Publications by authors named "Sobha Sivaprasad"

260 Publications

Retinal structure-function correlation in type 2 diabetes.

Eye (Lond) 2021 Aug 30. Epub 2021 Aug 30.

Shri Bhagwan Mahavir Vitreoretinal Services, SankaraNethralaya, Chennai, India.

Objective: To examine the relationship of visual function as assessed by visual acuity, contrast sensitivity, and multifocal electroretinography (mfERG) to macular structural and microvascular measures on optical coherence tomography (OCT) and angiography (OCTA) in individuals with diabetes.

Methods: This is a prospective observational study conducted at a tertiary eye care centre in India. Right eyes of 121 adults with type 2 diabetes with no diabetic retinopathy (DR), mild or moderate nonproliferative DR (NPDR) were examined. Severe NPDR, proliferative DR and diabetic macular oedema were excluded. Participants underwent assessment of glycated haemoglobin (HbA), blood pressure, best corrected visual acuity (LogMAR), contrast sensitivity (CS), mfERG, ultrawide field fundus photography, OCT and OCTA. Correlations were assessed by Spearman's rank correlation (rho).

Results: Of the total of 121 eyes, 89 had No DR, 32 had mild to moderate NPDR. In the No DR group, the LogMAR acuity was significantly and negatively correlated to central subfoveal thickness (CST) (rho = -0.420), macular vessel density (rho = -0.270) and perfusion (rho = -0.270). (ii) Contrast sensitivity correlated to foveal avascular zone circularity (rho = 0.297); (iii) mfERG P1 response densities were better with higher macular perfusion index (rho = 0.240). In the NPDR group, the LogMAR acuity also showed a significant negative correlation to CST (rho = -0.379). Other correlations were not significant.

Conclusion: Retinal and visual functional changes are evident in diabetic patients with No DR and are correlated to subclinical retinal structural changes detectable using multimodal imaging.
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http://dx.doi.org/10.1038/s41433-021-01761-1DOI Listing
August 2021

Multimodal imaging comparison of polypoidal choroidal vasculopathy between Asian and Caucasian population.

Am J Ophthalmol 2021 Aug 24. Epub 2021 Aug 24.

Singapore Eye Research Institute, Singapore National Eye Centre, 11 Third Hospital Ave, Singapore 168751, Singapore; Duke-NUS Medical School, National University of Singapore, 8 College Rd, Singapore 169857.

Purpose: Differences in multimodal imaging features between Asians and Caucasians eyes may contribute to our understanding of the etiology of the polypoidal choroidal vasculopathy (PCV). The purpose of this study is to compare the multimodal imaging features of Asian and Caucasian eyes with PCV.

Design: Cross-sectional, retrospective, multicenter, observational case series METHODS: : Consecutive treatment naïve patients diagnosed with PCV based on indocyanine green angiography (ICGA) in accordance to published guidelines. Demographic and multimodal imaging findings based on color fundus photography, spectral domain optical coherence tomography, fluorescein angiography and ICGA were graded.

Results: A total of 250 participants with PCV (128 Asians vs 122 Caucasians) were included. Asians presented with lower BCVA (0.7 ± 0.6 vs 0.4 ± 0.3 logMAR, p<0.001) compared to Caucasians. More Asian eyes presented with subretinal hemorrhage (53.9% vs 24.6%, p<0.001) and had larger areas of hemorrhage (7.5 ± 15.2 vs 1.3 ± 3.3 mm, p<0.001). More Asian eyes had pachyvessels (84.4% vs 28.7%, p<0.001), choroidal vascular hyperpermeability (70.3% vs 17.2%, p<0.001) and widespread polypoidal lesions (19.5% vs 8.2%, p=0.005), while Caucasians had more drusen (79.5% versus 49.2%, p=0.02).

Conclusions: Multimodal imaging analysis revealed ethnic differences in disease characteristics of PCV, suggesting pathophysiologic mechanism of the disease vary based on ethnicity.
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http://dx.doi.org/10.1016/j.ajo.2021.08.006DOI Listing
August 2021

Ethnic Disparities in the Development of Sight-Threatening Diabetic Retinopathy in a UK Multi-Ethnic Population with Diabetes: An Observational Cohort Study.

J Pers Med 2021 Jul 28;11(8). Epub 2021 Jul 28.

UCL Institute of Ophthalmology, 11-43 Bath Street, London EC1V 9EL, UK.

There is little data on ethnic differences in incidence of DR and sight threatening DR (STDR) in the United Kingdom. We aimed to determine ethnic differences in the development of DR and STDR and to identify risk factors of DR and STDR in people with incident or prevalent type II diabetes (T2DM). We used electronic primary care medical records of people registered with 134 general practices in East London during the period from January 2007-January 2017. There were 58,216 people with T2DM eligible to be included in the study. Among people with newly diagnosed T2DM, Indian, Pakistani and African ethnic groups showed an increased risk of DR with Africans having highest risk of STDR compared to White ethnic groups (HR: 1.36 95% CI 1.02-1.83). Among those with prevalent T2DM, Indian, Pakistani, Bangladeshi and Caribbean ethnic groups showed increased risk of DR and STDR with Indian having the highest risk of any DR (HR: 1.24 95% CI 1.16-1.32) and STDR (HR: 1.38 95% CI 1.17-1.63) compared with Whites after adjusting for all covariates considered. It is important to optimise prevention, screening and treatment options in these ethnic minority groups to avoid health inequalities in diabetes eye care.
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http://dx.doi.org/10.3390/jpm11080740DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8400788PMC
July 2021

Incidence and risk factors for macular atrophy in Acquired Vitelliform Lesions.

Ophthalmol Retina 2021 Aug 11. Epub 2021 Aug 11.

University College London, Institute of Ophthalmology, London, EC1V 9EL, UK; NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, UK. Electronic address:

Purpose: To study the time course to macular atrophy (MA) and associated risk factors in eyes with Acquired Vitelliform Lesions (AVL) as they vary between patients and between eyes of an individual.

Design: Single centre, retrospective, observational cohort study.

Subjects: Consecutive patients registered between Jan 2009 to Jan 2014 with first diagnosis of AVL confirmed by multimodal imaging were included. Eyes with baseline MA or choroidal neovascularization were excluded.

Methods: Patient demographics were collected. Serial optical coherence tomography (OCT) scans and fundus autofluorescence (FAF) were graded and analysed. Turnbull's estimator was employed, and time censored at 5 years. Multivariable Weibull parametric proportional hazards models was used to assess association of risk factors with MA, following adjustment for age and gender. Hazard ratios are reported with 95% CI.

Main Outcome Measure: Time to the first OCT evidence of MA stratified by presenting visual acuity (VA) and AVL lesion subtypes. Secondary outcome included risk factors for incident MA.

Results: A total of 237 eyes (132 patients) met the inclusion criteria. Incident MA was detected in 52/237 (21.9%) eyes by 5 years. Stratified by baseline VA, 40.3%eyes with VA≤ 70 letters developed atrophy within 5 years of first diagnosis in contrast to 10.3% eyes with VA>70 letters (p<0.001). Based on lesion type only 12.9% eyes with vitelliform lesion at baseline developed MA versus 39.8% and 44.2% eyes with pseudohypopyon or vitelliruptive lesion type respectively. In adjusted analysis, baseline factors associated with increased risk of MA included VA≤70 letters (HR 5.54; 95% CI 2.30-13.34), base width (HR 1.22; 95% CI 1.16-1.28), maximum height (HR 2.61; 95% CI 1.82-3.74), presence of SDD (HR 2.83; 95% CI 1.34 -5.96) and disrupted external limiting membrane (HR 2.81; 95% CI 1.34-5.86).

Conclusion: Baseline VA of 70 letters or less (Snellen ≤20/40) and pseudohypopyon or vitelliruptive lesion type attribute highest risk for MA. Other prognostic indicators for MA include baseline presence of SDD, disrupted ELM and larger lesion area.
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http://dx.doi.org/10.1016/j.oret.2021.07.009DOI Listing
August 2021

Durability of anti-vascular endothelial growth factor agents in neovascular age-related macular degeneration.

Authors:
Sobha Sivaprasad

Clin Exp Ophthalmol 2021 Aug;49(6):540-541

NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, UK.

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http://dx.doi.org/10.1111/ceo.13973DOI Listing
August 2021

Survival analysis following enucleation for uveal melanoma.

Eye (Lond) 2021 Aug 2. Epub 2021 Aug 2.

Department of Ocular Oncology, Moorfields Eye Hospital, London, UK.

Objectives: To determine survival outcomes following enucleation for uveal melanoma. To compare these outcomes with the 8th edition AJCC classification and determine the influence of cytogenetics, using Fluorescent in situ Hybridisation (FISH), on survival. To determine whether failure to gain sufficient sample for cytogenetics using Fine Needle Aspiration Biopsy (FNAB) correlates with survival.

Subjects/methods: All patients undergoing primary enucleation for uveal melanoma at Moorfields Eye Hospital between 2012 and 2015 were included. Clinical, pathological, cytological and survival data were analysed for all patients.

Results: In total, 155 subjects were included. Mean age at enucleation was 65.9 years (SD 14.13). 88 (56.8%) patients died at a mean of three (SD 1.9) years following enucleation. Of these, 52 (33.5%) died from metastatic melanoma, 16 (10.3%) from other causes and 20 (12.9%) causes of death were unknown. Cumulative incidence analysis demonstrated AJCC grade, chromosome 8q gain and monosomy three all predict metastatic mortality. The greatest 5-year mortality rate (62%, SD10.1%) was in those with both chromosome abnormalities and AJCC stage III (Stage IV patients excluded due to low numbers). Largest basal diameter and chromosome status, both independently (p = 0.02 and p < 0.001) predicted metastatic mortality on multivariable regression analysis. Those who had an insufficient sample of cells gained during FNAB (n = 16) had no different prognosis.

Conclusions: This study confirms, in this population, the poor survival of patients enucleated for uveal melanomas. It confirms the prognostic utility of adding AJCC grade to cytogenetic information. It demonstrates that the lack of sample in patients undergoing FNAB is not related to prognosis.
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http://dx.doi.org/10.1038/s41433-021-01710-yDOI Listing
August 2021

Early detection of neovascular age-related macular degeneration: an economic evaluation based on data from the EDNA study.

Br J Ophthalmol 2021 Aug 2. Epub 2021 Aug 2.

Health Economics Research Unit, University of Aberdeen, Aberdeen, UK

Background/aims: To evaluate the cost-effectiveness of non-invasive monitoring tests to detect the onset of neovascular age-related macular degeneration (nAMD) in the unaffected second eye of patients receiving treatment for unilateral nAMD in a UK National Health Service (NHS) hospital outpatient setting.

Methods: A patient-level state transition model was constructed to simulate the onset, detection, and treatment of nAMD in the second eye. Five index tests were compared: self-reported change in visual function, Amsler test, clinic measured change in visual acuity from baseline, fundus assessment by clinical examination or colour photography, and spectral domain optical coherence tomography (SD-OCT). Diagnosis of nAMD was confirmed by fundus fluorescein angiography (FFA) before prompt initiation of antivascular endothelial growth factor treatment. Quality-adjusted life-years (QALYs) and costs of health and social care were modelled over a 25-year time horizon.

Results: SD-OCT generated more QALYs (SD-OCT, 5.830; fundus assessment, 5.787; Amsler grid, 5.736, patient's subjective assessment, 5.630; and visual acuity, 5.600) and lower health and social care costs (SD-OCT, £19 406; fundus assessment, £19 649; Amsler grid, £19 751; patient's subjective assessment, £20 198 and visual acuity, £20 444) per patient compared with other individual monitoring tests. Probabilistic sensitivity analysis indicated a high probability (97%-99%) of SD-OCT being the preferred test across a range of cost-effectiveness thresholds (£13 000-£30 000) applied in the UK NHS.

Conclusions: Early treatment of the second eye following FFA confirmation of SD-OCT positive findings is expected to maintain better visual acuity and health-related quality of life and may reduce costs of health and social care over the lifetime of patients.
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http://dx.doi.org/10.1136/bjophthalmol-2021-319506DOI Listing
August 2021

Diagnostic Accuracy of Monitoring Tests of Fellow Eyes in Patients with Unilateral Neovascular Age-Related Macular Degeneration: Early Detection of Neovascular Age-Related Macular Degeneration Study.

Ophthalmology 2021 Jul 28. Epub 2021 Jul 28.

Centre for Public Health, Queen's University Belfast, Belfast, Ireland. Electronic address:

Purpose: To evaluate the diagnostic accuracy of routinely used tests of visual function and retinal morphology compared with fundus fluorescein angiography (FFA) to detect onset of active macular neovascularization in unaffected fellow eyes of patients with unilateral neovascular age-related macular degeneration (nAMD).

Design: Prospective diagnostic accuracy cohort study conducted in 24 eye clinics in the United Kingdom over 3 years.

Participants: Older adults (>50 years) with recently diagnosed unilateral nAMD with a fellow (study) eye free of nAMD.

Methods: Self-reported vision, Amsler, clinic-measured visual acuity (VA), fundus assessment, and spectral domain OCT. The reference standard is FFA.

Main Outcome Measures: Sensitivity and specificity of the 5 index tests.

Results: Of 552 participants monitored for up to 3 years, 145 (26.3%) developed active nAMD in the study eye, of whom 120 had an FFA at detection and constituted the primary analysis cohort. Index test positives at nAMD detection in those confirmed by FFA were self-reported vision much worse (5), distortion on Amsler (33), 10-letter decrease in acuity from baseline (36), fundus examination (64), and OCT (110). Percentage index test sensitivities were: self-reported vision 4.2 (95% confidence interval [CI], 1.6-9.8); Amsler 33.7 (95% CI, 25.1-43.5); VA 30.0 (95% CI, 22.5-38.7); fundus examination 53.8 (95% CI, 44.8-62.5); and OCT 91.7 (95% CI, 85.2-95.6). All 5 index test specificities were high at 97.0 (95% CI, 94.6-98.5), 81.4 (95% CI, 76.4-85.5), 66.3 (95% CI, 61.0-71.1), 97.6 (95% CI, 95.3-98.9), and 87.8 (95% CI, 83.8-90.9), respectively. The combination of OCT with one other index test that was a secondary outcome measure increased sensitivity marginally and decreased specificity for all combinations except fundus examination.

Conclusions: Tests of self-reported change in vision, unmasking of new distortion, measurements of acuity, and fundus checks to diagnose active nAMD performed poorly in contrast to OCT. Our findings support a change to guidelines in clinical practice to monitor for onset of nAMD.
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http://dx.doi.org/10.1016/j.ophtha.2021.07.025DOI Listing
July 2021

Microvascular changes precede visible neurodegeneration in fellow eyes of patients with asymmetric type 2 macular telangiectasia.

Eye (Lond) 2021 Jul 29. Epub 2021 Jul 29.

NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital, NHS Foundation, London, United Kingdom.

Importance: Macular telangiectasia type 2 (MacTel) is bilateral disease with characteristic alterations of the macular capillary network along with decreased macular pigment in the parafoveal area. The purpose of this study was to highlight that some eyes show microvascular changes which precede any visible neuronal changes on spectral-domain optical coherence tomography (SD-OCT).

Methods: This observational study was conducted at a tertiary eye institute. From a registry of 630 patients with MacTel, we identified 4 patients with typical MacTel characteristics in only one eye with no visible changes on colour photographs or SD-OCT in the fellow eye. These 4 patients had findings of MacTel documented by colour fundus photograph, multicolour imaging (MCI), fundus autofluorescence (FAF), confocal blue reflectance (CBR), SD-OCT, and OCT-Angiography (OCT-A) in one eye. OCT-A was performed in MacTel patients using the High-resolution Spectralis (Heidelberg Engineering) module with a full-spectrum probabilistic approach and we employed a 30° x 15° (~8.8 mm × 4.4 mm) scan pattern covering the macula. MCI was done at the end so as to avoid fading the confocal blue reflectance hyperreflectivity seen in MacTel.

Results: On OCT-A, all 4 fellow eyes showed telangiectasia and foveal avascular zone changes in the superficial and deep capillary plexuses with no changes on SD-OCT. None of the eyes showed typically increased reflectance on CBR around the foveal area.

Conclusion: These findings show that microvascular changes on OCT-A may occur before visible neurodegenerative changes on OCT, providing new insights into the course of the disease.
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http://dx.doi.org/10.1038/s41433-021-01699-4DOI Listing
July 2021

Diagnostic circulating biomarkers to detect vision-threatening diabetic retinopathy: Potential screening tool of the future?

Acta Ophthalmol 2021 Jul 16. Epub 2021 Jul 16.

Institute of Ophthalmology, University College London, London, UK.

With the increasing prevalence of diabetes in developing and developed countries, the socio-economic burden of diabetic retinopathy (DR), the leading complication of diabetes, is growing. Diabetic retinopathy (DR) is currently one of the leading causes of blindness in working-age adults worldwide. Robust methodologies exist to detect and monitor DR; however, these rely on specialist imaging techniques and qualified practitioners. This makes detecting and monitoring DR expensive and time-consuming, which is particularly problematic in developing countries where many patients will be remote and have little contact with specialist medical centres. Diabetic retinopathy (DR) is largely asymptomatic until late in the pathology. Therefore, early identification and stratification of vision-threatening DR (VTDR) is highly desirable and will ameliorate the global impact of this disease. A simple, reliable and more cost-effective test would greatly assist in decreasing the burden of DR around the world. Here, we evaluate and review data on circulating protein biomarkers, which have been verified in the context of DR. We also discuss the challenges and developments necessary to translate these promising data into clinically useful assays, to detect VTDR, and their potential integration into simple point-of-care testing devices.
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http://dx.doi.org/10.1111/aos.14954DOI Listing
July 2021

Evaluation of standard of care intravitreal aflibercept treatment of diabetic macular oedema treatment-naive patients in the UK: DRAKO study 12-month outcomes.

Eye (Lond) 2021 Jul 9. Epub 2021 Jul 9.

Bayer Plc, Reading, UK.

Objectives: DRAKO (NCT02850263) is a 24-month, prospective, non-interventional, multi-centre cohort study which enroled patients diagnosed with centre-involving diabetic macular oedema (DMO). The study aims to evaluate standard of care with intravitreal aflibercept (IVT-AFL) treatment in the UK. This analysis describes the anti-vascular endothelial growth factor (anti-VEGF) treatment-naive patient cohort after 12-month follow-up.

Methods: Study eyes were treated with IVT-AFL as per local standard of care. The mean change in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline at 12 months were measured and stratified by baseline factors. The number of injections and safety data were also evaluated.

Results: A total of 507 patients were enroled from 35 centres. Mean (SD) baseline BCVA was 71.4 (12.0) letters and CST was 448.7 (88.7) µm, with 63.1% of patients presenting with baseline BCVA ≥ 70 letters (mean 78.1). Mean (SD) change in BCVA of 2.5 (12.2) letters and CST of -119.1 (116.4) µm was observed at month 12. A 7.3 letter gain was observed in patients with baseline BCVA < 70 letters. Mean number (SD) of injections in year one was 6.4 (2.1). No significant adverse events were recorded.

Conclusion: Year one results indicated that IVT-AFL was an effective treatment for DMO in standard of care UK clinical practice, maintaining or improving visual acuity in treatment-naive patients with good baseline visual acuity, despite some patients being undertreated versus the summary of product characteristics. These results also demonstrated the clinical importance and meaningful impact of diabetic retinopathy screening in the UK.
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http://dx.doi.org/10.1038/s41433-021-01624-9DOI Listing
July 2021

Development and validation of resource-driven risk prediction models for incident chronic kidney disease in type 2 diabetes.

Sci Rep 2021 Jul 1;11(1):13654. Epub 2021 Jul 1.

NIHR Moorfields Biomedical Research Centre, University College London, City Road, London, 162EC1V 2PD, UK.

Prediction models for population-based screening need, for global usage, to be resource-driven, involving predictors that are affordably resourced. Here, we report the development and validation of three resource-driven risk models to identify people with type 2 diabetes (T2DM) at risk of stage 3 CKD defined by a decline in estimated glomerular filtration rate (eGFR) to below 60 mL/min/1.73m. The observational study cohort used for model development consisted of data from a primary care dataset of 20,510 multi-ethnic individuals with T2DM from London, UK (2007-2018). Discrimination and calibration of the resulting prediction models developed using cox regression were assessed using the c-statistic and calibration slope, respectively. Models were internally validated using tenfold cross-validation and externally validated on 13,346 primary care individuals from Wales, UK. The simplest model was simplified into a risk score to enable implementation in community-based medicine. The derived full model included demographic, laboratory parameters, medication-use, cardiovascular disease history (CVD) and sight threatening retinopathy status (STDR). Two less resource-intense models were developed by excluding CVD and STDR in the second model and HbA1c and HDL in the third model. All three 5-year risk models had good internal discrimination and calibration (optimism adjusted C-statistics were each 0.85 and calibration slopes 0.999-1.002). In Wales, models achieved excellent discrimination(c-statistics ranged 0.82-0.83). Calibration slopes at 5-years suggested models over-predicted risks, however were successfully updated to accommodate reduced incidence of stage 3 CKD in Wales, which improved their alignment with the observed rates in Wales (E/O ratios near to 1). The risk score demonstrated similar model performance compared to direct evaluation of the cox model. These resource-driven risk prediction models may enable universal screening for Stage 3 CKD to enable targeted early optimisation of risk factors for CKD.
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http://dx.doi.org/10.1038/s41598-021-93096-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8249456PMC
July 2021

Complex interventions to implement a diabetic retinopathy care pathway in the public health system in Kerala: the Nayanamritham study protocol.

BMJ Open 2021 06 28;11(6):e040577. Epub 2021 Jun 28.

Ophthalmology Department, Regional Institute of Ophthalmology, Government Medical College, Thiruvananthapuram, India.

Introduction: Using a type 2 hybrid effectiveness-implementation design, we aim to pilot a diabetic retinopathy (DR) care pathway in the public health system in Kerala to understand how it can be scaled up to and sustained in the whole state.

Methods And Analysis: Currently, there is no systematic DR screening programme in Kerala. Our intervention is a teleophthalmology pathway for people with diabetes in the non-communicable disease registers in 16 family health centres. The planned implementation strategy of the pathway will be developed based on the discrete Expert Recommendations for Implementing Change taxonomy. We will use both quantitative data from a cross-sectional study and qualitative data obtained from structured interviews, surveys and group discussions with stakeholders to report the effectiveness of the DR care pathway and evaluation of the implementation strategy.We will use logistic regression models to assess crude associations DR and sight-threatening diabetic retinopathy and fractional polynomials to account for the form of continuous covariates to predict uptake of DR screening. The primary effectiveness outcome is the proportion of patients in the non-communicable disease register with diabetes screened for DR over 12 months. Other outcomes include cost-effectiveness, safety, efficiency, patient satisfaction, timeliness and equity. The outcomes of evaluation of the implementation strategies include acceptability, feasibility, adoption, appropriateness, fidelity, penetration, costs and sustainability. Addition of more family health centres during the staggered initial phase of the programme will be considered as a sign of acceptability and feasibility. In the long term, the state-wide adoption of the DR care pathway will be considered as a successful outcome of the Nayanamritham study.

Ethics And Dissemination: The study was approved by Indian Medical Research Council (2018-0551) dated 13 March 2019. Study findings will be disseminated through scientific publications and the report will inform adoption of the DR care pathway by Kerala state in future.

Trial Registration Number: ISRCTN28942696.
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http://dx.doi.org/10.1136/bmjopen-2020-040577DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8240569PMC
June 2021

Prevalence and incidence of diabetic retinopathy (DR) in the UK population of Gloucestershire.

Acta Ophthalmol 2021 Jun 28. Epub 2021 Jun 28.

Boehringer Ingelheim International GmBH, Ingelheim, Germany.

Purpose: To estimate prevalence and incidence of diabetic retinopathy (DR) in a UK region by severity between 2012 and 2016 and risk factors for progression to proliferative DR (PDR).

Methods: Electronic medical records from people with diabetes (PWD) ≥18 years seen at the Gloucestershire Diabetic Eye Screening Programme (GDESP) and the hospital eye clinic were analysed (HEC). Prevalence and incidence of DR per 100 PWD (%) by calendar year, grade and diabetes type were estimated using log-linear regression. Progression to PDR and associated risk factors were estimated using parametric survival analyses.

Results: Across the study period, 35 873 PWD had at least one DR assessment. They were aged 66 (56-75) years (median (interquartile range)), 57% male, 5 (1-10) years since diabetes diagnosis, 93% Type 2 diabetes. Prevalence of DR decreased from 38.9% (95% CI: 38.1%, 39.8%) in 2012 to 36.6% (95% CI: 35.9%, 37.3%) in 2016 (p < 0.001). Incidence of any DR decreased from 10.9% (95% CI: 10.4%, 11.5%) in 2013 to 8.5% (95% CI: 8.1%, 9.0%) in 2016 (p < 0.001). Prevalence of PDR decreased from 3.5% (95% CI: 3.3%, 3.8%) in 2012 to 3.1% (95% CI 2.9%, 3.3%) in 2016 (p = 0.008). Incidence of PDR did not change over time. HbA and bilateral moderate-severe NPDR were statistically significant risk factors associated with progression to PDR.

Conclusions: Incidence and prevalence of DR decreased between 2012 and 2016 in this well-characterized population of the UK.
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http://dx.doi.org/10.1111/aos.14927DOI Listing
June 2021

Is immediate treatment necessary for diabetic macular edema after pars plana vitrectomy for tractional complications of proliferative diabetic retinopathy?

Int Ophthalmol 2021 Jun 25. Epub 2021 Jun 25.

Retina Vitreous Service, L V Prasad Eye Institute, Vishakhapatnam, India.

Purpose: To assess the treatment benefit of eyes with diabetic macular edema (DME) in vitrectomized eyes for tractional complications of proliferative diabetic retinopathy (PDR).

Methods: In a retrospective multicentre observational study in India, the clinical outcomes of eyes with center-involving DME in vitrectomized eyes for tractional complications of PDR in people with type 2 diabetes with at least 12 months follow-up data were assessed. The DME status and visual acuity outcomes were compared between those who received treatment versus those observed.

Results: In the 10-year study period, 45 eyes of 44 patients from 5 tertiary centers in India met the inclusion criteria. Center-involving DME was documented after a mean of 7 ± 7 months following pars plan vitrectomy (PPV) for tractional complications of PDR. More than half of the (n = 25) eyes were immediately treated for DME, and treatment was deferred for the rest. At one year, there was a statistically significant reduction in mean central subfield thickness in treated (467.9 ± 124.8 μm to 367.8 ± 143.7 μm; p < 0.001) as well as observed (405.2 ± 132.6 μm to 325.6 ± 149 μm; p < 0.001) eyes, and the change was comparable (p = 0.574). The change in vision was also comparable (0.12 ± 0.31 and 0.22 ± 0.54 Log MAR in the treated and observed group, respectively; p = 0.443).

Conclusion: Treatment for pre-existing or new-onset DME after PPV for tractional complications of PDR may be deferred for up to one year because the DME may resolve spontaneously with time.
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http://dx.doi.org/10.1007/s10792-021-01923-wDOI Listing
June 2021

Prevalence and phenotype associations of complement factor I mutations in geographic atrophy.

Hum Mutat 2021 Sep 29;42(9):1139-1152. Epub 2021 Jun 29.

Division of Clinical Neurosciences, Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.

Rare variants in the complement factor I (CFI) gene, associated with low serum factor I (FI) levels, are strong risk factors for developing the advanced stages of age-related macular degeneration (AMD). No studies have been undertaken on the prevalence of disease-causing CFI mutations in patients with geographic atrophy (GA) secondary to AMD. A multicenter, cross-sectional, noninterventional study was undertaken to identify the prevalence of pathogenic rare CFI gene variants in an unselected cohort of patients with GA and low FI levels. A genotype-phenotype study was performed. Four hundred and sixty-eight patients with GA secondary to AMD were recruited to the study, and 19.4% (n = 91) demonstrated a low serum FI concentration (below 15.6 μg/ml). CFI gene sequencing on these patients resulted in the detection of rare CFI variants in 4.7% (n = 22) of recruited patients. The prevalence of CFI variants in patients with low serum FI levels and GA was 25%. Of the total patients recruited, 3.2% (n = 15) expressed a CFI variant classified as pathogenic or likely pathogenic. The presence of reticular pseudodrusen was detected in all patients with pathogenic CFI gene variants. Patients with pathogenic CFI gene variants and low serum FI levels might be suitable for FI supplementation in therapeutic trials.
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http://dx.doi.org/10.1002/humu.24242DOI Listing
September 2021

Intravitreal ranibizumab versus aflibercept versus bevacizumab for macular oedema due to central retinal vein occlusion: the LEAVO non-inferiority three-arm RCT.

Health Technol Assess 2021 Jun;25(38):1-196

School of Health and Related Research, University of Sheffield, Sheffield, UK.

Background: Licensed ranibizumab (0.5 mg/0.05 ml Lucentis; Novartis International AG, Basel, Switzerland) and aflibercept (2 mg/0.05 ml Eylea; Bayer AG, Leverkusen, Germany) and unlicensed bevacizumab (1.25 mg/0.05 ml Avastin; F. Hoffmann-La Roche AG, Basel, Switzerland) are used to treat macula oedema due to central retinal vein occlusion, but their relative clinical effectiveness, cost-effectiveness and impact on the UK NHS and Personal Social Services have never been directly compared over the typical disease treatment period.

Objective: The objective was to compare the clinical effectiveness and cost-effectiveness of three intravitreal antivascular endothelial growth factor agents for the management of macula oedema due to central retinal vein occlusion.

Design: This was a three-arm, double-masked, randomised controlled non-inferiority trial.

Setting: The trial was set in 44 UK NHS ophthalmology departments, between 2014 and 2018.

Participants: A total of 463 patients with visual impairment due to macula oedema secondary to central retinal vein occlusion were included in the trial.

Interventions: The participants were treated with repeated intravitreal injections of ranibizumab ( = 155), aflibercept ( = 154) or bevacizumab ( = 154).

Main Outcome Measures: The primary outcome was an increase in the best corrected visual acuity letter score from baseline to 100 weeks in the trial eye. The null hypothesis that aflibercept and bevacizumab are each inferior to ranibizumab was tested with a non-inferiority margin of -5 visual acuity letters over 100 weeks. Secondary outcomes included additional visual acuity, and imaging outcomes, Visual Function Questionnaire-25, EuroQol-5 Dimensions with and without a vision bolt-on, and drug side effects. Cost-effectiveness was estimated using treatment costs and Visual Function Questionnaire-Utility Index to measure quality-adjusted life-years.

Results: The adjusted mean changes at 100 weeks in the best corrected visual acuity letter scores were as follows - ranibizumab, 12.5 letters (standard deviation 21.1 letters); aflibercept, 15.1 letters (standard deviation 18.7 letters); and bevacizumab, 9.8 letters (standard deviation 21.4 letters). Aflibercept was non-inferior to ranibizumab in the intention-to-treat population (adjusted mean best corrected visual acuity difference 2.23 letters, 95% confidence interval -2.17 to 6.63 letters;  = 0.0006), but not superior. The study was unable to demonstrate that bevacizumab was non-inferior to ranibizumab in the intention-to-treat population (adjusted mean best corrected visual acuity difference -1.73 letters, 95% confidence interval -6.12 to 2.67 letters;  = 0.071). A post hoc analysis was unable to demonstrate that bevacizumab was non-inferior to aflibercept in the intention-to-treat population (adjusted mean best corrected visual acuity difference was -3.96 letters, 95% confidence interval -8.34 to 0.42 letters;  = 0.32). All per-protocol population results were the same. Fewer injections were required with aflibercept (10.0) than with ranibizumab (11.8) (difference in means -1.8, 95% confidence interval -2.9 to -0.8). A post hoc analysis showed that more bevacizumab than aflibercept injections were required (difference in means 1.6, 95% confidence interval 0.5 to 2.7). There were no new safety concerns. The model- and trial-based cost-effectiveness analyses estimated that bevacizumab was the most cost-effective treatment at a threshold of £20,000-30,000 per quality-adjusted life-year.

Limitations: The comparison of aflibercept and bevacizumab was a post hoc analysis.

Conclusion: The study showed aflibercept to be non-inferior to ranibizumab. However, the possibility that bevacizumab is worse than ranibizumab and aflibercept by 5 visual acuity letters cannot be ruled out. Bevacizumab is an economically attractive treatment alternative and would lead to substantial cost savings to the NHS and other health-care systems. However, uncertainty about its relative effectiveness should be discussed comprehensively with patients, their representatives and funders before treatment is considered.

Future Work: To obtain extensive patient feedback and discuss with all stakeholders future bevacizumab NHS use.

Trial Registration: Current Controlled Trials ISRCTN13623634.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 38. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25380DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8287375PMC
June 2021

Reply to: 'Current perspectives on the use of eplerenone for chronic central serous chorioretinopathy'.

Eye (Lond) 2021 Jun 4. Epub 2021 Jun 4.

Bristol Trials Centre, Clinical Trials and Evaluation Unit, University of Bristol, Bristol Royal Infirmary, Bristol, UK.

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http://dx.doi.org/10.1038/s41433-020-01327-7DOI Listing
June 2021

Galectins in the Pathogenesis of Common Retinal Disease.

Front Pharmacol 2021 17;12:687495. Epub 2021 May 17.

UCL Institute of Ophthalmology, University College London, London, United Kingdom.

Diseases of the retina are major causes of visual impairment and blindness in developed countries and, due to an ageing population, their prevalence is continually rising. The lack of effective therapies and the limitations of those currently in use highlight the importance of continued research into the pathogenesis of these diseases. Vascular endothelial growth factor (VEGF) plays a major role in driving vascular dysfunction in retinal disease and has therefore become a key therapeutic target. Recent evidence also points to a potentially similarly important role of galectins, a family of β-galactoside-binding proteins. Indeed, they have been implicated in regulating fundamental processes, including vascular hyperpermeability, angiogenesis, neuroinflammation, and oxidative stress, all of which also play a prominent role in retinopathies. Here, we review direct evidence for pathological roles of galectins in retinal disease. In addition, we extrapolate potential roles of galectins in the retina from evidence in cancer, immune and neuro-biology. We conclude that there is value in increasing understanding of galectin function in retinal biology, in particular in the context of the retinal vasculature and microglia. With greater insight, recent clinical developments of galectin-targeting drugs could potentially also be of benefit to the clinical management of many blinding diseases.
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http://dx.doi.org/10.3389/fphar.2021.687495DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8165321PMC
May 2021

Indicators of Visual Prognosis in Diabetic Macular Oedema.

J Pers Med 2021 May 22;11(6). Epub 2021 May 22.

NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital, 162, City Road, London EC1V 2PD, UK.

Diabetic macular oedema (DMO) is an important cause of moderate vision loss in people with diabetes. Advances in imaging technology have shown that a significant proportion of patients with DMO respond sub-optimally to existing treatment options. Identifying associations and predictors of response before treatment is initiated may help in explaining visual prognosis to patients and aid the development of personalized treatment strategies. Imaging features, such as central subfoveal thickness, photoreceptor integrity, disorganization of retinal inner layers, choroidal changes, and macular perfusion, have been reported to be prognostic factors of visual acuity (VA) in DMO. In this review we evaluated each risk factor to understand their relative importance in visual prognostication of DMO eyes post-treatment. Although individually, some of these factors may not be significant predictors, in combination they may form phenotypes that can inform visual prognosis. Stratification based on these phenotypes needs to be developed to progress to personalized medicine for DMO.
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http://dx.doi.org/10.3390/jpm11060449DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8224579PMC
May 2021

Multimodal imaging interpreted by graders to detect re-activation of diabetic eye disease in previously treated patients: the EMERALD diagnostic accuracy study.

Health Technol Assess 2021 May;25(32):1-104

Warwick Medical School, University of Warwick, Coventry, UK.

Background: Owing to the increasing prevalence of diabetes, the workload related to diabetic macular oedema and proliferative diabetic retinopathy is rising, making it difficult for hospital eye services to meet demands.

Objective: The objective was to evaluate the diagnostic performance, cost-effectiveness and acceptability of a new pathway using multimodal imaging interpreted by ophthalmic graders to detect reactivation of diabetic macular oedema/proliferative diabetic retinopathy in previously treated patients.

Design: This was a prospective, case-referent, cross-sectional diagnostic study.

Setting: The setting was ophthalmic clinics in 13 NHS hospitals.

Participants: Adults with type 1 or type 2 diabetes with previously successfully treated diabetic macular oedema/proliferative diabetic retinopathy in one/both eyes in whom, at the time of enrolment, diabetic macular oedema/proliferative diabetic retinopathy could be active or inactive.

Methods: For the ophthalmic grader pathway, review of the spectral domain optical coherence tomography scans to detect diabetic macular oedema, and seven-field Early Treatment Diabetic Retinopathy Study/ultra-wide field fundus images to detect proliferative diabetic retinopathy, by trained ophthalmic graders. For the current standard care pathway (reference standard), ophthalmologists examined patients face to face by slit-lamp biomicroscopy for proliferative diabetic retinopathy and, in addition, spectral domain optical coherence tomography imaging for diabetic macular oedema.

Outcome Measures: The primary outcome measure was sensitivity of the ophthalmic grader pathway to detect active diabetic macular oedema/proliferative diabetic retinopathy. The secondary outcomes were specificity, agreement between pathways, cost-consequences, acceptability and the proportion of patients requiring subsequent ophthalmologist assessment, unable to undergo imaging and with inadequate quality images/indeterminate findings. It was assumed for the main analysis that all patients in whom graders diagnosed active disease or were 'unsure' or images were 'ungradable' required examination by an ophthalmologist.

Results: Eligible participants with active and inactive diabetic macular oedema (152 and 120 participants, respectively) and active and inactive proliferative diabetic retinopathy (111 and 170 participants, respectively) were recruited. Under the main analysis, graders had a sensitivity of 97% (142/147) (95% confidence interval 92% to 99%) and specificity of 31% (35/113) (95% confidence interval 23% to 40%) to detect diabetic macular oedema. For proliferative diabetic retinopathy, graders had a similar sensitivity and specificity using seven-field Early Treatment Diabetic Retinopathy Study [sensitivity 85% (87/102), 95% confidence interval 77% to 91%; specificity 48% (77/160), 95% confidence interval 41% to 56%] or ultra-wide field imaging [sensitivity 83% (87/105), 95% confidence interval 75% to 89%; specificity 54% (86/160), 95% confidence interval 46% to 61%]. Participants attending focus groups expressed preference for face-to-face evaluations by ophthalmologists. In the ophthalmologists' absence, patients voiced the need for immediate feedback following grader's assessments, maintaining periodic evaluations by ophthalmologists. Graders and ophthalmologists were supportive of the new pathway. When compared with the reference standard (current standard pathway), the new grader pathway could save £1390 per 100 patients in the review of people with diabetic macular oedema and, depending on the imaging modality used, between £461 and £1189 per 100 patients in the review of people with proliferative diabetic retinopathy.

Conclusions: For people with diabetic macular oedema, the ophthalmic grader pathway appears safe and cost saving. The sensitivity of the new pathway to detect active proliferative diabetic retinopathy was lower, but may still be considered acceptable for patients with proliferative diabetic retinopathy previously treated with laser. Suggestions from focus group discussions should be taken into consideration if the new pathway is introduced to ensure its acceptability to users.

Limitations: Lack of fundus fluorescein angiography to confirm diagnosis of active proliferative diabetic retinopathy.

Future Work: Could refinement of the new pathway increase its sensitivity to detect proliferative diabetic retinopathy? Could artificial intelligence be used for automated reading of images in this previously treated population?

Trial Registration: Current Controlled Trials ISRCTN10856638 and ClinicalTrials.gov NCT03490318.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Vol. 25, No. 32. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25320DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8200933PMC
May 2021

Response to 'Comment on 'Drusen and pachydrusen: the definition, pathogenesis and clinical significance''.

Eye (Lond) 2021 May 27. Epub 2021 May 27.

NIHR Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, UK.

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http://dx.doi.org/10.1038/s41433-021-01577-zDOI Listing
May 2021

The clinical relevance of ultra-widefield angiography findings in patients with central retinal vein occlusion and macular oedema receiving anti-VEGF therapy.

Eye (Lond) 2021 May 25. Epub 2021 May 25.

National Institute for Health Research, Moorfields Biomedical Research Centre, London, UK.

Aims: To report, using ultra-widefield angiography (UWFA) the area, distribution, and change in retinal capillary nonperfusion (RCNP) at baseline and 100 weeks in eyes with central retinal vein occlusion (CRVO) receiving anti-VEGF for macula oedema.

Methods: Prospective longitudinal multi-centre cohort study. Adults with CRVO treated with anti-VEGF therapy for macular oedema underwent UWFA at baseline and week-100. The area, distribution, and change in total, peripheral and posterior pole RCNP were determined.

Results: Of 153 eyes at baseline, mean area of RCNP was 34.3DA and 12 (7.8%) had ≥75DA RCNP. More than 10DA RCNP was present in the temporal periphery in 75.8% of eyes vs. 10.5% in the nasal periphery. At week-100, mean RCNP was 42.1DA with a median change from baseline of 3.3DA 95% CI [0.4, 7.3]; p < 0.01. Of 146 eyes with ≤10DA of posterior pole RCNP at baseline, 16/146 (11.0%) progressed to >10DA at week-100. These eyes had a median increase in total RCNP of 69.7DA [95% CI 27.2-85.4] vs 0DA [0.0-1.4]; p < 0.001 for those who did not, and two developed neovascular glaucoma. Larger baseline area of RCNP and history of glaucoma were risk factors for posterior pole RCNP developing.

Conclusions: With UWFA, significant baseline RCNP was identified in the majority of CRVO patients, notably in the temporal periphery, but large increases over 100 weeks were uncommon. Development of >10DA posterior pole RCNP is a marker for widespread RCNP and in such cases the risk of anterior segment neovascularisation is not abolished by concomitant anti-VEGF therapy.
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http://dx.doi.org/10.1038/s41433-021-01553-7DOI Listing
May 2021

Venous overload choroidopathy: A hypothetical framework for central serous chorioretinopathy and allied disorders.

Prog Retin Eye Res 2021 May 21:100973. Epub 2021 May 21.

Institute of Molecular and Clinical Ophthalmology Basel, Basel, Switzerland. Electronic address:

In central serous chorioretinopathy (CSC), the macula is detached because of fluid leakage at the level of the retinal pigment epithelium. The fluid appears to originate from choroidal vascular hyperpermeability, but the etiology for the fluid is controversial. The choroidal vascular findings as elucidated by recent optical coherence tomography (OCT) and wide-field indocyanine green (ICG) angiographic evaluation show eyes with CSC have many of the same venous patterns that are found in eyes following occlusion of the vortex veins or carotid cavernous sinus fistulas (CCSF). The eyes show delayed choroidal filling, dilated veins, intervortex venous anastomoses, and choroidal vascular hyperpermeability. While patients with occlusion of the vortex veins or CCSF have extraocular abnormalities accounting for the venous outflow problems, eyes with CSC appear to have venous outflow abnormalities as an intrinsic phenomenon. Control of venous outflow from the eye involves a Starling resistor effect, which appears to be abnormal in CSC. Similar choroidal vascular abnormalities have been found in peripapillary pachychoroid syndrome. However, peripapillary pachychoroid syndrome has intervortex venous anastomoses located in the peripapillary region while in CSC these are seen to be located in the macular region. Spaceflight associated neuro-ocular syndrome appears to share many of the pathophysiologic problems of abnormal venous outflow from the choroid along with a host of associated abnormalities. These diseases vary according to their underlying etiologies but are linked by the venous decompensation in the choroid that leads to significant vision loss. Choroidal venous overload provides a unifying concept and theory for an improved understanding of the pathophysiology and classification of a group of diseases to a greater extent than previous proposals.
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http://dx.doi.org/10.1016/j.preteyeres.2021.100973DOI Listing
May 2021

Scotopic thresholds on dark-adapted chromatic perimetry in healthy aging and age-related macular degeneration.

Sci Rep 2021 May 14;11(1):10349. Epub 2021 May 14.

Institute of Ophthalmology, University College London, London, EC1V 9EL, UK.

To evaluate the effect of aging, intra- and intersession repeatability and regional scotopic sensitivities in healthy and age-related macular degeneration (AMD) eyes. Intra- and intersession agreement and effect of age was measured in healthy individuals. The mean sensitivity (MS) and pointwise retinal sensitivities (PWS) within the central 24° with 505 nm (cyan) and 625 nm (red) stimuli were evaluated in 50 individuals (11 healthy and 39 AMD eyes). The overall intra- and intersession had excellent reliability (intraclass correlation coefficient, ICC > 0.90) and tests were highly correlated (Spearman r = 0.75-0.86). Eyes with subretinal drusenoid deposit (SDD) had reduced PWS centrally, particularly at inferior and nasal retinal locations compared with controls and intermediate AMD (iAMD) without SDD. There was no difference in MS or PWS at any retinal location between iAMD without SDD and healthy individuals nor between iAMD with SDD and non-foveal atrophic AMD groups. Eyes with SDD have reduced rod function compared to iAMD without SDD and healthy eyes, but similar to eyes with non-foveal atrophy. Our results highlight rod dysfunction is not directly correlated with drusen load and SDD location.
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http://dx.doi.org/10.1038/s41598-021-89677-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8121851PMC
May 2021

Recently updated global diabetic retinopathy screening guidelines: commonalities, differences, and future possibilities.

Eye (Lond) 2021 Oct 11;35(10):2685-2698. Epub 2021 May 11.

Department of Research, Ophthalmic epidemiology & Low Vision, King Khalid Eye Hospital, Riyadh, Kingdom of Saudi Arabia.

Diabetic retinopathy (DR) is a global health burden. Screening for sight-threatening DR (STDR) is the first cost-effective step to decrease this burden. We analyzed the similarities and variations between the recent country-specific and the International Council of Ophthalmology (ICO) DR guideline to identify gaps and suggest possible solutions for future universal screening. We selected six representative national DR guidelines, one from each World Health Organization region, including Canada (North America), England (Europe), India (South- East Asia), Kenya (Africa), New Zealand (Western Pacific), and American Academy of Ophthalmology Preferred Practice Pattern (used in Latin America and East Mediterranean). We weighed the newer camera and artificial intelligence (AI) technology against the traditional screening methodologies. All guidelines agree that screening for DR and STDR in people with diabetes is currently led by an ophthalmologist; few engage non-ophthalmologists. Significant variations exist in the screening location and referral timelines. Screening with digital fundus photography has largely replaced traditional slit-lamp examination and ophthalmoscopy. The use of mydriatic digital 2-or 4-field fundus photography is the current norm; there is increasing interest in using non-mydriatic fundus cameras. The use of automated DR grading and tele-screening is currently sparse. Country-specific guidelines are necessary to align with national priorities and human resources. International guidelines such as the ICO DR guidelines remain useful in countries where no guidelines exist. Validation studies on AI and tele-screening call for urgent policy decisions to integrate DR screening into universal health coverage to reduce this global public health burden.
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http://dx.doi.org/10.1038/s41433-021-01572-4DOI Listing
October 2021

Deep learning for gradability classification of handheld, non-mydriatic retinal images.

Sci Rep 2021 05 4;11(1):9469. Epub 2021 May 4.

Institute of Ophthalmology, University College London, London, EC1V 9EL, UK.

Screening effectively identifies patients at risk of sight-threatening diabetic retinopathy (STDR) when retinal images are captured through dilated pupils. Pharmacological mydriasis is not logistically feasible in non-clinical, community DR screening, where acquiring gradable retinal images using handheld devices exhibits high technical failure rates, reducing STDR detection. Deep learning (DL) based gradability predictions at acquisition could prompt device operators to recapture insufficient quality images, increasing gradable image proportions and consequently STDR detection. Non-mydriatic retinal images were captured as part of SMART India, a cross-sectional, multi-site, community-based, house-to-house DR screening study between August 2018 and December 2019 using the Zeiss Visuscout 100 handheld camera. From 18,277 patient eyes (40,126 images), 16,170 patient eyes (35,319 images) were eligible and 3261 retinal images (1490 patient eyes) were sampled then labelled by two ophthalmologists. Compact DL model area under the receiver operator characteristic curve was 0.93 (0.01) following five-fold cross-validation. Compact DL model agreement (Kappa) were 0.58, 0.69 and 0.69 for high specificity, balanced sensitivity/specificity and high sensitivity operating points compared to an inter-grader agreement of 0.59. Compact DL gradability model performance was favourable compared to ophthalmologists. Compact DL models can effectively classify non-mydriatic, handheld retinal image gradability with potential applications within community-based DR screening.
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http://dx.doi.org/10.1038/s41598-021-89027-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8096843PMC
May 2021

Recurring themes during cataract assessment and surgery.

Eye (Lond) 2021 09 29;35(9):2482-2498. Epub 2021 Apr 29.

Sussex Eye Hospital, Brighton & Sussex University Hospitals NHS Trust, Brighton, UK.

The aim of this review was to discuss frequently encountered themes such as cataract surgery in presence of age-related macular degeneration (AMD), dementia, Immediate Sequential Bilateral Cataract Surgery (ISBCS), discussing non-standard intraocular lens (IOL) options during consultation in the National Health Services (NHS) and the choice of the biometric formulae based on axial length. Individual groups of authors worked independently on each topic. We found that cataract surgery does improve visual acuity in AMD patients but the need for cataract surgery should be individualised. In patients with dementia, cataract surgery should be considered 'sooner rather than later' as progression may prevent individuals presenting for surgery. This should be planned after discussion of patients' best interests with any carers; multifocal IOLs are not proven to be the best option in these patients. ISBCS gives comparable outcomes to delayed sequential surgeries with a low risk of bilateral endophthalmitis and it can be cost-saving and efficient. Patients are entitled to know all suitable IOL options that can improve their quality of life. Deliberately withholding this information or pressuring patients to choose a non-standard IOL is inappropriate. However, one should be mindful of the not spending inappropriate amounts of time discussing these in the NHS setting which may affect care of other NHS patients. Evidence suggests Hoffer Q, Haigis, Hill-RBF and Kane formulae for shorter eyes; Barrett Universal II (BU II), Holladay II, Haigis and Kane formulae for longer eyes and BU II, Hill-RBF and Kane formulae for medium axial length eyes.
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http://dx.doi.org/10.1038/s41433-021-01548-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8376990PMC
September 2021

Cost Effectiveness of Ranibizumab vs Aflibercept vs Bevacizumab for the Treatment of Macular Oedema Due to Central Retinal Vein Occlusion: The LEAVO Study.

Pharmacoeconomics 2021 Aug 26;39(8):913-927. Epub 2021 Apr 26.

School of Health and Related Research, University of Sheffield, Sheffield, UK.

Background: We aimed to assess the cost effectiveness of intravitreal ranibizumab (Lucentis), aflibercept (Eylea) and bevacizumab (Avastin) for the treatment of macular oedema due to central retinal vein occlusion.

Methods: We calculated costs and quality-adjusted life-years from the UK National Health Service and Personal Social Services perspective. We performed a within-trial analysis using the efficacy, safety, resource use and health utility data from a randomised controlled trial (LEAVO) over 100 weeks. We built a discrete event simulation to model long-term outcomes. We estimated utilities using the Visual-Functioning Questionnaire-Utility Index, EQ-5D and EQ-5D with an additional vision question. We used standard UK costs sources for 2018/19 and a cost of £28 per bevacizumab injection. We discounted costs and quality-adjusted life-years at 3.5% annually.

Results: Bevacizumab was the least costly intervention followed by ranibizumab and aflibercept in both the within-trial analysis (bevacizumab: £6292, ranibizumab: £13,014, aflibercept: £14,328) and long-term model (bevacizumab: £18,353, ranibizumab: £30,226, aflibercept: £35,026). Although LEAVO did not demonstrate bevacizumab to be non-inferior for the visual acuity primary outcome, the three interventions generated similar quality-adjusted life-years in both analyses. Bevacizumab was always the most cost-effective intervention at a threshold of £30,000 per quality-adjusted life-year, even using the list price of £243 per injection.

Conclusions: Wider adoption of bevacizumab for the treatment of macular oedema due to central retinal vein occlusion could result in substantial savings to healthcare systems and deliver similar health-related quality of life. However, patients, funders and ophthalmologists should be fully aware that LEAVO could not demonstrate that bevacizumab is non-inferior to the licensed agents.
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http://dx.doi.org/10.1007/s40273-021-01026-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8298346PMC
August 2021
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