Outcomes and Baseline Predictors of Failure in Primary Standalone Xen45 Gel Stent versus Trabeculectomy for Glaucoma.

PURPOSE: To compare safety, effectiveness, and baseline predictors of failure in standalone primary Xen45 gel stent (Xen) versus trabeculectomy (Trab) in glaucoma. DESIGN: Retrospective study. SUBJECTS: Subjects that underwent primary Xen or Trab augmented by mitomycin-C with at least 12 months follow-up. METHODS: Multinational observational study of eyes in the Fight Glaucoma Blindness international registry MAIN OUTCOME MEASURES: The primary outcome was success at 12 months defined by intraocular pressure (IOP) reduction ≥ 20% from baseline and ≤ threshold IOPs of 15, 18, and 21 mmHg with (qualified) or without (complete) medications and without secondary glaucoma surgery. Multivariable mixed effects Cox regression models were used to identify risk factors for failure in each cohort. RESULTS: A total of 701 eyes (Xen, 308; Trab, 393) of 596 subjects were included with baseline IOP being significantly higher (22.4 vs. 19.9 mmHg, P < 0.001) and baseline medications significantly lower in the Xen versus the Trab group (2.9 vs. 3.4, P < 0.001). Baseline visual field mean deviation was less severe in the Xen group (-9.47 vs. -13.04 dB, P < 0.001). The proportion of complete surgical success was significantly lower in the Xen versus Trab group across the 3 upper IOP limits at 12 months; 32% versus 52% at 15 mmHg, 37% versus 54% at 18 mmHg, and 39% versus 55% at 21 mmHg (P < 0.001). The incidence of postoperative numerical and symptomatic hypotony was lower in the Xen versus Trab group. In the Xen cohort, a higher failure rate was associated with Asian ethnicity (hazard ratio [HR], 1.97; 95% confidence interval (CI), 1.03-3.79) and use of oral acetazolamide at baseline (HR, 1.74; 95% CI, 1.13-2.70), whereas a lower failure rate was associated with diagnosis of ocular hypertension/open-angle glaucoma suspect (HR, 0.40; 95% CI, 0.20-0.82) and secondary open-angle glaucoma (HR, 0.46; 95% CI, 0.26-0.82). Exposure to prostaglandin analog was associated with greater failure in the Trab group (HR, 2.66; 95% CI, 1.18-6.01). CONCLUSIONS: There was significantly greater complete success at 12 months across all complete success definitions for Trab compared with Xen, whereas the rate of postoperative hypotony was significantly lower in the Xen group. Asian ethnicity and use of oral acetazolamide at baseline were associated with greater failure in Xen, whereas exposure to prostaglandin analog was associated with greater failure in Trab patients. Such baseline predictors of success and failure may help guide patient selection for subconjunctival minimally invasive glaucoma surgery in patients undergoing surgical intervention. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Glaucoma severity at first presentation to an ophthalmologist and risk factors for late presentation in rural Australia: the S1P study.

CLINICAL RELEVANCE: Well-targeted referrals and timely commencement of treatment are essential to limiting vision loss in glaucoma. Optometrists, primary care providers, and public health policymakers can utilise predictors of late to identify and target at-risk populations. BACKGROUND: This study, which aimed to evaluate glaucoma severity at first presentation to an ophthalmologist in a rural Australian population, is the first of its kind in an Australian population. METHODS: Patient records from a large ophthalmology clinic in Port Macquarie, NSW were retrospectively reviewed using the Fight Glaucoma Blindness registry to identify patients who were first diagnosed with glaucoma at an ophthalmology practice in 2020 or 2021. Associations with glaucoma severity at presentation, measured with visual field index (VFI), were analysed using a beta-regression model. Retinal nerve fibre layer measurements were evaluated as a secondary outcome measure using linear regression. RESULTS: From 3548 new patients seen, 110 cases of glaucoma were diagnosed, 95 of whom met inclusion criteria. These comprised 41.8% primary open-angle glaucoma, 32.7% normal-tension glaucoma, 11.8% secondary open-angle glaucoma, 12.7% primary angle closure glaucoma, and 0.9% secondary angle closure glaucoma. The median VFI at presentation was 94.5%, and 71.9% of patients had a VFI ≥ 90%. However, 6.3% of patients presented with a VFI below 50%. Older age, higher intraocular pressure, and worse visual acuity were significantly associated with severity at presentation. No associations were found for remoteness, sex, family history, or glaucoma type. CONCLUSIONS: Glaucoma appears to be diagnosed relatively early in this population. Severity at presentation was associated with age, intraocular pressure, and visual acuity, but not influenced by the social determinants assessed. These findings underscore the importance of frequent comprehensive eye examinations in older patients. Replication in other Australian populations is recommended as the generalisability of these findings is limited.

Two-year outcomes of Xen 45 gel stent implantation in patients with open-angle glaucoma: real-world data from the Fight Glaucoma Blindness registry.

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.

Diabetic Retinopathy Screening at the Point of Care (DR SPOC): detecting undiagnosed and vision-threatening retinopathy by integrating portable technologies within existing services.

INTRODUCTION: The aim of this study was to determine the prevalence of diabetic retinopathy (DR) in a low socioeconomic region of a high-income country, as well as determine the diagnostic utility of point-of-care screening for high-risk populations in tertiary care settings. RESEARCH DESIGN AND METHODS: This was a cross-sectional study of patients with diabetes attending foot ulcer or integrated care diabetes clinics at two Western Sydney hospitals (n=273). DR was assessed using portable, two-field, non-mydriatic fundus photography and combined electroretinogram/ pupillometry (ERG). With mydriatic photographs used as the reference standard, sensitivity and specificity of the devices were determined. Prevalence of DR and vision-threatening diabetic retinopathy (VTDR) were reported, with multivariate logistic regression used to identify predictors of DR. RESULTS: Among 273 patients, 39.6% had any DR, while 15.8% had VTDR, of whom 59.3% and 62.8% were previously undiagnosed, respectively. Non-mydriatic photography demonstrated 20.2% sensitivity and 99.5% specificity for any DR, with a 56.7% screening failure rate. Meanwhile, mydriatic photography produced high-quality images with a 7.6% failure rate. ERG demonstrated 72.5% sensitivity and 70.1% specificity, with a 15.0% failure rate. The RETeval ERG was noted to have an optimal DR cut-off score at 22. Multivariate logistic regression identified an eGFR of ≤29 mL/min/1.73 m2, HbA1c of ≥7.0%, pupil size of <4 mm diameter, diabetes duration of 5-24 years and RETeval score of ≥22 as strong predictors of DR. CONCLUSION: There is a high prevalence of vision-threatening and undiagnosed DR among patients attending high-risk tertiary clinics in Western Sydney. Point-of-care DR screening using portable, mydriatic photography demonstrates potential as a model of care which is easily accessible, targeted for high-risk populations and substantially enhances DR detection.

A Systematic Review of Glaucoma Diagnosis in Prevalence Studies and Quality of Reporting.

PRCIS: This systematic review has revealed that variable definitions of glaucoma continue to be used in prevalence studies, despite the introduction of the International Society of Geographic and Epidemiologic Ophthalmology (ISGEO) criteria. PURPOSE: To systematically review diagnostic criteria and examinations performed in glaucoma prevalence studies over time and determine the quality of reporting. Accurate estimates of glaucoma prevalence are crucial to inform resource allocation. However, diagnosis of glaucoma comprises inherently subjective examinations and the cross-sectional nature of prevalence studies precludes monitoring for progression. METHODS: A systematic review of PubMed, Embase, Web of Science, and Scopus was performed to examine diagnostic protocols used by glaucoma prevalence studies and evaluate uptake of the ISGEO criteria, introduced in 2002 to standardize glaucoma diagnosis in prevalence studies. Detection bias and compliance with the Strengthening Reporting of Observational Studies in Epidemiology (STROBE) guidelines were evaluated. RESULTS: Ten thousand five hundred forty-four articles were identified. After deduplication, 5589 articles were screened, yielding 136 articles pertaining to 123 studies. An absence of data in many countries was identified. Ninety-two percent of studies stated diagnostic criteria, and 62% used the ISGEO criteria since their publication. Weaknesses of the ISGEO criteria were identified. Temporal variations in the performance of various examinations were observed, including heterogeneity in angle assessment. Mean STROBE compliance was 82% (range 59-100%); 72 articles had a low risk of detection bias, 4 had a high risk, and 60 had some concerns. CONCLUSION: Heterogeneous diagnostic definitions persist in glaucoma prevalence studies, despite introduction of the ISGEO criteria. Standardization of criteria remains imperative and the development of new criteria represent a valuable opportunity to achieve this goal. In addition, methods of determining diagnoses are poorly reported, suggesting a need for improvement in study conduct and reporting. Accordingly, we propose the Reporting of quality Of GlaUcoma Epidemiological Studies (ROGUES) Checklist. We have also identified a need for further prevalence studies in regions with limited data and to update Australian angle closure glaucoma prevalence. Design and reporting of future studies can be informed by this review's insights into diagnostic protocols previously used.

Surgical approach to repair of traumatic avulsion and external herniation of the levator palpebrae superioris aponeurosis.

This report describes the unusual case and surgical repair of avulsion and external herniation of the levator palpebrae superioris (LPS) aponeurosis and attached muscle fibres associated with superior tarsal plate fracture in an 8-year-old Indigenous girl. To the authors' knowledge, isolated and complete levator palpebrae superioris avulsion with external herniation in trauma is previously unreported. Open injury to LPS requires swift surgical repair, and an anterior ptosis repair approach may facilitate identification of anatomical structures to prevent upper eyelid ptosis. Ultimately, the surgical repair in this case prevented further ptosis surgery and complications in a paediatric patient.

Optimising fundoscopy practices across the medical spectrum: A focus group study.

INTRODUCTION: Fundoscopy can be of great clinical value, yet remains underutilised. Educational attempts to improve fundoscopy utilisation have had limited success. We aimed to explore the barriers and facilitators underlying the uptake of clinical direct ophthalmoscopy across a spectrum of medical specialties and training levels. METHODS: Ten focus groups were conducted with medical students (n = 42), emergency department doctors (n = 24), basic physician trainees (n = 7), hospital physicians (n = 6) and general practitioners (n = 7). Independent thematic analysis of transcripts was conducted by three investigators. A consensus thematic framework was developed, and transcripts were reanalysed using this framework. RESULTS: Thematic analysis identified seven main themes: (1) technical barriers to performing fundoscopy examinations; (2) clinical culture and expectations regarding fundoscopy; (3) the influence of fundoscopy on clinical management; (4) motivation to perform the examination; (5) novel technology including smartphone fundoscopy, and the value of a digital fundus image; (6) training requirements, and; (7) use of limited resources. CONCLUSION: Our results build a more nuanced picture of the factors which determine fundoscopy utilisation. As current barriers limit practice by clinicians and medical students, expertise and confidence performing and interpreting fundoscopy are lost. This shifts the balance of perceived clinical utility to futility in changing patient management, and reinforces a cycle of reducing fundoscopy utilisation. We identified important cultural barriers such as accepted incompetence, and misperceptions of senior discouragement. Emerging technologies reduce the technical barriers to fundoscopy. Therefore education should: focus on detecting pathology from digital images; clarify the role of fundoscopy in patient management, and; be targeted at key career progression points.

Fundoscopy use in neurology departments and the utility of smartphone photography: a prospective prevalence and crossover diagnostic accuracy study amongst neurology inpatients.

BACKGROUND AND PURPOSE: Although fundoscopy is a crucial part of the neurological examination, it is challenging, under-utilized and unreliably performed. The aim was to determine the prevalence of fundus pathology amongst neurology inpatients and the diagnostic accuracy of current fundoscopy practice compared with systematic screening with smartphone fundoscopy (SF) and portable non-mydriatic fundus photography (NMFP). METHODS: This was a prospective cross-sectional surveillance and diagnostic accuracy study on adult patients admitted under neurology in an Australian hospital. Inpatients were randomized to initial NMFP (RetinaVue 100, Welch Allyn) or SF (D-EYE) followed by a crossover to the alternative modality. Images were graded by neurology doctors, using telemedicine consensus neuro-ophthalmology NMFP grading as the reference standard. Feasibility parameters included ease, comfort and speed. RESULTS: Of 79 enrolled patients, 14.1% had neurologically relevant pathology (seven, disc pallor; one, hypertensive retinopathy; three, disc swelling). The neurology team performed direct ophthalmoscopy in 6.6% of cases and missed all abnormalities. SF had a sensitivity of 30%-40% compared with NMFP (45.5%); however, it had a lower rate of screening failure (1% vs. 13%, p < 0.001), a shorter examination time (1.10 vs. 2.25 min, p < 0.001) and a slightly higher patient comfort rating (9.2 vs. 8/10, p < 0.001). CONCLUSION: Our study demonstrates a clinically significant prevalence of fundus pathology amongst neurology inpatients which was missed by current fundoscopy practices. Portable NMFP screening appears more accurate than SF, whilst both are diagnostically superior to routine fundoscopic practice, feasible and well tolerated by patients.

Impact on patient management of non-mydriatic fundus photography compared to direct ophthalmoscopy in a regional Australian emergency department.

OBJECTIVE: To investigate the management impact of non-mydriatic fundus photography (NMFP) implementation for appropriate ED patients; compare the diagnostic accuracy of direct ophthalmoscopy (DO) and NMFP, and determine the prevalence of fundus pathology in a regional Australian ED. METHODS: This before/after crossover study prospectively enrolled patients presenting with headache, neurological deficit, visual disturbance and/or hypertensive urgency. Patients received DO examination, then separate NMFP examination. Emergency clinicians (ECs) were surveyed on their patient management plans following both DO examination and NMFP imaging. Telemedicine review of NMFP images was performed by an ophthalmologist within 48 h, and any additional management changes were documented. RESULTS: The use of NMFP influenced changes in management in 52 (39%) of 133 enrolled patients (95% confidence interval 31-48%). Of these, 65% were escalations of management due to acute fundus pathology, while 35% were de-escalating changes following normal fundus findings. ECs diagnostic accuracy for acute fundus pathology improved from 0% to 29% sensitivity, and 59% to 84% specificity using DO and NMFP respectively, and telemedicine registrar review increased this to 50% sensitivity and 86% specificity. The period prevalence of acute fundus pathology was 10.5% (95% confidence interval 6-17%). CONCLUSION: The addition of NMFP images can significantly impact the management of ED patients requiring fundus examination, facilitating expedited and optimised patient care. NMFP improves ECs diagnostic acumen for fundus pathology over DO examination and telehealth specialist review is important for diagnostic accuracy. There is a clinically important prevalence of fundus pathology in this regional ED setting.