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The scanning CONfoCal Ophthalmoscopy foR DIAbetic eye screening (CONCORDIA) study paper 2.
PURPOSE: To determine if the Eidon white light 60-degree field Scanning Confocal Ophthalmoscope (SCO) camera was safe to use with staged mydriasis in a Diabetic Eye Screening Programme (DESP). METHODS: The trial participants were recruited from people with diabetes attending appointments in DESP or Virtual Eye clinics for post-Covid delayed hospital appointments. Using staged mydriasis, the SCO images were taken before the pupils were dilated and compared to two-field 45 degrees mydriatic digital photography (the reference standard). Mydriatic SCO images were only compared to the reference standard if the non-mydriatic SCO images were unassessable. RESULTS: 1050 patients were recruited, 35 individuals were withdrawn, the majority (18) due to an imaging protocol deviation leaving 1015 individuals (2029 eyes). Using staged mydriasis, the sensitivity and specificity for any retinopathy was 97.5% (95% CI: 96.4-98.4%) and 82.3% (95% CI: 79.6-84.7%) respectively. The sensitivity and specificity for referable retinopathy was 92.7% (95% CI: 89.9-94.9%) and 85.4% (95% CI: 83.6-87.2%) respectively. The total number of eyes that were unassessable with the Eidon without mydriasis was 85/2029 (4.2%), and after mydriasis was 34/2029 (1.7%) and, with the reference standard, 34/2029 (1.7% - not always the same images) were unassessable. CONCLUSIONS: This study provides promising early results of the performance of the Eidon camera using staged mydriasis in a DESP which needs further evidence from a non-Caucasian population and from cost-effectiveness analyses.
The Scanning CONfoCal Ophthalmoscopy foR DIAbetic eye screening (CONCORDIA) study paper 1.
OBJECTIVE: This project was to determine the performance of the Zeiss Clarus 700 (Clarus) and the Optos California (Optos) with staged mydriasis in a Diabetic Eye Screening Programme (DESP). METHODS: Trial participants were recruited from people attending appointments in DESP or Virtual Eye clinics for delayed hospital appointments. Non-mydriatic photographs from the Clarus and Optos cameras were compared to 2-field 45 degrees mydriatic digital photography (the reference standard) and mydriatic photographs compared if the non-mydriatic photos were unassessable (staged mydriasis). RESULTS: 1573 patients were recruited. 76 individuals were withdrawn, leaving 1497 individuals (2993 eyes). For the Clarus and the Optos, the sensitivity for any retinopathy were 94.2% (95% CI: 92.9-95.3%) and 91.9% (95% CI: 90.5-93.2%) with specificities of 87.3% (95% CI: 85.4-89.0%) and 78.1% (95% CI: 75.7-80.3%) respectively. For referable DR the sensitivities for the Clarus and Optos were 86.0% (95% CI: 82.9-88.8%) and 77.6% (95% CI: 73.9-80.9%) with specificities of 92.8% (95% CI: 91.7-93.8%) and 95.4% (95% CI: 94.5-96.2%) respectively. The Clarus and Optos without mydriasis produced 100 (3.3%) and 152 (5.1%) unassessable eyes respectively, and after staged mydriasis 51 (1.7%) and 102 (3.4%) respectively with 52 (1.7%) reference standard images unassessable. CONCLUSIONS: This study reports the performance of the Clarus and the Optos using staged mydriasis in DR screening with wider fields detecting more referable retinopathy peripherally with some reduction in sensitivity centrally for macular lesions.
Tele-Ophthalmology for Diabetic Retinopathy in the UK
Aim: of the English NHS Diabetic Eye Screening Programme (DESP) is to reduce the risk of sight loss among people with diabetes. Methodology: 2-field mydriatic digital photography. Benefits: Reduction in Vision Impairment and Blindness. Current developments: The English NHS DESP will be introducing extension of the screening interval in low-risk groups and digital surveillance clinics with OCT as a second line of screening for those with screen positive mac- ulopathy at primary screening. Further Developments: The NHS DESP is currently evaluating the safe and cost-effective use of Artificial Intelligence as a primary grading tool and newer camera technologies.
Surveillance of people with previously successfully treated diabetic macular oedema and proliferative diabetic retinopathy by trained ophthalmic graders: cost analysis from the EMERALD study.
BACKGROUND/AIMS: Surveillance of people with previously successfully treated diabetic macular oedema (DMO) and proliferative diabetic retinopathy (PDR) adds pressure on ophthalmology services. This study evaluated a new surveillance pathway entailing multimodal imaging reviewed by trained ophthalmic graders and compared it with the current standard care (face-to-face evaluation by an ophthalmologist). METHODS: Cost analysis of the new ophthalmic grader pathway, compared with the standard of care, from the perspective of the UK National Health Service, based on evidence from the Effectiveness of Multimodal imaging for the Evaluation of Retinal oedema And new vesseLs in Diabetic retinopathy study. Resource use data were prospectively obtained including times to undertake each procedure. Effectiveness was assessed in terms of sensitivity and specificity of referral decisions in the grader pathway. Costs (SDs) were analysed per 100 patients separately for DMO and PDR at 2018/2019 costs. RESULTS: For DMO, where sensitivity was very high (97%), the cost difference (savings) for the grader's pathway would be £1390 per 100 patients. For PDR, the cost would be reduced by £461 for seven-field Early Treatment for Diabetic Retinopathy Study (ETDRS) images and by £1889 for ultrawide field images, per 100 patients. Ultrawide images required less time to be obtained and read than seven-field ETDRS. The real savings would be in ophthalmologist time, which could be then redirected to the evaluation of people at high risk of visual loss. CONCLUSIONS: Surveillance of people with previously successfully treated DMO and PDR by trained ophthalmic graders can achieve satisfactory results and release ophthalmologist time. TRIAL REGISTRATION NUMBERS: NCT03490318, ISRCTN10856638.
Clinical efficacy and safety of a light mask for prevention of dark adaptation in treating and preventing progression of early diabetic macular oedema at 24 months (CLEOPATRA): a multicentre, phase 3, randomised controlled trial.
BACKGROUND: We aimed to assess 24-month outcomes of wearing an organic light-emitting sleep mask as an intervention to treat and prevent progression of non-central diabetic macular oedema. METHODS: CLEOPATRA was a phase 3, single-blind, parallel-group, randomised controlled trial undertaken at 15 ophthalmic centres in the UK. Adults with non-centre-involving diabetic macular oedema were randomly assigned (1:1) to wearing either a light mask during sleep (Noctura 400 Sleep Mask, PolyPhotonix Medical, Sedgefield, UK) or a sham (non-light) mask, for 24 months. Randomisation was by minimisation generated by a central web-based computer system. Outcome assessors were masked technicians and optometrists. The primary outcome was the change in maximum retinal thickness on optical coherence tomography (OCT) at 24 months, analysed using a linear mixed-effects model incorporating 4-monthly measurements and baseline adjustment. Analysis was done using the intention-to-treat principle in all randomised patients with OCT data. Safety was assessed in all patients. This trial is registered with Controlled-Trials.com, number ISRCTN85596558. FINDINGS: Between April 10, 2014, and June 15, 2015, 308 patients were randomly assigned to wearing the light mask (n=155) or a sham mask (n=153). 277 patients (144 assigned the light mask and 133 the sham mask) contributed to the mixed-effects model over time, including 246 patients with OCT data at 24 months. The change in maximum retinal thickness at 24 months did not differ between treatment groups (mean change -9·2 μm [SE 2·5] for the light mask vs -12·9 μm [SE 2·9] for the sham mask; adjusted mean difference -0·65 μm, 95% CI -6·90 to 5·59; p=0·84). Median compliance with wearing the light mask at 24 months was 19·5% (IQR 1·9-51·6). No serious adverse events were related to either mask. The most frequent adverse events related to the assigned treatment were discomfort on the eyes (14 with the light mask vs seven with the sham mask), painful, sticky, or watery eyes (14 vs six), and sleep disturbance (seven vs one). INTERPRETATION: The light mask as used in this study did not confer long-term therapeutic benefit on non-centre-involving diabetic macular oedema and the study does not support its use for this indication. FUNDING: The Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.