony (IOP ≤ 6 mmHg) at postoperative day one, which was successfully resolved without sequelae. Four (17.4%) eyes had choroidal detachment (3 at day 7 and 1 at day 15), which was successfully resolved with medical treatment, at the month 1 visit. Three (13.0%) eyes required needling (mean time for needling 35.6 ± 9.7 days). XEN63 significantly lowered IOP and reduced the NHM, with a good short-term safety profile.

Hypertensive choroidopathy in atypical hemolytic-uremic syndrome.

PURPOSE: We present the case of a 22-year-old woman, diagnosed as having atypical hemolytic uremic syndrome with a hypertensive crisis, who presented a bilateral serous retinal detachment. CASE DESCRIPTION: A 22-year-old woman, diagnosed as having atypical hemolytic uremic syndrome, was referred for blurred vision in both eyes, evolving over 7 days. Treatment including hemodialysis, plasma exchange, systemic steroids, antihypertensive medications and eculizumab was started 1 month prior to referral. At presentation, best-corrected visual acuity was 20/40 in the right eye and 20/25 in the left eye. Retinal examination revealed bilateral serous retinal detachment in the posterior pole and some small, flat, variably pigmented lesions. Optical coherence tomography confirmed marked serous retinal detachment in both eyes. Fluorescein and indocyanine green angiography was performed. Treatment for systemic hypertension was changed. Seven days later, dilated fundus examination and optical coherence tomography demonstrated a significant regression of the serous retinal detachment. Her visual acuity improves in both eyes at the last control, showing at fundus examination a complete resolution of the exudative detachment but a persistence of variable flat pigmented lesion. CONCLUSION: Although multiple organ systems are commonly affected in hemolytic uremic syndrome, ocular involvement has only been described in very few cases. Ocular manifestations in atypical hemolytic uremic syndrome include retinal, choroidal and vitreal hemorrhages, retina and/or ischemic signs. Bilateral serous retinal detachment may also be a sign of atypical hemolytic uremic syndrome or even the first manifestation of a hypertensive event.