Study protocol: optical coherence tomography angiography for the detection of neovascular age-related macular degeneration: a comprehensive multicentre diagnostic accuracy study in the UK-the ATHENA study.

INTRODUCTION: The diagnosis of neovascular age-related macular degeneration (nAMD), the leading cause of visual impairment in the developed world, relies on the interpretation of various imaging tests of the retina. These include invasive angiographic methods, such as Fundus Fluorescein Angiography (FFA) and, on occasion, Indocyanine-Green Angiography (ICGA). Newer, non-invasive imaging modalities, predominately Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA), have drastically transformed the diagnostic approach to nAMD. The aim of this study is to undertake a comprehensive diagnostic accuracy assessment of the various imaging modalities used in clinical practice for the diagnosis of nAMD (OCT, OCTA, FFA and, when a variant of nAMD called Polypoidal Choroidal Vasculopathy is suspected, ICGA) both alone and in various combinations. METHODS AND ANALYSIS: This is a non-inferiority, prospective, randomised diagnostic accuracy study of 1067 participants. Participants are patients with clinical features consistent with nAMD who present to a National Health Service secondary care ophthalmology unit in the UK. Patients will undergo OCT as per standard practice and those with suspicious features of nAMD on OCT will be approached for participation in the study. Patients who agree to take part will also undergo both OCTA and FFA (and ICGA if indicated). Interpretation of the imaging tests will be undertaken by clinicians at recruitment sites. A randomised design was selected to avoid bias from consecutive review of all imaging tests by the same clinician. The primary outcome of the study will be the difference in sensitivity and specificity between OCT+OCTA and OCT+FFA (±ICGA) for nAMD detection as interpreted by clinicians at recruitment sites. ETHICS AND DISSEMINATION: The study has been approved by the South Central-Oxford B Research Ethics Committee with reference number 21/SC/0412.Dissemination of study results will involve peer-review publications, presentations at major national and international scientific conferences. TRIAL REGISTRATION NUMBER: ISRCTN18313457.

Practical implementation of a q4-q16 aflibercept treat-and-extend pathway for the treatment of neovascular age-related macular degeneration: Updated guidance from a UK expert panel.

OBJECTIVES: This report, based on guidance from a panel of UK retina specialists, introduces a revised intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) pathway for the treatment of neovascular age-related macular degeneration (nAMD). The T&E pathway incorporates the updated IVT-AFL label (April 2021) allowing flexible treatment intervals of 4 weeks to 16 weeks, after three initiation doses and a further dose after 8 weeks. Practical guidance is provided on the clinical implementation of the revised pathway, with the aim of supporting clinical decision-making to benefit patients and addressing capacity issues in nAMD services. METHODS: Three structured round-table meetings of UK retina specialists were held online on 19 May, 16 June and 13 October 2021. These meetings were organised and funded by Bayer. RESULTS: The authors revised the previously published consensus pathway to reflect the changes to the IVT-AFL label and developed guidelines for the implementation of the pathway in UK clinical practice. The guidelines include topics such as recommendations for extending patients with 2- or 4-week adjustments, extending patients to 16-week treatment intervals, managing fellow eye involvement, and reducing treatment intervals for patients with particularly active disease. CONCLUSIONS: The revised IVT-AFL T&E nAMD pathway offers guidance to clinicians seeking to increase the dosing flexibility of IVT-AFL, with 4- to 16-week treatment intervals, in line with the updated IVT-AFL label, to meet the continually evolving demands of nAMD service provision.

Teleophthalmology-enabled and artificial intelligence-ready referral pathway for community optometry referrals of retinal disease (HERMES): a Cluster Randomised Superiority Trial with a linked Diagnostic Accuracy Study-HERMES study report 1-study protocol.

INTRODUCTION: Recent years have witnessed an upsurge of demand in eye care services in the UK. With a large proportion of patients referred to Hospital Eye Services (HES) for diagnostics and disease management, the referral process results in unnecessary referrals from erroneous diagnoses and delays in access to appropriate treatment. A potential solution is a teleophthalmology digital referral pathway linking community optometry and HES. METHODS AND ANALYSIS: The HERMES study (Teleophthalmology-enabled and artificial intelligence-ready referral pathway for community optometry referrals of retinal disease: a cluster randomised superiority trial with a linked diagnostic accuracy study) is a cluster randomised clinical trial for evaluating the effectiveness of a teleophthalmology referral pathway between community optometry and HES for retinal diseases. Nested within HERMES is a diagnostic accuracy study, which assesses the accuracy of an artificial intelligence (AI) decision support system (DSS) for automated diagnosis and referral recommendation. A postimplementation, observational substudy, a within-trial economic evaluation and discrete choice experiment will assess the feasibility of implementation of both digital technologies within a real-life setting. Patients with a suspicion of retinal disease, undergoing eye examination and optical coherence tomography (OCT) scans, will be recruited across 24 optometry practices in the UK. Optometry practices will be randomised to standard care or teleophthalmology. The primary outcome is the proportion of false-positive referrals (unnecessary HES visits) in the current referral pathway compared with the teleophthalmology referral pathway. OCT scans will be interpreted by the AI DSS, which provides a diagnosis and referral decision and the primary outcome for the AI diagnostic study is diagnostic accuracy of the referral decision made by the Moorfields-DeepMind AI system. Secondary outcomes relate to inappropriate referral rate, cost-effectiveness analyses and human-computer interaction (HCI) analyses. ETHICS AND DISSEMINATION: Ethical approval was obtained from the London-Bromley Research Ethics Committee (REC 20/LO/1299). Findings will be reported through academic journals in ophthalmology, health services research and HCI. TRIAL REGISTRATION NUMBER: ISRCTN18106677 (protocol V.1.1).

Birdshot chorioretinopathy: current knowledge and new concepts in pathophysiology, diagnosis, monitoring and treatment.

Birdshot chorioretinopathy (BCR) is a rare form of chronic, bilateral, posterior uveitis with a distinctive clinical phenotype, and a strong association with HLA-A29. It predominantly affects people in middle age. Given its rarity, patients often encounter delays in diagnosis leading to delays in adequate treatment, and thus risking significant visual loss. Recent advances have helped increase our understanding of the underlying autoimmune mechanisms involved in disease pathogenesis, and new diagnostic approaches such as multimodality imaging have improved our ability to both diagnose and monitor disease activity. Whilst traditional immunosuppressants may be effective in BCR, increased understanding of immune pathways is enabling development of newer treatment modalities, offering the potential for targeted modulation of immune mediators. In this review, we will discuss current understanding of BCR and explore recent developments in diagnosis, monitoring and treatment of this disease. Synonyms for BCR: Birdshot chorioretinopathy, Birdshot retinochoroiditis, Birdshot retino-choroidopathy, Vitiliginous choroiditis. Orphanet number: ORPHA179 OMIM: 605808.

Photorefractive keratectomy (PRK) versus laser assisted in situ keratomileusis (LASIK) for hyperopia correction.

BACKGROUND: Hyperopia, or hypermetropia (also known as long-sightedness or far-sightedness), is the condition where the unaccommodating eye brings parallel light to a focus behind the retina instead of on it. Hyperopia can be corrected with both non-surgical and surgical methods, among them photorefractive keratectomy (PRK) and laser assisted In situ keratomileusis (LASIK). There is uncertainty as to whether hyperopic-PRK or hyperopic-LASIK is the better method. OBJECTIVES: The objectives of this review were to determine whether PRK or LASIK leads to more reliable, stable and safe results when correcting a hyperopic refractive error. SEARCH METHODS: We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2012, Issue 2), MEDLINE (January 1950 to February 2012), EMBASE (January 1980 to February 2012), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to February 2012), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The electronic databases were last searched on 17 February 2012. When trials are included in the review we will search the reference lists of the studies included in the review for information about further trials. We will use the Science Citation Index to search for papers that cite any studies included in this review. We did not handsearch journals or conference proceedings specifically for this review. SELECTION CRITERIA: We planned to include only randomised controlled trials (RCTs) comparing PRK against LASIK for correction of hyperopia and then perform a sensitivity analysis of pre- and post-millennial trials since this is the mid-point in the history of both PRK and LASIK. DATA COLLECTION AND ANALYSIS: We did not identify any studies that met the inclusion criteria for this review. MAIN RESULTS: As no studies met the inclusion criteria for this review, we discussed the results of non-randomised trials comparing hyperopic-PRK with hyperopic-LASIK. AUTHORS' CONCLUSIONS: No robust, reliable conclusions could be reached, but the non-randomised trials reviewed appear to be in agreement that hyperopic-PRK and hyperopic-LASIK are of comparable efficacy. High quality, well-planned open RCTs are needed in order to obtain a robust clinical evidence base.

Outcomes of refractive surgery in patients with topographic superior corneal steepening.

PURPOSE: To evaluate the outcomes of refractive surgery in patients with topographic superior corneal steepening. METHODS: This retrospective, noncomparative, interventional, clinical study included 16 patients (29 eyes) with persistent superior corneal steepening as a variation of corneal curvature (inferior to superior topographic corneal difference of at least 1.00 diopter [D] at a 3-mm zone) not related to any underlying disease or condition who underwent corneal refractive surgery. Refractive, keratometric, and visual outcomes were evaluated preoperatively and at 1, 3, 6, 12, and 24 months postoperatively. RESULTS: Twenty-two eyes underwent photorefractive keratectomy and 7 eyes underwent LASIK. Mean follow-up was 27.38±2.37 months (range: 25 to 32 months). Mean preoperative inferior to superior keratometric difference was 1.61±0.36 D (range: 1.20 to 2.63 D). Mean preoperative spherical equivalent refraction was -4.45±1.66 D (range: -2.25 to -8.00 D), which decreased to -0.09±0.61 D (range: +0.75 to -1.38 D) (P<.05) at last follow-up. Mean preoperative topographic corneal astigmatism was 1.44±0.79 D (range: 0.52 to 3.83 D), which decreased to 0.66±0.39 D (P<.05) 3 months postoperatively and remained stable during follow-up (P<.54). Mean preoperative uncorrected distance visual acuity and corrected distance visual acuity in logMAR units were 1.57±0.62 and 0.02±0.06, respectively, which improved at last follow-up to 0.00±0.05 and -0.02±0.04, respectively. No intra- or postoperative complications were noted; specifically, no patients developed postoperative ectasia. CONCLUSIONS: Corneal refractive surgery in patients with isolated topographic superior corneal steepening provided acceptable refractive and visual outcomes without any intra- or postoperative complications. Diligence is required to screen for the potential of ectatic corneal disorders in this population. Photorefractive keratectomy may be a safer option for these patients than LASIK.

Macular retinal and nerve fiber layer thickness in early glaucoma: clinical correlations.

PURPOSE: Previous studies have evaluated macular retinal thickness (RT) and nerve fiber layer thickness (RNFLT) changes in early glaucoma using elaborate optical coherence tomography (OCT) scanning protocols. MATERIALS AND METHODS: This study examines RT and RNFLT using standard scanning protocols in early glaucoma. In this prospective, nonrandomized case series, 95 eyes of 95 patients were evaluated, including 29 nonglaucomatous subjects (control group), 34 glaucoma suspects, and 32 early manifest glaucoma patients. RT and RNFLT were measured using scanning fast macular thickness map and Fast RNFLT (3.4) protocols on a 1.70 mm radius around the macular center (respectively) in all four quadrants. The fast RNFLT (3.4) protocol was transposed on the macula from the peri-papillary area. Data were statistically analyzed for differences between groups, and for correlations between parameters. P<0.5 was statistically significant. RESULTS: Both early manifest glaucoma patients and glaucoma suspects had significantly lower RT than controls in all quadrants. RNFLT differences in all quadrants were not statistically significant (P>0.05). RT was significantly inversely correlated with axial length in early manifest glaucoma patients and glaucoma suspects but not in controls. CONCLUSIONS: The finding that RT was significantly lower in early manifest glaucoma patients and glaucoma suspects indicates that the transposition of the OCT fast RNFL thickness (3.4) protocol from the peri-papillary area to the peri-macular area can be used for early glaucoma diagnosis. Intraretinal changes in early glaucoma, likely precede nerve fiber changes.

Lamellar retinal hole formation following routine cataract surgery.

We present a case of a retinal hole detected after routine cataract surgery and discuss possible pathogenetic mechanisms of this complication.