Consensus generation of a minimum set of outcome measures for auditing glaucoma surgery outcomes-a Delphi exercise.

PURPOSE: To identify the key set of glaucoma surgery outcome measures considered most important and practical to collect by glaucoma specialists. METHODS: One hundred two glaucoma specialists (57 members of the UK and Eire Glaucoma Society (UKEGS) and 45 members of the European Glaucoma society (EGS)) took part in an Online Delphi exercise. The RAND/UCLA appropriateness method was used analyse data from each round and generate a disagreement index. RESULTS: Participants agreed on 13 baseline data points and 12 outcomes that were considered important and practical to collect. For intraocular pressure (IOP) percentage reduction in IOP from baseline (last three IOP readings pre-op) and reduction below a specified target were considered important. For visual fields, change in a global visual field index, e.g. MD, and development of progression as assessed by linear regression were considered important. From a safety perspective, any visual loss resulting in a doubling of the minimal angle of resolution, loss of 5 dB or more of visual field or development of advanced field loss (Hodapp Parrish Anderson Stage 4) was considered important. The importance of routinely using patient reported outcome measures (PROMs) was highlighted. Consensus suggested that outcomes of glaucoma treatments should be reported at 1, 5 and 10 years. CONCLUSIONS: There was broad consensus on a minimum dataset for reporting the outcomes of glaucoma surgery and outcome measurement intervals.

Nuevo abordaje para el tratamiento del glaucoma por cierre angular primario tras el estudio EAGLE / A new approach for the management of primary angle-closure glaucoma after EAGLE trial

No disponible

Monitoring ocular hypertension, how much and how often? A cost-effectiveness perspective.

OBJECTIVE: To assess the efficiency of alternative monitoring services for people with ocular hypertension (OHT), a glaucoma risk factor. DESIGN: Discrete event simulation model comparing five alternative care pathways: treatment at OHT diagnosis with minimal monitoring; biennial monitoring (primary and secondary care) with treatment if baseline predicted 5-year glaucoma risk is ≥6%; monitoring and treatment aligned to National Institute for Health and Care Excellence (NICE) glaucoma guidance (conservative and intensive). SETTING: UK health services perspective. PARTICIPANTS: Simulated cohort of 10 000 adults with OHT (mean intraocular pressure (IOP) 24.9 mm Hg (SD 2.4). MAIN OUTCOME MEASURES: Costs, glaucoma detected, quality-adjusted life years (QALYs). RESULTS: Treating at diagnosis was the least costly and least effective in avoiding glaucoma and progression. Intensive monitoring following NICE guidance was the most costly and effective. However, considering a wider cost-utility perspective, biennial monitoring was less costly and provided more QALYs than NICE pathways, but was unlikely to be cost-effective compared with treating at diagnosis (£86 717 per additional QALY gained). The findings were robust to risk thresholds for initiating monitoring but were sensitive to treatment threshold, National Health Service costs and treatment adherence. CONCLUSIONS: For confirmed OHT, glaucoma monitoring more frequently than every 2 years is unlikely to be efficient. Primary treatment and minimal monitoring (assessing treatment responsiveness (IOP)) could be considered; however, further data to refine glaucoma risk prediction models and value patient preferences for treatment are needed. Consideration to innovative and affordable service redesign focused on treatment responsiveness rather than more glaucoma testing is recommended.

Design characteristic of randomised controlled trials for geographic atrophy in age-related macular degeneration: selection of outcomes and sample size calculation.

PURPOSE: The selection of suitable outcomes and sample size calculation are critical factors in the design of a randomised controlled trial (RCT). The goal of this study was to identify the range of outcomes and information on sample size calculation in RCTs on geographic atrophy (GA). METHODS: We carried out a systematic review of age-related macular degeneration (AMD) RCTs. We searched MEDLINE, EMBASE, Scopus, Cochrane Library, www.controlled-trials.com, and www.ClinicalTrials.gov. Two independent reviewers screened records. One reviewer collected data and the second reviewer appraised 10% of collected data. We scanned references lists of selected papers to include other relevant RCTs. RESULTS: Literature and registry search identified 3816 abstracts of journal articles and 493 records from trial registries. From a total of 177 RCTs on all types of AMD, 23 RCTs on GA were included. Eighty-one clinical outcomes were identified. Visual acuity (VA) was the most frequently used outcome, presented in 18 out of 23 RCTs and followed by the measures of lesion area. For sample size analysis, 8 GA RCTs were included. None of them provided sufficient Information on sample size calculations. CONCLUSIONS: This systematic review illustrates a lack of standardisation in terms of outcome reporting in GA trials and issues regarding sample size calculation. These limitations significantly hamper attempts to compare outcomes across studies and also perform meta-analyses.

Cataract extraction and patient vision-related quality of life: a cohort study.

AIMS: Cataract surgery is one of the most common surgeries performed, but its overuse has been reported. The threshold for cataract surgery has become increasingly lenient; therefore, the selection process and surgical need has been questioned. The aim of this study was to evaluate the changes associated with cataract surgery in patient-reported vision-related quality of life (VR-QoL). METHODS: A prospective cohort study was conducted. Consecutive patients referred to cataract clinics in an NHS unit in Scotland were identified. Those listed for surgery were invited to complete a validated questionnaire (TyPE) to measure VR-QoL pre- and post-operatively. TyPE has five different domains (near vision, distance vision, daytime driving, night-time driving, and glare) and a global score of vision. The influence of pre-operative visual acuity (VA) levels, vision, and lens status of the fellow eye on changes in VR-QoL were explored. RESULTS: A total of 320 listed patients were approached, of whom 36 were excluded. Among the 284 enrolled patients, 229 (81%) returned the questionnaire after surgery. Results revealed that the mean overall vision improved, as reported by patients. Improvements were also seen in all sub-domains of the questionnaire. CONCLUSION: The majority of patients appear to have improvement in patient-reported VR-QoL, including those with good pre-operative VA and previous surgery to the fellow eye. VA thresholds may not capture the effects of the quality of life on patients. This information can assist clinicians to make more informed decisions when debating over the benefits of listing a patient for cataract extraction.

Optical coherence tomography for the diagnosis of neovascular age-related macular degeneration: a systematic review.

UNLABELLED: The purpose is to study the diagnostic performance of optical coherence tomography (OCT) and alternative diagnostic tests for neovascular age-related macular degeneration (nAMD). Methods employed are as follows:systematic review and meta-analysis; INDEX TEST: OCT including time-domain (TD-OCT) and the most recently developed spectral domain (SD-OCT); comparator tests: visual acuity, clinical evaluation (slit lamp), Amsler chart, colour fundus photographs, infra-red reflectance, red-free images/blue reflectance, fundus autofluorescence imaging (FAF), indocyanine green angiography (ICGA), preferential hyperacuity perimetry (PHP), and microperimetry; reference standard: fundus fluorescein angiography. Databases searched included MEDLINE, MEDLINE In Process, EMBASE, Biosis, SCI, the Cochrane Library, DARE, MEDION, and HTA database. Last literature searches: March 2013. Risk of bias assessed using QUADAS-2. Meta-analysis models were fitted using hierarchical summary receiver operating characteristic (HSROC) curves. Twenty-two studies (2 abstracts and 20 articles) enrolling 2124 participants were identified, reporting TD-OCT (12 studies), SD-OCT (1 study), ICGA (8 studies), PHP (3 studies), Amsler grid, colour fundus photography and FAF (1 study each). Most studies were considered to have a high risk of bias in the patient selection (55%, 11/20), and flow and timing (40%, 8/20) domains. In a meta-analysis of TD-OCT studies, sensitivity and specificity (95% CI) were 88% (46-98%) and 78% (64-88%), respectively. There was insufficient information to undertake meta-analysis for other tests. TD-OCT is a sensitive test for detecting nAMD, although specificity was only moderate. Data on SD-OCT are sparse. Diagnosis of nAMD should not rely solely on OCT.

Surgical checklist for cataract surgery: progress with the initiative by the Royal College of Ophthalmologists to improve patient safety.

PURPOSE: The World Health Organisation (WHO) identified patient safety in surgery as an important public health matter and advised the adoption of a universal peri-operative surgical checklist. An adapted version of the WHO checklist has been mandatory in the National Health Service since 2010. Wrong intraocular lens (IOL) implantation is a particular safety concern in ophthalmology. The Royal College of Ophthalmologists launched a bespoke checklist for cataract surgery in 2010 to reduce the likelihood of preventable errors. We sought to ascertain the use of checklists in cataract surgery in 2012. PATIENTS AND METHODS: A survey of members of the Royal College of Ophthalmologists seeking views on the use of checklists in cataract surgery. Four hundred and sixty-nine completed responses were received (18% response rate). RESULTS: Respondents worked in England (75%), Scotland (11%), Wales (5%), Northern Ireland (2%), the Republic of Ireland (1%), and overseas (6%). Ninety-four per cent of respondents support the use of a checklist for cataract surgery and 85% say that they always use a checklist before cataract surgery. Sixty-seven per cent of cataract surgeons stated they undertake a pre-operative team brief. Thirty-six per cent use a cataract surgery checklist developed locally, 18% use the college's bespoke cataract surgery checklist, 39% use a generic surgical checklist, and 4% reported that they do not use a checklist. CONCLUSION: Ninety-three per cent of cataract surgeons responding to the questionnaire report using a surgical checklist and 67% use a team brief. However, only 54% use a checklist, which addresses the selection of the correct intraocular implant. We recommend wider adoption of checklists, which address risks relevant to cataract surgery, in particular the possibility of selection of an incorrect IOL.

Surveillance for ocular hypertension: an evidence synthesis and economic evaluation.

OBJECTIVES: To determine effective and efficient monitoring criteria for ocular hypertension [raised intraocular pressure (IOP)] through (i) identification and validation of glaucoma risk prediction models; and (ii) development of models to determine optimal surveillance pathways. DESIGN: A discrete event simulation economic modelling evaluation. Data from systematic reviews of risk prediction models and agreement between tonometers, secondary analyses of existing datasets (to validate identified risk models and determine optimal monitoring criteria) and public preferences were used to structure and populate the economic model. SETTING: Primary and secondary care. PARTICIPANTS: Adults with ocular hypertension (IOP > 21 mmHg) and the public (surveillance preferences). INTERVENTIONS: We compared five pathways: two based on National Institute for Health and Clinical Excellence (NICE) guidelines with monitoring interval and treatment depending on initial risk stratification, 'NICE intensive' (4-monthly to annual monitoring) and 'NICE conservative' (6-monthly to biennial monitoring); two pathways, differing in location (hospital and community), with monitoring biennially and treatment initiated for a ≥ 6% 5-year glaucoma risk; and a 'treat all' pathway involving treatment with a prostaglandin analogue if IOP > 21 mmHg and IOP measured annually in the community. MAIN OUTCOME MEASURES: Glaucoma cases detected; tonometer agreement; public preferences; costs; willingness to pay and quality-adjusted life-years (QALYs). RESULTS: The best available glaucoma risk prediction model estimated the 5-year risk based on age and ocular predictors (IOP, central corneal thickness, optic nerve damage and index of visual field status). Taking the average of two IOP readings, by tonometry, true change was detected at two years. Sizeable measurement variability was noted between tonometers. There was a general public preference for monitoring; good communication and understanding of the process predicted service value. 'Treat all' was the least costly and 'NICE intensive' the most costly pathway. Biennial monitoring reduced the number of cases of glaucoma conversion compared with a 'treat all' pathway and provided more QALYs, but the incremental cost-effectiveness ratio (ICER) was considerably more than £30,000. The 'NICE intensive' pathway also avoided glaucoma conversion, but NICE-based pathways were either dominated (more costly and less effective) by biennial hospital monitoring or had a ICERs > £30,000. Results were not sensitive to the risk threshold for initiating surveillance but were sensitive to the risk threshold for initiating treatment, NHS costs and treatment adherence. LIMITATIONS: Optimal monitoring intervals were based on IOP data. There were insufficient data to determine the optimal frequency of measurement of the visual field or optic nerve head for identification of glaucoma. The economic modelling took a 20-year time horizon which may be insufficient to capture long-term benefits. Sensitivity analyses may not fully capture the uncertainty surrounding parameter estimates. CONCLUSIONS: For confirmed ocular hypertension, findings suggest that there is no clear benefit from intensive monitoring. Consideration of the patient experience is important. A cohort study is recommended to provide data to refine the glaucoma risk prediction model, determine the optimum type and frequency of serial glaucoma tests and estimate costs and patient preferences for monitoring and treatment. FUNDING: The National Institute for Health Research Health Technology Assessment Programme.

Safe eye surgery: non-technical aspects.

The traditional training of surgeons focused exclusively on developing knowledge, clinical expertise, and technical (surgical) skills. However, analyses of the reasons for adverse events in surgery have revealed that many underlying causes originate from behavioural or non-technical aspects of performance (eg, poor communication among members of the surgical team) rather than from a lack of surgical (ie, technical) skills. Therefore, technical skills appear to be necessary but not sufficient to ensure patient safety. Paying attention to non-technical skills, such as team working, leadership, situation awareness, decision making, and communication, will increase the likelihood of maintaining high levels of error-free performance. Identification and training of non-technical skills has been developed for high-risk careers, such as civil aviation and nuclear power. Only recently, training in non-technical skills has been adopted by the surgical world and anaesthetists. Non-technical skills need to be tailored to the environment where they are used, and eye surgery has some substantial differences compared with other surgical areas, for example, high volume of surgery, use of local anaesthetics, and very sophisticated equipment. This review highlights the need for identification of the non-technical skills relevant to eye surgeons and promotion of their use in the training of eye surgeons.

The effect of socio-economic deprivation on severity of glaucoma at presentation.

OBJECTIVE: To evaluate the influence of socio-economic factors on severity of glaucoma at presentation METHODS: All newly diagnosed glaucoma patients at the University Hospitals-NHS, Aberdeen and South Glasgow University Hospitals-NHS, in 2006, were included. Glaucoma was severe at presentation if there was a repeatable visual-field loss with a mean deviation index greater than 12 dB in the Humphreys visual fields test or an absolute paracentral scotoma within the central 5 degrees of the visual fields. Home address was used to determine the Scottish Index of Multiple Deprivation (SIMD) rank. The SIMD rank, demographics and severity of glaucoma at presentation were investigated using general linear modelling. RESULTS: There were 48 patients with severe glaucoma and 74 patients with non-severe glaucoma. In four, the severity could not be determined. Severity of glaucoma at presentation was significantly associated with SIMD rank, being most severe in patients from areas with the lowest ranks (p = 0.026). Age was a significant factor (p = 0.024), with severe glaucoma being more common in elderly patients. CONCLUSIONS: Age and socio-economic deprivation were associated with severity of glaucoma at presentation, with patients from areas of higher socio-economic deprivation presenting with more advanced glaucoma.

Surveillance of severe chemical corneal injuries in the UK.

AIM: To estimate the incidence of severe chemical corneal injuries in the UK and describe presenting clinical features and initial management. METHODS: All patients with severe chemical corneal injury in the UK from December 2005 to November 2006 inclusive were prospectively identified using the British Ophthalmological Surveillance Unit. Reporting ophthalmologists provided information regarding presentation and follow-up. RESULTS: Twelve cases were identified, giving a minimum estimated incidence in the UK of severe chemical corneal injury of 0.02 per 100,000. 66.7% of injuries were in males of working age, 50% occurred at work, and alkali was causative in 66.7%. Only one patient was wearing eye protection at the time of injury, 75% received immediate irrigation. Six patients required one or more surgical procedures, most commonly amniotic membrane graft. At 6 months' follow-up, the best-corrected visual acuity was 6/12 or better in five patients, and worse than 6/60 in two. CONCLUSION: The incidence of severe chemical corneal injury in the UK is low. The cases that occur can require extended hospital treatment, with substantial ocular morbidity and visual sequelae. Current enforcement of eye protection in the workplace in the UK has probably contributed to a reduced incidence of severe ocular burns.

The influence of the new general ophthalmic services (GOS) contract in optometrist referrals for glaucoma in Scotland.

PURPOSE: To assess the quality of referrals from community optometrists in the northeast of Scotland to the hospital glaucoma service before and after the implementation of the new General Ophthalmic Services (GOS) contract in Scotland. METHODS: Retrospective study encompassing two 6-month periods, one before the implementation of the new GOS (Scotland) contract in April 2006 (from June to November 2005), and the other after (from June to November 2006). The community optometrist referral forms and hospital glaucoma service notes were reviewed. Comparisons were performed using the t-test and chi (2)-test. RESULTS: In all, 183 referrals were made during the first 6-month period from June to November 2005, and 120 referrals were made during the second 6-month period from June to November 2006. After the introduction of the new GOS contract, there was a statistically significant increase in true-positive referrals (from 18.0 to 31.7%; P=0.006), decrease in false-positive referrals (from 36.6 to 31.7%; P=0.006), and increase in the number of referrals with information on applanation tonometry (from 11.8 to 50.0%; P=0.000), dilated fundal examination (from 2.2 to 24.2%; P=0.000), and repeat visual fields (from 14.8 to 28.3%; P=0.004) when compared to the first 6-month period. However, only 41.7% of referrals fulfilled the new GOS contract requirements, with information on applanation tonometry the most commonly missing. CONCLUSIONS: After the implementation of the new GOS (Scotland) contract in April 2006, there has been an improvement in the quality of the glaucoma referrals from the community optometrists in the northeast of Scotland, with a corresponding reduction in false-positive referrals. Despite the relatively positive effect so far, there is still scope for further improvement.

Detection of visual-field deterioration by Glaucoma Progression Analysis and Threshold Noiseless Trend programs.

BACKGROUND: To compare the ability of Glaucoma Progression Analysis (GPA) and Threshold Noiseless Trend (TNT) programs to detect visual-field deterioration. METHODS: Patients with open-angle glaucoma followed for a minimum of 2 years and a minimum of seven reliable visual fields were included. Progression was assessed subjectively by four masked glaucoma experts, and compared with GPA and TNT results. Each case was judged to be stable, deteriorated or suspicious of deterioration RESULTS: A total of 56 eyes of 42 patients were followed with a mean of 7.8 (SD 1.0) tests over an average of 5.5 (1.04) years. Interobserver agreement to detect progression was good (mean kappa = 0.57). Progression was detected in 10-19 eyes by the experts, in six by GPA and in 24 by TNT. Using the consensus expert opinion as the gold standard (four clinicians detected progression), the GPA sensitivity and specificity were 75% and 83%, respectively, while the TNT sensitivity and specificity was 100% and 77%, respectively. CONCLUSION: TNT showed greater concordance with the experts than GPA in the detection of visual-field deterioration. GPA showed a high specificity but lower sensitivity, mainly detecting cases of high focality and pronounced mean defect slopes.

Late-stage, primary open-angle glaucoma in Europe: social and health care maintenance costs and quality of life of patients from 4 countries.

OBJECTIVE: The purpose of this study was to estimate costs and quality of life (QoL) of late-stage glaucoma patients in 4 European countries. METHODS: Retrospective review of medical charts of patients with POAG who were followed in a low-vision or vision rehabilitation center in one of 4 countries for at least 1 year was used to determine patient characteristics, health status, and health care resource use. Visual impairment was measured by best-corrected visual acuity (Snellen score). Patients were also interviewed over the telephone in order to assess their health-related QoL (using EuroQol EQ-5D) and use of resources including: the number of visits to rehabilitation centers, visits to hospital and non-hospital specialists, the use of low-vision devices, medication, tests, and the use of hired home help. The costs associated with resource use were calculated from the perspective of a third-party payer of health and social care based on resource usage and unit costs in each country. RESULTS: Patients undergoing visual rehabilitation in France (n=21), Denmark (n=59), Germany (n=60), and the United Kingdom (n=22) were identified, interviewed and had their medical charts reviewed. Annual maintenance costs of late-stage glaucoma amounted to euro830 (+/-445) on average. Average home help costs were more than 3 times higher. QoL, on average, was 0.65 (+/-0.28). QoL was positively correlated with the level of visual acuity in the patients' best eye. On the other hand, visual acuity was also positively correlated to health care costs, but negatively correlated to costs of home help. CONCLUSIONS: The study was limited by its observational, uncontrolled design. The finding that late-stage glaucoma is associated with higher home help costs than health care maintenance costs suggests that potential savings from a better preventive treatment are to be found for social care payers rather than health care payers.

Increasing the size of a small peripheral iridotomy widens the anterior chamber angle: an ultrasound biomicroscopy study.

PURPOSE: A peripheral iridotomy (PI) is the treatment of choice for pupillary block. In this study we investigated the effect of enlarging the size of a small PI on the anterior chamber angle in patients with angle closure using ultrasound biomicroscopy (UBM). PATIENTS AND METHODS: Patients who had been treated with laser peripheral iridotomy for angle closure and were identified to have a small patent PI (< 100 microm) with still appositionally closed anterior chamber angle were selected prospectively. The anterior chamber angle was assessed using UBM. The angle opening distance 500 microm from the scleral spur (AOD500) as well as the anterior and posterior chamber depth (ACD and PCD) 1000 microm from the scleral spur was measured. In addition, the ACD/PCD ratio was calculated. Afterwards, the PI was enlarged using an Nd: YAG laser and the UBM measurements were repeated as described above. RESULTS: Six eyes of six patients were examined. After the enlargement of the PI the average AOD500 increased from 109 microm (+/- 36) to 147 microm (+/- 40) (p < 0.05). The ACD/PCD ratio increased from 0.36 (+/- 0.065) to 0.67 (+/- 0.185) (p < 0.05). CONCLUSION: Patients with a small PI and appositionally closed anterior chamber angle should have a repeated laser treatment. The ACD/PCD ratio, measured 1000 microm from the sclerl spur, is a new method to describe the features and changes of the anterior chamber angle taking into account the configuration of the iris and the posterior chamber depth.

A review of glaucoma treatment in Scotland 1994-2004.

OBJECTIVE: This study evaluated the changing trends in glaucoma management in Scotland between 1994 and 2004. METHODS: A retrospective analysis of national health statistics in Scotland from 1994 to 2004. The Scottish morbidity record was used to collect information on all episodes of trabeculectomy. Data on number of prescriptions were gathered for individual drugs and also for groups of active ingredient. The population likely to have glaucoma (PLG) was calculated from estimates of prevalence in individuals aged 40 years and older, based on published epidemiological studies. The outcome measures were trabeculectomy rates, corrected for population likely to be at risk of glaucoma (PLG), and prescribing volume and cost for glaucoma medications. RESULTS: Trabeculectomy rates have fallen by 67% from 46 per 1,000 PLG in 1994 to 15.4 per 1,000 PLG in 2004. Over the same time period, the population likely to be at risk of glaucoma (PLG) increased by 16.6%. The cost of prescribing has increased by 122% over 11 years compared with an increase in number of items per 1,000 PLG by 27.5%. In 1994, beta-blockers accounted for 65.2% of prescribed drugs but by 2004 this had dropped to 33%. Since their introduction, the prescribing of prostaglandin analogues has increased rapidly and in 2004, they accounted for 39.4% of prescribed drugs. CONCLUSION: The increasing use of prostaglandin analogues has led to an increase in prescribing rates and a rapid increase in cost. At the same time, prescribing of beta-blockers has declined and trabeculectomy rates have fallen.