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Objective: To evaluate efficacy and safety outcomes of the Xen 45 gel stent implant over 24 months of follow-up. Methods: A retrospective analysis of prospectively collected data from the Fight Glaucoma Blindness observational registry. Complete success (CS) was defined as intraocular pressure (IOP) reduction ≥20% from preoperative and an IOP ≤18 mm Hg and ≥6 mm Hg with no secondary procedure at 2 years and without IOP-lowering medications. Qualified success (QS) was defined similarly, allowing the use of IOP-lowering medications. Results: The Xen 45 gel stent implant was implanted in 646 eyes of 515 patients. Preoperative IOP was 21.4±7.6 (mean±SD) mm Hg on 2.7±1.3 IOP-lowering medication and mean deviation was -10.2±8.4 dB. After 24-month follow-up, IOP was 16.8±7.3 mm Hg (mean reduction of 21.7%) on 1.2±1.4 IOP-lowering medications. CS and QS rates at 24 months were 26% and 48%, respectively. CS and QS were higher in the Xen stand-alone group (33% and 52%, respectively) than in the Xen+cataract group (16% and 42%, respectively). Bleb needling was performed in 28.4% of cases, and 18% underwent a secondary procedure. Conclusions: The Xen 45 gel stent implant offers acceptable long-term efficacy for the treatment of open-angle glaucoma. However, there is a significant rate of reoperation and needling, and outcomes are less effective if combined with cataract surgery. [ABSTRACT FROM AUTHOR]

Background/Objectives: Glaucoma is the leading cause of irreversible blindness, with a significant proportion of cases remaining undiagnosed globally. The interpretation of optic disc and retinal nerve fibre layer images poses challenges for optometrists and ophthalmologists, often leading to misdiagnosis. AI has the potential to improve diagnosis. This study aims to validate an AI system (a convolutional neural network based on the Inception-v3 architecture) for detecting glaucomatous optic neuropathy (GON) using colour fundus photographs from a UK population and to compare its performance against Australian optometrists. Methods: A retrospective external validation study was conducted, comparing AI's performance with that of 11 AHPRA-registered optometrists in Australia on colour retinal photographs, evaluated against a reference (gold) standard established by a panel of glaucoma specialists. Statistical analyses were performed using sensitivity, specificity, and area under the receiver operating characteristic curve (AUROC). Results: For referable GON, the sensitivity of the AI (33.3% [95%CI: 32.4–34.3) was significantly lower than that of optometrists (65.1% [95%CI: 64.1–66.0]), p < 0.0001, although with significantly higher specificity (AI: 97.4% [95%CI: 97.0–97.7]; optometrists: 85.5% [95%CI: 84.8–86.2], p < 0.0001). The optometrists demonstrated significantly higher AUROC (0.753 [95%CI: 0.744–0.762]) compared to AI (0.654 [95%CI: 0.645–0.662], p < 0.0001). Conclusion: The AI system exhibited lower performance than optometrists in detecting referable glaucoma. Our findings suggest that while AI can serve as a screening tool, both AI and optometrists have suboptimal performance for the nuanced diagnosis of glaucoma using fundus photographs alone. Enhanced training with diverse populations for AI is essential for improving GON detection and addressing the significant challenge of undiagnosed cases. [ABSTRACT FROM AUTHOR]

Background: To determine the 12-month compliance with and retention of home monitoring (HM) with Melbourne Rapid Fields (MRFh) for patients with intermediate age-related macular degeneration (iAMD) and compare visual acuity (VA) and retinal sensitivity (RS) results to clinical measures. Methods: Participants were recruited to a 12-month HM study with weekly testing of vision with MRFh. Inclusion criteria were a diagnosis of iAMD, understand English instructions, VA ≥ 20/40, and access to an iPad. Supervised in-clinic testing of high contrast VA (HVA, ETDRS), low-luminance VA (LLVA, ETDRS with ND2 filter), and RS (Macular Integrity Assessment, MAIA, and MRF in-clinic, MRFc) was conducted every 6-months. Results: A total of 54 participants (67 ± 6.8 years) were enrolled. Compliance to weekly HM was 61% and study retention at 12-months was 50% of those with uptake (n = 46). No difference was observed between MRFc and MRFh across all RS and VA outcomes (p > 0.05). MRFh RS was higher than MAIA (29.1 vs. 27.1 dB, p < 0.001). MRFh HVA was not different from ETDRS (p = 0.08), but LLVA was 9 letters better (81.5 vs. 72.4 letters, p < 0.001). Conclusions: Over 12-months, MRFh yields a moderate level of compliance with (61%) and retention (50%) of weekly testing. Further studies are required to assess the ability of MRFh to detect early progression to nAMD. [ABSTRACT FROM AUTHOR]

Visual fields are an integral part of glaucoma diagnosis and management. COVID has heightened the awareness of the potential for viral spread with the practice of visual fields modified. Mask artefacts can occur due to fogging of the inferior rim of the trail lens. Fortunately, the risk of airborne transmission when field testing is low. The 24‐2c may be useful to detect early disease and the 10‐2 more sensitive to detect advanced loss. The SITA faster test algorithm is able to reduce testing time thereby improving clinic efficiency, however, may show milder results for moderate or severe glaucoma. The technician has an important role of supervising the visual field performance to achieve reliable output. Home monitoring can provide earlier detection of progression and thus improve monitoring of glaucoma as well as reduce the burden of in‐clinic assessments. Artificial Intelligence has been found to have high sensitivity and specificity compared to expert observers in detecting field abnormalities and progression as well as integrating structure with function. Although these advances will improve efficiency and guide accuracy, there will remain a need for clinicians to interpret the results and instigate management. [ABSTRACT FROM AUTHOR]

Background: Our primary aim is to quantify test reliability and compliance of glaucoma patients to a weekly visual field telemedicine (VFTM) schedule. A secondary aim is to determine concordance of the VFTM results to in-clinic outcomes. Methods: Participants with stable glaucoma in one eye were recruited for a 12 month VFTM trial using the Melbourne Rapid Fields (MRF-home, MRFh) iPad application. Participants attended routine 6 month clinical reviews and were tasked with weekly home monitoring with the MRFh over this period. We determined compliance to weekly VFTM (7 + 1 days) and test reliability (false positives (FPs) and fixation loss (FL) <33%). A secondary aim considered concordance to in-clinic measures of visual field (MRF-clinic (MRFc) and the Humphrey Field Analyzer (HFA)) in active participants (≥10 home examinations and 5 reliable HFA examinations). The linear trend in the MRFh mean deviation (MD) was compared to the HFA guided progression analysis (GPA) using Bland–Altman methods. Data are shown as the mean ± standard deviation. Results: Forty-seven participants with a mean age of 64 ± 14.6 years were recruited for the trial. The VFTM uptake was 85% and compliance to weekly home monitoring was 75% in the presence of weekly text reminders in the analysed group (n = 20). The analysed group was composed of test subjects with five reliable in-clinic HFA examinations (GPA analysis available) and who submitted a minimum of 10 MRFh examinations from home. Of the 757 home examinations returned, approximately two-thirds were reliable, which was significantly lower than the test reliability of the HFA in-clinic (MRFh: 65% vs. HFA: 85%, p < 0.001). The HFA-GPA analysis gave little bias from the MRFh slope (bias: 0.05 dB/yr, p > 0.05). Two eyes were found to have clinical progression during the 12 month period, and both were detected by VFTM. Conclusions: VFTM over 12 months returned good compliance (75%) to weekly testing with good concordance to in-clinic assays. VFTM is a viable option for monitoring patients with glaucoma for visual field progression in between clinical visits. [ABSTRACT FROM AUTHOR]

Background: Prolonged-release fampridine (PR-FAM) 10-mg tablet twice daily is the only approved pharmacological treatment for improvement of walking ability in adults with multiple sclerosis (MS). LIBERATE assessed the safety/effectiveness of PR-FAM in the real-world. Objectives: The aim of this study was to collect additional safety data, including the incidence rate of seizures and other adverse events (AEs) of interest, from patients with MS taking PR-FAM in routine clinical practice (including patients aged ≥ 65 years and those with pre-existing cardiovascular risk factors). Other objectives included change over time in patient-reported evaluation of physical and psychological impact of MS while taking PR-FAM, and change over time in physician-reported assessment of walking ability in MS patients taking PR-FAM. Methods: Patients with MS newly prescribed PR-FAM were recruited (201 sites, 13 countries). Demographic/safety data were collected at enrolment through 12 months. Physician-rated Clinical Global Impression of Improvement (CGI-I) scores for walking ability, and Multiple Sclerosis Impact Scale-29 (MSIS-29) were assessed. Results: Safety analysis included 4646 patients with 3534.8 patient-years of exposure; median (range) age, 52.6 (21–85) years, 87.3% < 65 years, and 65.7% women. Treatment-emergent AEs (TEAEs) were reported in 2448 (52.7%) patients, and serious TEAEs were reported in 279 (6.0%) patients, of whom 37 (< 1%) experienced treatment-emergent serious AEs (TESAEs) considered related to PR-FAM. AEs of special interest (AESI) occurred in 1799 (38.7%) patients, and serious AESI in 128 (2.8%) patients. Seventeen (< 1%) patients experienced actual events of seizure. Overall, 1158 (24.9%) patients discontinued treatment due to lack of efficacy. At 12 months, a greater proportion of patients on-treatment had improvement from baseline in CGI-I for walking ability versus those who discontinued (61% vs. 11%; p < 0.001). MSIS-29 physical impact score improved significantly for patients on-treatment for 12 months versus those who discontinued (mean change, baseline to 12 months: − 9.99 vs. − 0.34 points; p < 0.001). Results were similar for MSIS-29 psychological impact. Conclusion: No new safety concerns were identified in this real-world study, suggesting that routine risk-minimization measures are effective. CGI-I and MSIS-29 scores after 12 months treatment with PR-FAM treatment show clinical benefits consistent with those previously reported. Trial Registration: ClinicalTrials.gov: NCT01480063. [ABSTRACT FROM AUTHOR]

This article responds to a letter proposing a checklist approach for clinicians to determine whether an artificial intelligence (AI) algorithm is ready for use in medical practice. The checklist is designed to help clinicians evaluate the potential benefits and limitations of proposed algorithms, including their effectiveness, transparency, and generalizability. The article suggests that ethical implications, regulatory oversight, cybersecurity, data ownership, patient autonomy, and informed consent should also be considered when using AI in medical practice. The authors conclude that while AI algorithms for visual field analysis are still in their infancy, clinicians should carefully evaluate the evidence and potential risks and benefits before implementing them in their practice. [Extracted from the article]

Background: In the assessment of a pituitary mass, objective visual field testing represents a valuable means of evaluating mass effect, and thus in deciding whether surgical management is warranted.Case Presentation: In this vignette, we describe a 73 year-old lady who presented with a three-week history of frontal headache, and 'blurriness' in the left side of her vision, due to a WHO grade III anaplastic haemangiopericytoma compressing the optic chiasm. We report how timely investigations, including an iPad-based visual field test (Melbourne Rapid Field, (MRF)) conducted at the bedside aided swift and appropriate management of the patient.Conclusions: We envisage such a test having a role in assessing bed-bound patients in hospital where access to formal visual field testing is difficult, or indeed in rapid testing of visual fields at the bedside to screen for post-operative complications, such as haematoma. [ABSTRACT FROM AUTHOR]

Background. Patient race and ethnicity have historically impacted HCV treatment response. This phase 3 study evaluated daclatasvir with peginterferon-alfa-2a/ribavirin (pegIFN alfa-2a/RBV) in treatment-naive black/African American (AA), Latino, and white non-Latino patients with chronic HCV genotype 1 infection. Material and methods. In this single-arm, open-label study, 246 patients received daclatasvir plus pegIFN alfa-2a and weight-based RBV. Patients with an extended rapid virologic response (eRVR; undetectable HCV-RNA at treatment weeks 4 and 12) received 24 weeks of treatment; those without eRVR received an additional 24 weeks of treatment with pegIFN alfa-2a/RBV. The primary endpoint was sustained virologic response at post-treatment week 12 (SVR12; HCV-RNA < 25 IU/mL) compared with the cohort historical rate. Results. Most patients were IL28B non-CC (84.4% black/AA; 77.6% Latino) genotype 1a-infected (72.7%; 81.3%), with HCV-RNA ≥ 800,000 IU/mL (81.3%; 64.5%). SVR12 rates were 50.8% (65/128; 95% confidence interval [CI], 42.1-59.4) for black/AA and 58.9% (63/107; 95% CI, 49.6-68.2) for Latino patients. The majority (55.5%; 58.9%) received 24 weeks treatment; rapid reductions (> 4-log10) in HCV-RNA levels were observed. Only 60.9% (78/128) of black/AA and 63.6% (68/107) of Latino patients completed treatment. On-treatment serious adverse events (SAEs) occurred in 21 patients. Discontinuations due to adverse events (AEs) occurred in 9 black/AA and 6 Latino patients. Conclusion. SVR12 rates for black/AA (50.8%) and Latino (58.9%) cohorts treated with daclatasvir plus pegIFN alfa-2a/RBV and the lower bound of the 95% CIs were higher than the estimated historical control (black/AA, 26% SVR; Latino, 36% SVR) treated with pegIFN alfa-2a/RBV. These data support daclatasvir use in all-oral direct-acting antiviral combinations. [ABSTRACT FROM AUTHOR]

Background Careful surgical management of traumatic wounds is important in open globe injury repair. This study examines the clinical outcomes following repair of open globe injuries with particular focus on wound-related issues. Design Retrospective, cohort study of consecutive open globe injuries presenting to a tertiary referral eye hospital from 1 January 2009 to 31 December 2011. Participants A total of 267 eyes of 263 patients, mainly male (82.5%) with a mean age of 44.8 (range: 4-97) years. Average follow up was 6.9 months. Methods All cases classified according to Ocular Trauma Classification Group. Main Outcome Measures Visual outcomes, risk factors for and rates of postoperative complications and endophthalmitis. Results There were 83 globe ruptures, 182 penetrating and 2 perforating eye injuries, of which 43 cases had intraocular foreign body. Factors contributing to final visual acuity ( VA) <6/60 were poor presenting VA (odds ratio [ OR] = 16.0, 95% confidence interval [ CI]: 4.81-53.1), globe rupture ( OR = 4.64, [1.99-10.8]), retinal detachment ( OR = 3.40, [1.19-9.74]) and age ≥50 ( OR = 2.45, [1.05-5.74]). Wound leak occurred in 44 eyes (16%). Of these, 18 (41%) proceeded to re-suturing. Factors contributing to wound leak were stellate-shaped wound ( OR = 3.28, [1.39-7.73]) and delayed presentation ( OR = 2.80, [1.02-7.71]). Ten eyes (3.7%) developed endophthalmitis. Factors associated with endophthalmitis were delayed presentation ( OR = 8.91, [1.71-46.6]), microbial keratitis ( OR = 12.5, [1.85-85.0]) and lens capsule breach ( OR = 12.4, [1.85-83.1]). Conclusions Wound leak is an important postoperative complication of open globe injury repair. Delayed presentation is an important risk factor for postoperative wound leak and endophthalmitis. Prompt and meticulous wound management of open globe injury may reduce these complications. [ABSTRACT FROM AUTHOR]

Background: External hemipelvectomy is associated with high post operative morbidity and a poor functional outcome. We aim to explore a reconstruction technique to improve function and post operative appearance for patients who undergo external hemipelvectomy. Case presentation: We present a Case where extensive cancer involvement of pelvis and femur was managed with a novel surgical technique, which involved a calf sparing modified anterior flap hemipelvectomy combined with rotationplasty of the spared calf and fixation of calcaneus to the sacrum, thereby recreating a new thigh stump. Conclusion: Tibia-hindfoot rotationplasty result in good functional outcome and appearance for selected patients undergoing external hemipelvectomy with unaffected external iliac and femoral vessels. [ABSTRACT FROM AUTHOR]