ABSTRACT Methods of causal inference have shown promise in replicating randomised trials using real-world data recorded by Electronic Health Records (EHRs). We herein emulated a target trial on the intention-to-treat efficacy of off-label bevacizumab (q6w) pro re nata relative to fixed-interval aflibercept (q8w) for improving week-54 visual acuity of eyes affected by neovascular age-related macular degeneration. The bevacizumab arm (n 65) was taken from the ABC randomised controlled trial. A total of 4,471 aflibercept-treated eyes aligning with the ABC trial eligibility were identified from EHRs and synthetic control arms were created by emulating randomisation conditional on age, sex, and baseline visual read via exact matching and propensity score methods. We undertook an inferiority analysis on mean difference at 54 weeks; outcomes regression on achieving a change in visual acuity of ≥ 15, ≥ 10, and ≤ −15 Early Treatment Diabetic Retinopathy Letters (ETDRS) letters at week 54; and a time-to-event analysis on achieving a change in visual acuity of ≥ 15, ≥ 10, and ≤ −15 ETDRS letters by week 54. Our findings suggest off-label bevacizumab to be neither non-inferior nor superior to licensed aflibercept. While being no substitute for randomised controlled trials, emulated target trials could aid the interpretation of single-armed trials.
Idiopathic macular holes (IMH) are common and affect central vision. We demonstrate the effectiveness of 0.2 ml intravitreal perfluoropropane (C3F8) in Stage-2 IMH.A 61-year-old woman presented with blurred vision OD. Best-corrected visual acuity (BCVA) was 20/125 OD and 20/20 OS. Biomicroscopy of OD evidenced a Stage-2 IMH. Intravitreal C3F8 was injected and postural measures prescribed. Optical coherence tomography 1 week after revealed posterior vitreous detachment and vitreomacular traction resolution. Full anatomical and functional recovery was achieved at week 4 and remained stable during a 6-month follow-up (BCVA 20/20 OD).Intravitreal C3F8 as initial therapy for Stage 2 IMH represents a good alternative to vitrectomy for patients with IMH.Los agujeros maculares idiopáticos (AMI) son comunes y afectan la visión central. Demostramos la efectividad de 0.2 ml de perfluoropropano (C3F8) intravítreo en AMI en estadio 2.Una mujer de 61 años presentó con visión borrosa súbita OD. Mejor agudeza visual corregida (MAVC) 20/125 OD y 20/20 en el OS. La biomicroscopía del OD evidenció un AMI en estadio 2. Se inyectó C3F8 intravítreo y se prescribieron medidas posturales. Una semana después, la tomografía de coherencia óptica reveló desprendimiento de vítreo posterior. La resolución de tracción vitreomacular con recuperación anatómica y funcional completa se logró a la semana 4 y se mantuvo estable durante un seguimiento de 6 meses (MAVC 20/20 OD).El C3F8 intravítreo como terapia inicial para AMI en estadio 2 representa una buena alternativa a la vitrectomía vía pars plana en pacientes con AMI.
Background Photographic diabetic retinopathy screening requires labour-intensive grading of retinal images by humans. Automated retinal image analysis software (ARIAS) could provide an alternative to human grading. We compare the performance of an ARIAS using true-colour, wide-field confocal scanning images and standard fundus images in the English National Diabetic Eye Screening Programme (NDESP) against human grading. Methods Cross-sectional study with consecutive recruitment of patients attending annual diabetic eye screening. Imaging with mydriasis was performed (two-field protocol) with the EIDON platform (CenterVue, Padua, Italy) and standard NDESP cameras. Human grading was carried out according to NDESP protocol. Images were processed by EyeArt V.2.1.0 (Eyenuk Inc, Woodland Hills, California). The reference standard for analysis was the human grade of standard NDESP images. Results We included 1257 patients. Sensitivity estimates for retinopathy grades were: EIDON images; 92.27% (95% CI: 88.43% to 94.69%) for any retinopathy, 99% (95% CI: 95.35% to 100%) for vision-threatening retinopathy and 100% (95% CI: 61% to 100%) for proliferative retinopathy. For NDESP images: 92.26% (95% CI: 88.37% to 94.69%) for any retinopathy, 100% (95% CI: 99.53% to 100%) for vision-threatening retinopathy and 100% (95% CI: 61% to 100%) for proliferative retinopathy. One case of vision-threatening retinopathy (R1M1) was missed by the EyeArt when analysing the EIDON images, but identified by the human graders. The EyeArt identified all cases of vision-threatening retinopathy in the standard images. Conclusion EyeArt identified diabetic retinopathy in EIDON images with similar sensitivity to standard images in a large-scale screening programme, exceeding the sensitivity threshold recommended for a screening test. Further work to optimise the identification of ‘no retinopathy’ and to understand the differential lesion detection in the two imaging systems would enhance the use of these two innovative technologies in a diabetic retinopathy screening setting.
ABSTRACT Objectives To report the reduction in new neovascular age-related macular degeneration (nAMD) referrals during the COVID-19 pandemic and estimate the impact of delayed treatment on visual outcomes at one year. Design Retrospective clinical audit and simulation model. Setting Multiple UK NHS ophthalmology centres. Participants Data on the reduction in new nAMD referrals was obtained from four NHS Trusts in England comparing April 2020 to April 2019. To estimate the potential impact on one-year visual outcomes, a stratified bootstrap simulation model was developed drawing on an electronic medical records dataset of 20,825 nAMD eyes from 27 NHS Trusts. Main outcome measures Simulated mean visual acuity and proportions of eyes with vision ≤6/60, ≤6/24 and ≥6/12 at one year under four hypothetical scenarios: no treatment delay, 3, 6 and 9-month treatment delays. Estimated additional number of eyes with vision ≤6/60 at one year nationally. Results The number of nAMD referrals at four major eye treatment hospital groups based in England dropped on average by 72% (range 65 to 87%) in April 2020 compared to April 2019. Simulated one-year visual outcomes for 1000 nAMD eyes with a 3-month treatment delay suggested an increase in the proportion of eyes with vision ≤6/60 from 15.5% (13.2 to 17.9) to 23.3% (20.7 to25.9), and a decrease in the proportion of eyes with vision ≥6/12 (driving vision) from 35.1% (32.1 to 38.1) to 26.4% (23.8 to29.2). Outcomes worsened incrementally with longer modelled delays. Assuming nAMD referrals are reduced to this level at the national level for only one month, these simulated results suggest an additional 186-365 eyes with vision ≤6/60 at one-year with even a short treatment delay. Conclusions We report a large decrease in nAMD referrals during the first month of COVID-19 lockdown and provide an important public health message regarding the risk of delayed treatment. As a conservative estimate, a treatment delay of 3 months could lead to a >50% relative increase in the number of eyes with vision ≤6/60 and 25% relative decrease in the number of eyes with driving vision at one year.
Introduction The English National Health Service (NHS) Diabetic Eye Screening Programme (DESP) performs around 2.3 million eye screening appointments annually, generating approximately 13 million retinal images that are graded by humans for the presence or severity of diabetic retinopathy. Previous research has shown that automated retinal image analysis systems, including artificial intelligence (AI), can identify images with no disease from those with diabetic retinopathy as safely and effectively as human graders, and could significantly reduce the workload for human graders. Some algorithms can also determine the level of severity of the retinopathy with similar performance to humans. There is a need to examine perceptions and concerns surrounding AI-assisted eye-screening among people living with diabetes and NHS staff, if AI was to be introduced into the DESP, to identify factors that may influence acceptance of this technology. Methods and analysis People living with diabetes and staff from the North East London (NEL) NHS DESP were invited to participate in two respective focus groups to codesign two online surveys exploring their perceptions and concerns around the potential introduction of AI-assisted screening. Focus group participants were representative of the local population in terms of ages and ethnicity. Participants’ feedback was taken into consideration to update surveys which were circulated for further feedback. Surveys will be piloted at the NEL DESP and followed by semistructured interviews to assess accessibility, usability and to validate the surveys. Validated surveys will be distributed by other NHS DESP sites, and also via patient groups on social media, relevant charities and the British Association of Retinal Screeners. Post-survey evaluative interviews will be undertaken among those who consent to participate in further research. Ethics and dissemination Ethical approval has been obtained by the NHS Research Ethics Committee (IRAS ID: 316631). Survey results will be shared and discussed with focus groups to facilitate preparation of findings for publication and to inform codesign of outreach activities to address concerns and perceptions identified.
Imaging techniques of the posterior segment of the eye have gradually evolved and tremendously improved during the last decade. A widespread implementation of optical coherence tomography (OCT) for the management and diagnosis of retinal conditions, with a concurrent advance in integrative technology, led to the integration of the OCT into the microscope for its intraoperative use. Regarding posterior segment eye surgery, some of the most common diagnoses in which microscope-integrated OCT (MIOCT) can result of great value are epiretinal membrane, macular hole (MH), proliferative diabetic retinopathy (PDR) and, less frequently, for inflammatory diseases, chorioretinal biopsies, and retinal implants. The impact on the surgical procedure and, possibly, on the postoperative outcome could relate to the definition of whether or not a membrane has been entirely peeled, the presence of residual membranes, and the option to perform a dissection without the need of vital dyes. The possibility of correct topographical location of hemorrhages, suspect lesions, or implants can also facilitate the surgical decision-making during biopsies or prosthesis implantation. Microscope-integrated OCT is a feasible and useful tool that can provide valuable information during surgery impact on decision-making, anatomic results, surgical safety and provide opportunity to individualize surgical treatment for each patient.
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