Evaluating Primary Treatment for People with Advanced Glaucoma: Five-Year Results of the Treatment of Advanced Glaucoma Study.

PURPOSE: To determine whether primary trabeculectomy or medical treatment produces better outcomes in terms of quality of life (QoL), clinical effectiveness, and safety in patients with advanced glaucoma. DESIGN: Multicenter randomized controlled trial. PARTICIPANTS: Between June 3, 2014, and May 31, 2017, 453 adults with newly diagnosed advanced open-angle glaucoma in at least 1 eye (Hodapp classification) were recruited from 27 secondary care glaucoma departments in the United Kingdom. Two hundred twenty-seven were allocated to trabeculectomy, and 226 were allocated medical management. METHODS: Participants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)-reducing drops as the primary intervention and were followed up for 5 years. MAIN OUTCOME MEASURES: The primary outcome was vision-specific QoL measured with the 25-item Visual Function Questionnaire (VFQ-25) at 5 years. Secondary outcomes were general health status, glaucoma-related QoL, clinical effectiveness (IOP, visual field, and visual acuity), and safety. RESULTS: At 5 years, the mean ± standard deviation VFQ-25 scores in the trabeculectomy and medication arms were 83.3 ± 15.5 and 81.3 ± 17.5, respectively, and the mean difference was 1.01 (95% confidence interval [CI], -1.99 to 4.00; P = 0.51). The mean IOPs were 12.07 ± 5.18 mmHg and 14.76 ± 4.14 mmHg, respectively, and the mean difference was -2.56 (95% CI, -3.80 to -1.32; P < 0.001). Glaucoma severity measured with visual field mean deviation were -14.30 ± 7.14 dB and -16.74 ± 6.78 dB, respectively, with a mean difference of 1.87 (95% CI, 0.87-2.87 dB; P < 0.001). Safety events occurred in 115 (52.2%) of patients in the trabeculectomy arm and 124 (57.9%) of patients in the medication arm (relative risk, 0.92; 95% CI, 0.72-1.19; P = 0.54). Serious adverse events were rare. CONCLUSIONS: At 5 years, the Treatment of Advanced Glaucoma Study demonstrated that primary trabeculectomy surgery is more effective in lowering IOP and preventing disease progression than primary medical treatment in patients with advanced disease and has a similar safety profile. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Surgeon effects on cataract refractive outcomes are minimal compared with patient comorbidity and gender: an analysis of 490 987 cases.

AIM: To investigate effect of patient age, gender, comorbidities and surgeon on refractive outcomes following cataract surgery. METHODS: Study population: patients on UK national ophthalmic cataract database on cataract operations undertaken between 1 April 2010 and 31 August 2018. Variables examined included gender, age, diabetic retinopathy, glaucoma, high myopia, inherited retinal disease, optic nerve disease, uveitis, pseudoexfoliation, vitreous opacities, retinal pathology, cataract type, previous surgery and posterior capsular rupture. A multivariate normal cross-classified model was fitted to the refractive outcome using Markov Chain Monte Carlo (MCMC) methods with diffuse priors to approximate maximum likelihood estimation. A MCMC chain was generated with a burn-in of 5000 iterations and a monitoring chain of 50 000 iterations. RESULTS: 490 987 cataract operations were performed on 351 864 patients by 2567 surgeons. Myopic and astigmatic errors were associated with posterior capsule rupture (-0.38/+0.04×72), glaucoma (-0.10/+0.05×95), previous vitrectomy (-0.049/+0.03×66) and high myopia (-0.07/+0.03×57). Hyperopic and astigmatic errors were associated with diabetic retinopathy (+0.08/+0.03×104), pseudoexfoliation (+0.07/+0.01×158), male gender (+0.12/+0.05×91) and age (-0.01/+0.06×97 per increasing decade). Inherited retinal disease, optic nerve disease, previous trabeculectomy, uveitis, brunescent/white cataract had no significant impact on the error of the refractive outcome. The effect of patient gender and comorbidity was additive. Surgeons only accounted for 4% of the unexplained variance in refractive outcome. CONCLUSION: Patient comorbidities and gender account for small but statistically significant differences in refractive outcome, which are additive. Surgeon effects are very small.

The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: Report 9, Risk factors for posterior capsule opacification.

BACKGROUND/OBJECTIVES: Posterior Capsule Opacification (PCO) is the most common long-term post-operative adverse occurrence after cataract surgery often requiring treatment with YAG laser posterior capsulotomy. This study aimed to identify potential risk factors, known at the time of cataract surgery, that influence the development of PCO. SUBJECT/METHODS: A retrospective study of publicly funded cataract surgery from The Royal College of Ophthalmologists' National Ophthalmology Database. Eligible for analysis were 500,872 cataract operations performed in 41 participating centres. RESULTS: The 500,872 operations were performed on 243,167 (48.5%) left eyes and 257,705 (51.5%) right eyes from 373,579 patients by 2196 surgeons. Post-cataract PCO was recorded for 61,778 (12.3%) eyes and the six month, one, three, five and nine year observed rates of PCO were 2.3%, 4.4%, 19.7%, 34.0% and 46.9% respectively. Different PCO profiles were observed between IOL materials and the identified risk factors that increased the risk of developing PCO included hydrophilic IOL material, axial length >26 mm, the presence of high myopia and implantation of lower IOL powers and previous vitrectomy surgery, along with younger age and female gender. CONCLUSIONS: Many factors influence the development of PCO relating to the patient, the eye, the lens and the surgery. Some factors are modifiable such as IOL material, therefore the opportunity exists to attempt to reduce PCO rates, benefitting patients and the UK NHS.

Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 8, cohort analysis of the relationship between intraoperative complications of cataract surgery and axial length.

OBJECTIVES: To describe the relationships between axial length and intraoperative complications in patients undergoing cataract surgery. DESIGN: Cohort analysis of the Royal College of Ophthalmologists' National Ophthalmology Database (RCOphth NOD). SETTING: 110 National Health Service Trusts in England, Health Boards in Wales, Independent Sector Treatment Centres and Guernsey. PARTICIPANTS: 820 354 patients, aged 18 years or older, undergoing cataract surgery. Eligible operations were those from centres with at least 50 operations with a recorded axial length measurement and age at surgery between 1 April 2010 and 31 August 2019. INTERVENTIONS: Phacoemulsification where the primary intention was cataract surgery alone. OUTCOME MEASURES: Posterior capsule rupture (PCR) and other recorded intraoperative complications. RESULTS: 1 211 520 eligible operations were performed by 3210 surgeons. The baseline axial length was <21 mm (short eyes) for 17 170 (1.4%) eyes, 21-28 mm (medium eyes) for 1 182 513 (97.6%) eyes and >28 mm (long eyes) for 11 837 (1.0%) eyes. The median age at surgery was younger for patients with long eyes than those with short or medium eyes. The rate of any intraoperative complication was higher for short eyes than medium or long with complication rates of 4.5%, 2.9% and 3.3%, respectively (p<0.001). PCR occurred in 1.40% surgeries overall, and in 1.53%, 1.40% and 1.61% of short, medium and long eyes, respectively (p=0.043, not significant at the 1% level). CONCLUSIONS: Overall PCR rates for cataract surgery in RCOphth NOD contributing centres are lower than previously reported and there is little change in PCR rates by axial length. Short eyes were more likely to have an intraoperative complication than medium or long eyes.

Cost-effectiveness of primary surgical versus primary medical management in the treatment of patients presenting with advanced glaucoma.

SYNOPSIS: Advanced glaucoma is associated with sight loss. This within-trial economic evaluation compares medical and surgical management strategies. At 2 years, medication appears more cost-effective though longitudinal outcomes are an important subject in future research. BACKGROUND/AIMS: Open angle glaucoma (OAG) is a progressive optic neuropathy. Approximately 25% of newly diagnosed patients with OAG present with advanced disease in at least one eye. The vision loss associated with OAG can lead to significant impacts on vision, quality of life and health care resources. The Treatment of Advanced Glaucoma Study is a randomised controlled trial comparing the effectiveness of primary surgical and medical management for newly diagnosed advanced patients with OAG. An economic evaluation was carried out to understand the costs and benefits of each strategy. METHODS: A cost utility analysis was carried out from a National Health Service perspective over a 2-year time horizon inclusive of patient costs. The primary outcome was patient health-related quality of life measured by the EQ-5D-5L, Health Utilities Index 3 (HUI3) and Glaucoma Utility Index (GUI). Results were expressed as incremental cost per QALY gained. RESULTS: Trabeculectomy was associated with higher costs and greater effect, the EQ-5D-5L results have an incremental cost per QALY of £45,456. The likelihood of surgery being cost-effective at a £20, 000, £30,000 and £50,000 QALY threshold is 0%, 12% and 56%, respectively. The results for the HUI3, GUI and inclusion of patient costs do not change the conclusions of the study. CONCLUSION: This is the first study to evaluate management strategies for those presenting with advanced glaucoma. At a 2-year time horizon, medication is the more cost-effective approach for managing glaucoma. Future research can focus on the costs and benefits of the treatments over a longer time horizon.

Primary trabeculectomy versus primary glaucoma eye drops for newly diagnosed advanced glaucoma: TAGS RCT.

BACKGROUND: Patients diagnosed with advanced primary open-angle glaucoma are at a high risk of lifetime blindness. Uncertainty exists about whether primary medical management (glaucoma eye drops) or primary surgical treatment (augmented trabeculectomy) provide the best and safest patient outcomes. OBJECTIVES: To compare primary medical management with primary surgical treatment (augmented trabeculectomy) in patients with primary open-angle glaucoma presenting with advanced disease in terms of health-related quality of life, clinical effectiveness, safety and cost-effectiveness. DESIGN: This was a two-arm, parallel, multicentre, pragmatic randomised controlled trial. SETTING: Secondary care eye services. PARTICIPANTS: Adult patients presenting with advanced primary open-angle glaucoma in at least one eye, as defined by the Hodapp-Parrish-Anderson classification of severe glaucoma. INTERVENTION: Primary medical treatment - escalating medical management with glaucoma eye drops. Primary trabeculectomy treatment - trabeculectomy augmented with mitomycin C. MAIN OUTCOME MEASURES: The primary outcome was health-related quality of life measured with the Visual Function Questionnaire-25 at 2 years post randomisation. Secondary outcomes were mean intraocular pressure; EQ-5D-5L; Health Utilities Index 3; Glaucoma Utility Index; cost and cost-effectiveness; generic, vision-specific and disease-specific health-related quality of life; clinical effectiveness; and safety. RESULTS: A total of 453 participants were recruited. The mean age of the participants was 67 years (standard deviation 12 years) in the trabeculectomy arm and 68 years (standard deviation 12 years) in the medical management arm. Over 65% of participants were male and more than 80% were white. At 24 months, the mean difference in Visual Function Questionnaire-25 score was 1.06 (95% confidence interval -1.32 to 3.43; p = 0.383). There was no evidence of a difference between arms in the EQ-5D-5L score, the Health Utilities Index or the Glaucoma Utility Index. At 24 months, the mean intraocular pressure was 12.40 mmHg in the trabeculectomy arm and 15.07 mmHg in the medical management arm (mean difference -2.75 mmHg, 95% confidence interval -3.84 to -1.66 mmHg; p < 0.001). Fewer types of glaucoma eye drops were required in the trabeculectomy arm. LogMAR visual acuity was slightly better in the medical management arm (mean difference 0.07, 95% confidence interval 0.02 to 0.11; p = 0.006) than in the trabeculectomy arm. There was no evidence of difference in safety between the two arms. A discrete choice experiment updated the utility values for the Glaucoma Utility Index. The within-trial economic analysis found a small increase in the mean EQ-5D-5L score (0.04) and that trabeculectomy has a higher probability of being cost-effective than medical management. The incremental cost of trabeculectomy per quality-adjusted life-year was £45,456. Therefore, at 2 years, surgery is unlikely to be considered cost-effective at a threshold of £20,000 per quality-adjusted life-year. When extrapolated over a patient's lifetime in a model-based analysis, trabeculectomy, compared with medical treatment, was associated with higher costs (average £2687), a larger number of quality-adjusted life-years (average 0.28) and higher incremental cost per quality-adjusted life-year gained (average £9679). The likelihood of trabeculectomy being cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life year gained was 73%. CONCLUSIONS: Our results suggested that there was no difference between treatment arms in health-related quality of life, as measured with the Visual Function Questionnaire-25 at 24 months. Intraocular pressure was better controlled in the trabeculectomy arm, and this may reduce visual field progression. Modelling over the patient's lifetime suggests that trabeculectomy may be cost-effective over the range of values of society's willingness to pay for a quality-adjusted life-year. FUTURE WORK: Further follow-up of participants will allow us to estimate the long-term differences of disease progression, patient experience and cost-effectiveness. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56878850. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 72. See the NIHR Journals Library website for further project information.

Glaucoma is an eye condition in which the intraocular pressure is too high, causing damage to the optic nerve and loss of vision. Patients with severe vision loss at diagnosis are the most at risk of blindness in their lifetime. Lowering pressure in the eye is the only way to prevent further vision loss. Two treatments to lower pressure are commonly used: using eye drops or having an operation known as a trabeculectomy. In England, Wales and Northern Ireland, the National Institute for Health and Care Excellence recommends surgery as the first treatment. However, we do not know which treatment is best for preventing vision loss or which is safest, has the best patient experience or provides the best value for money for the NHS. Therefore, surgery is not usually carried out in the first instance and patients start with eye drops instead. This study compared whether starting treatment with eye drops affected the quality of life of patients with advanced glaucoma more or less than starting treatment with trabeculectomy. We also investigated if initial treatment with surgery and initial treatment with eye drops were equally good at controlling pressure and were equally safe, and how much each treatment cost the NHS. Every patient had an equal chance of starting treatment with surgery or eye drops and they participated in the study for 2 years. We found that quality of life was similar regardless of treatment. Those starting with surgery had lower pressure and needed far fewer types of eye drops than those starting with eye drops. Thirty-nine patients in the eye drop arm required surgery to control their glaucoma. Initial treatment with eye drops was cheaper over 2 years' follow-up. Our study suggests that, over a 2-year period, having surgery in the first instance lowers intraocular pressure more than eye drops and is equally as safe as eye drops. Although eye drops are a cheaper treatment option for the NHS, if the effects of surgery on intraocular pressure are lasting, then the increased cost may be justified.

Primary trabeculectomy for advanced glaucoma: pragmatic multicentre randomised controlled trial (TAGS).

OBJECTIVE: To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma. DESIGN: Pragmatic multicentre randomised controlled trial. SETTING: 27 secondary care glaucoma departments in the UK. PARTICIPANTS: 453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017. INTERVENTIONS: Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) MAIN OUTCOME MEASURES: Primary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months. SECONDARY OUTCOMES: general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety. RESULTS: At 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval -1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference -2.8 (-3.8 to -1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare. CONCLUSION: Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication. TRIAL REGISTRATION: Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.

Factors affecting visual recovery after successful repair of macula-off retinal detachments: findings from a large prospective UK cohort study.

OBJECTIVE: To identify risk factors affecting visual outcomes in successfully re-attached macula-off rhegmatogenous retinal detachment (RD) surgery. DESIGN: A prospective study, using online databases, of visual outcomes for 2074 macula-off retinal detachments that were successfully re-attached by vitrectomy and internal tamponade. The database included detailed retinal diagrams of each detachment. MAIN OUTCOME MEASURE: The probability of achieving a post-operative visual acuity (VA) of ≤0.30 LogMAR (Snellen 6/12 or better). RESULTS: Male patients accounted for 64.9% of the sample and the median age was 63 years old. The median pre-operative VA was counting fingers (LogMAR 1.98); this improved to 0.41 LogMAR post-operatively. A post-operative VA of ≤0.30 LogMAR was achieved for 1012 (48.8%) eyes and the factors affecting this were the patient age and gender, pre-operative VA, duration of central vision loss, PVR grade, lens status, total RD and the presence of any ocular co-pathology where the model area under the receiver operator curve was 71.6%. CONCLUSIONS: From the identified risk factors that decrease the probability of achieving a post-operative visual acuity of ≤0.30 LogMAR, the most important modifiable risk factor was the duration of central vision loss. Recent macula-off retinal detachments should be repaired within 72 h of the loss of central vision.

A stakeholder meeting exploring the ethical perspectives of immediately sequential bilateral cataract surgery.

PURPOSE: The purported benefits and risks of immediately sequential bilateral cataract surgery (ISBCS) have been well described, yet the procedure remains controversial among UK ophthalmologists. As many of the controversies of ISBCS are underpinned by ethical dilemmas, the aim of this work was to explore the ethical perspectives of ISBCS from a variety of stakeholder viewpoints. METHOD: A semi-structured independent stakeholder meeting was convened at the Royal College of Ophthalmologists London headquarters in June 2018. In total, 29 stakeholders attended the meeting. The professional characteristics of stakeholders included but were not limited to: ophthalmologists (9), patients (5), religious leaders (4), ethicists (2), lawyers (2) and commissioners (1). Thematic qualitative analysis using methodology proposed by Braun and Clarke was conducted on the resultant transcript of the discussion. RESULTS: Themes identified include: (1) beneficence and non-maleficence (patient benefits, patient risks, the uncertainties of risk, patient interpretation of the risk-benefit analysis); (2) autonomy (informed consent, the barriers to communication); (3) distributive justice (the allocation of resources: the individual vs the collective). CONCLUSION: This analysis provides a reference point for the ethical factors surrounding ISBCS. The stakeholders concluded that this approach was an ethical undertaking provided patient autonomy was appropriately attained. This requires a patient's interpretation of the risk-benefit balance, which must include an understanding of the low but unquantifiable risk of severe complications. A surgeon must aim to minimise risks through the adaption of accepted surgical protocols and by performing appropriate patient selection. Currently, cost savings to healthcare that may occur following the implementation of ISBCS should be considered a secondary benefit of the protocol.

Intraocular Pressure Reduction After Real-world Cataract Surgery.

PRéCIS:: A large cohort undergoing cataract extraction was retrospectively analyzed to ascertain the degree of real-world intraocular pressure (IOP) reduction in normal eyes and those with glaucoma, and a predictive formula was developed. PURPOSE: The purpose of this study was to define the real-world degree of IOP reduction after cataract extraction to guide its role as an isolated intervention for glaucoma. MATERIALS AND METHODS: A retrospective analysis was carried out of clinical data collected in 8 clinical sites in the United Kingdom from an electronic medical record system between January 2006 and May 2015. A total of 20,508 eyes without known pathology and 2251 eyes from patients with glaucoma undergoing phacoemulsification and intraocular lens insertion were included. Eyes with intraoperative complications, undergoing additional procedures, axial lengths outside 22 to 26.5 mm, preoperative IOP under 6 mm Hg or over 30 mm Hg, and copathology, except for amblyopia or glaucoma, were excluded. The main outcome measure was the change in preoperative IOP compared with the next recorded visit for up to 12 weeks. RESULTS: In eyes without pathology, the mean reduction in IOP was 1.40 mm Hg (±3.74) compared with 1.03 (±5.02), P-value <0.001, in eyes with a diagnosis of glaucoma. A multiple linear regression model identified preoperative IOP, a glaucoma diagnosis, preoperative corrected visual acuity, age, and axial length as determinants of IOP reduction. The model was validated against an independent cohort. CONCLUSIONS: We quantify mean IOP reduction achieved in a real-world setting from cataract surgery alone. In glaucomatous eyes where angle closure is not differentiated, phacoemulsification alone yields only a modest reduction of IOP.

Mapping to Quality of Life and Capability Measures in Cataract Surgery Patients: From Cat-PROM5 to EQ-5D-3L, EQ-5D-5L, and ICECAP-O Using Mixture Modelling.

Objectives. Cataract is a prevalent and potentially blinding eye condition. Cataract surgery, the only proven treatment for this condition, is a very frequently undertaken procedure. The objective of this analysis was to develop a mapping algorithm that could be used to predict quality of life and capability scores from the Cat-PROM5, a newly developed, validated patient-reported outcome measure for patients undergoing cataract surgery. Methods. We estimated linear models and adjusted limited dependent variable mixture models. Data were taken from the Predict-CAT cohort of up to 1181 patients undergoing cataract surgery at two sites in England. The Cat-PROM5 was mapped to two quality of life measures (EQ-5D-3L and EQ-5D-5L) and one capability measure (ICECAP-O). All patients reported ICECAP-O and one or other of the EQ-5D measures both before and after cataract surgery. Model performance was assessed using likelihood statistics, graphical inspections of model fit, and error measurements. Results. Adjusted limited dependent variable mixture models dominated linear models on all performance criteria. Mixture models offered very good fit. Three component models that allowed component membership to be a function of covariates (age, sex, and diabetic status depending on specification and outcome measure) and which conditioned on covariates offered the best performance in almost all cases. An exception was the EQ-5D-5L post-surgery for which a two-component model was selected. Conclusions. Mapping from Cat-PROM5 to quality of life and capability measures using adjusted limited dependent variable mixture models is feasible, and the estimates can be used to support cost-effectiveness analysis in relation to cataract care. Mixture models performed strongly for both quality of life outcomes and capability outcomes.

Progression from ocular hypertension to visual field loss in the English hospital eye service.

BACKGROUND: There are more than one million National Health Service visits in England and Wales each year for patients with glaucoma or ocular hypertension (OHT). With the ageing population and an increase in optometric testing, the economic burden of glaucoma-related visits is predicted to increase. We examined the conversion rates of OHT to primary open-angle glaucoma (POAG) in England and assessed factors associated with risk of conversion. METHODS: Electronic medical records of 45 309 patients from five regionally different glaucoma clinics in England were retrospectively examined. Conversion to POAG from OHT was defined by deterioration in visual field (two consecutive tests classified as stage 1 or worse as per the glaucoma staging system 2). Cox proportional hazards models were used to examine factors (age, sex, treatment status and baseline intraocular pressure (IOP)) associated with conversion. RESULTS: The cumulative risk of conversion to POAG was 17.5% (95% CI 15.4% to 19.6%) at 5 years. Older age (HR 1.35 per decade, 95% CI 1.22 to 1.50, p<0.001) was associated with a higher risk of conversion. IOP-lowering therapy (HR 0.45, 95% CI 0.35 to 0.57, p<0.001) was associated with a lower risk of conversion. Predicted 5-year conversion rates for treated and untreated groups were 14.0% and 26.9%, respectively. CONCLUSION: Less than one-fifth of OHT patients managed in glaucoma clinics in the UK converted to POAG over a 5-year period, suggesting many patients may require less intensive follow-up. Our study provides real-world evidence for the efficacy of current management (including IOP-lowering treatment) at reducing risk of conversion.

Baseline Characteristics of Participants in the Treatment of Advanced Glaucoma Study: A Multicenter Randomized Controlled Trial.

PURPOSE: To report the baseline characteristics of participants enrolled in TAGS (Treatment of Advanced Glaucoma Study). DESIGN: Pragmatic randomized control trial (RCT). METHODS: Participants with newly diagnosed advanced glaucoma in at least 1 eye were recruited. Participants were patients with open angle glaucoma presenting with advanced glaucoma in at least 1 eye as defined by the Hodapp-Parrish-Anderson (HPA) criteria for severe defect. Participants were randomly allocated to receive either primary augmented trabeculectomy or primary medical management. When both eyes were eligible, the same intervention was undertaken in both eyes, and the index eye for analysis was the eye with the less severe visual field mean defect (MD). Main outcome measurements were visual field profile, defined by the HPA classification; clinical characteristics; quality of life, as measured by the National Eye Institute Visual Function Questionnaire 25 (VFQ-25), the EuroQual-5 Dimension (EQ-5D 5L), Health Utility Index-3 (HUI-3), and the Glaucoma Profile Instrument (GPI). RESULTS: A total of 453 patients were recruited. The mean visual field MD was -15.0 dB ± 6.3 in the index eye and -6.2 dB in the non-index eye. Of index eyes (HPA "severe" classification) at baseline, more than 70% of participants had a MD <-12.00 dB, and nearly 90% had more than 20 points defective at the 1% level. The mean LogMAR visual acuity of the index eye was 0.2 ± 0.3. CONCLUSIONS: TAGS is the first RCT to compare medical versus surgical treatments for patients presenting with advanced open angle glaucoma in a publicly funded health service. The study will provide clinical, health-related quality of life, and economic outcomes to inform future treatment choices for those presenting with advanced glaucoma.

Assessing the construct validity and responsiveness of Preference-Based Measures (PBMs) in cataract surgery patients.

PURPOSE: The validity and responsiveness of the EQ-5D-3L in visual conditions has been questioned, inspiring development of a vision 'bolt-on' domain (EQ-5D-3L + VIS). Developments in preference-based measures (PBM) also includes the EQ-5D-5L and the ICECAP-O capability wellbeing measure. This study aimed to examine the construct validity and responsiveness of the EQ-5D-3L, EQ-5D-5L, EQ-5D-3L + VIS and ICECAP-O in cataract surgery patients for the first time, to inform choice of PBM for economic evaluation in this population. METHODS: The analyses used data from the UK Predict-CAT cataract surgery cohort study. PBMs and the Cat-PROM5 [a validated measure of cataract quality of life (QOL)] were completed before surgery and 4-8 weeks after. Construct validity was assessed using correlations and known-group differences evaluated using regression. Responsiveness was evaluated using effect sizes and analysis of variance to compare change scores between groups, defined by patient-reported and clinical outcomes. RESULTS: The sample comprised 1315 patients at baseline. No PBMs were associated with visual acuity and only the ICECAP-O (Spearman's rs = - 0.35), EQ-5D-3L + VIS (rs = - 0.42) and EQ-5D-5L (Value Set for England rs = - 0.31) correlated at least moderately with the Cat-PROM5. Effect sizes of change were consistently largest for the EQ-5D-3L + VIS (range 0.34-0.41), followed by the ICECAP-O (range 0.20-0.34). Results indicated no improvement in responsiveness using the EQ-5D-5L (range 0.13-0.16) compared to the EQ-5D-3L (range 0.17-0.20). CONCLUSIONS: Whilst no PBMs comprehensively demonstrated evidence of construct validity and responsiveness in cataract surgery patients, the ICECAP-O was the most responsive generic PBM to improvements in QOL. Surprisingly the EQ-5D-5L was not more responsive than the EQ-5D-3L in this setting.

Assessment of the accuracy of new and updated intraocular lens power calculation formulas in 10 930 eyes from the UK National Health Service.

PURPOSE: To compare the accuracy of new/updated methods of intraocular lens (IOL) power calculation (Kane, Hill-RBF 2.0, and Holladay 2 with new axial length adjustment) with that of established methods (Barrett Universal II, Olsen, Haigis, Holladay 1, Hoffer Q, and SRK/T). SETTING: Bristol Eye Hospital, University Hospitals Bristol National Health Service, Foundation Trust, Bristol, UK. DESIGN: Retrospective consecutive case series. METHODS: Data from patients having uneventful cataract surgery with the insertion of 1 of 4 IOL types were included. Optimized IOL constants were used to calculate the predicted refraction of each formula for each patient. This was compared with the actual refractive outcome to give the prediction error. A subgroup analysis occurred based on the axial length and IOL type. RESULTS: The study included 10 930 eyes of 10 930 patients with the Kane formula having the lowest mean absolute prediction error (MAE), which was statistically significant (P < .001 in all cases) followed by the Hill 2.0, Olsen, Holladay 2, Barrett Universal 2, Holladay 1, SRK/T, Haigis, and Hoffer Q formula. The percentage of eyes predicted within ±0.5 D was Kane, 72%; Hill 2.0, 71.2%; Olsen, 70.6%; Holladay 2, 71%; Barrett 2, 70.7%; SRK/T, 69.1%; Haigis, 69%; and Hoffer Q, 68.1%. The Kane formula had the lowest MAE for short, medium, and long axial length subgroups and for each IOL type assessed. The updated versions of the Holladay 2 and Hill 2.0 formulas have resulted in improved accuracy. CONCLUSIONS: Overall and in each axial length subgroup, the Kane formula was more accurate than the other formulas.

The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: Report 7, immediate sequential bilateral cataract surgery in the UK: Current practice and patient selection.

BACKGROUND: Cataract extraction is the most frequently performed surgical intervention in the world and demand is rising due to an ageing demography. One option to address this challenge is to offer selected patients immediate sequential bilateral cataract surgery (ISBCS). This study aims to investigate patient and operative characteristics for ISBCS and delayed bilateral cataract surgery (DSCS) in the UK. METHODS: Data were analysed from the Royal College of Ophthalmologists' National Ophthalmology Database Audit (NOD) of cataract surgery. Eligible patients were those undergoing bilateral cataract extraction from centres with a record of at least one ISBCS operation between 01/04/2010 and 31/08/2018. Variable frequency comparison was undertaken with chi-square tests. RESULTS: During the study period, 1073 patients had ISBCS and 248,341 DSCS from 73 centres. A higher proportion of ISBCS patients were unable to lie flat (11.3% vs. 1.8%; p < 0.001), unable to cooperate (9.7% vs. 2.7%; p < 0.001); underwent general anaesthesia (58.7% vs. 6.6% (p < 0.001)); had brunescent/white/mature cataracts (odds ratio (OR) 5.118); no fundal view/vitreous opacities (OR 8.381); had worse pre-operative acuity 0.60 LogMAR ISBCS vs. 0.50 (first) and 0.40 (second eye) DSCS and were younger (mean ages, 71.5 vs. 75.6 years; p < 0.001). Posterior capsular rupture (PCR) rates adjusted for case complexity were comparable (0.98% ISBCS and 0.78% DSCS). CONCLUSIONS: ISBCS was performed on younger patients, with difficulty cooperating and lying flat, worse pre-operative vision, higher rates of known PCR risk factors and more frequent use of general anaesthesia than DSCS in centres recorded on NOD.

The Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 4, equity of access to cataract surgery.

OBJECTIVE: To determine whether socioeconomic status influenced the presenting visual acuity prior to first eye cataract surgery in the English National Health Service. Retrospective case series from The Royal College of Ophthalmologists' National Ophthalmology Database Audit. In total 154,223 patients undergoing first eye cataract surgery at 68 centres in England performed between 1st September 2015 and 31st August 2017. MAIN OUTCOME MEASURE: Social deprivation status and pre-operative visual acuity (VA) between centres for patients undergoing first eye cataract surgery in England. RESULTS: The median social deprivation varied between centres and ranged from decile 2 (2nd most deprived decile) to decile 9 (2nd least deprived decile). The pre-operative VA was reported for 143,401 (93.0%) eyes. The median pre-operative VA was 0.50 LogMAR (6/19), and 27.7% eyes had a preoperative VA of 0.30 LogMAR units (6/12) or better. The median pre-operative VA for each centre ranged from 0.30 to 0.60 LogMAR (6/12 to 6/24). The median pre-operative VA was mostly stable across deciles of social deprivation (0.60 LogMAR for decile 1 and 0.50 LogMAR for all other deciles), and some evidence was found linking greater deprivation to worse pre-operative VA and to lower levels of access. CONCLUSIONS: We found no strong evidence of inequality for gaining access to first eye cataract surgery in this National Ophthalmology Database analysis, however there was a possible trend towards fewer people in the more deprived deciles accessing surgery, and that some of these are presenting with quite marked levels of visual impairment.

Royal College of Ophthalmologists' National Ophthalmology Database study of cataract surgery: report 6. The impact of EyeSi virtual reality training on complications rates of cataract surgery performed by first and second year trainees.

OBJECTIVE: To investigate the impact of EyeSi surgical simulators on posterior capsule rupture (PCR) rates of cataract surgery performed by first and second year trainee surgeons. DESIGN: A Royal College of Ophthalmologists' National Ophthalmology Database audit study of first and second year surgeons' PCR rates over seven consecutive National Health Service (NHS) years. Participating centres were contacted to ascertain the date when their surgeons had access to an EyeSi machine and whether this was on-site or off-site. Operations were classified as before, after or no access to EyeSi. SETTING: The study took place in 29 NHS Ophthalmology Units in a secondary care setting. RESULTS: Two-hundred and sixty five first and second year trainee surgeons performed 17 831 cataract operations. 6919 (38.8%) operations were performed before access to an EyeSi, 8648 (48.5%) after access to an EyeSi and 2264 (12.7%) operations by surgeons with no access to an EyeSi. Overall, there was a 38% reduction in the first and second year surgeon's unadjusted PCR rates from 4.2% in 2009 to 2.6% in 2015 for surgeons with access to an EyeSi, and a 3% reduction from 2.9% to 2.8% for surgeons without access to an EyeSi. The overall first and second year unadjusted PCR rates for before, after and no access to EyeSi were 3.5%, 2.6% and 3.8%, respectively. The decrease in the with-access to an EyeSi group PCR rate was similar for surgeons with access to an EyeSi 'on site' or 'off site'. CONCLUSIONS: First and second year trainee surgeons' unadjusted PCR rates have decreased since 2009 which has significant benefits for patients undergoing cataract surgery. This 38% reduction in complication rates aligns with the introduction of EyeSi simulator training.

Auditing service delivery in glaucoma clinics using visual field records: a feasibility study.

OBJECTIVE: This study aimed to demonstrate that large-scale visual field (VF) data can be extracted from electronic medical records (EMRs) and to assess the feasibility of calculating metrics from these data that could be used to audit aspects of service delivery of glaucoma care. METHOD AND ANALYSIS: Humphrey visual field analyser (HFA) data were extracted from Medisoft EMRs from five regionally different clinics in England in November 2015, resulting in 602 439 records from 73 994 people. Target patients were defined as people in glaucoma clinics with measurable and sustained VF loss in at least one eye (HFA mean deviation (MD) outside normal limits ≥2 VFs). Metrics for VF reliability, stage of VF loss at presentation, speed of MD loss, predicted loss of sight years (bilateral VF impairment) and frequency of VFs were calculated. RESULTS: One-third of people (34.8%) in the EMRs had measurable and repeatable VF loss and were subject to analyses (n=25 760 patients). Median (IQR) age and presenting MD in these patients were 71 (61, 78) years and -6 (-10, -4) dB, respectively. In 19 264 patients with >4 years follow-up, median (IQR) MD loss was -0.2 (-0.8, 0.3) dB/year and median (IQR) intervals between VF examinations was 11 (8, 16) months. Metrics predicting loss of sight years and reliability of examinations varied between centres (p<0.001). CONCLUSION: This study illustrates the feasibility of assessing aspects of health service delivery in glaucoma clinics through analysis of VF databases. Proposed metrics could be useful for blindness prevention from glaucoma in secondary care centres.