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.

Profiling ocular surface responses to preserved and non-preserved topical glaucoma medications: A 2-year randomized evaluation study.

BACKGROUND: Use of topical glaucoma medications has been reported to cause ocular surface (OS) discomfort and inflammation. This study explores the profile of inflammatory cytokines and OS symptoms induced in response to preserved and non-preserved drops. METHODS: Prospective, randomized evaluation on 36 treatment-naïve patients over 24 months of three differently preserved glaucoma drop preparations: Preservative-free (PF), polyquad (PQ) and benzalkonium chloride (BAK). Study participants were evaluated at baseline and then at 1, 3, 6, 12 and 24 months while on medication. At each visit, participants completed the OS disease index (OSDI) questionnaire, had basal tear sampling and impression cytology (IC) of the conjunctival epithelium. Quantitative polymerase chain reaction was performed to measure the gene expression of inflammatory cytokines [interleukin (IL)-6, IL-8, IL-10, IL-12A, IL-12B, IL-17A, IL-1ß and tumour necrosis factor-α] in the IC samples. Corresponding protein expression of cytokines in tear samples was assessed by the Becton-Dickinson cytometric bead arrays. RESULTS: Compared to PF and PQ groups, mRNA and protein expression of IL-6, IL-8 and IL-1ß increased in samples from the BAK group in a time-dependent fashion, whereas all other cytokines showed a non-significant increase. In the BAK group, there was a strong correlation between OSDI and the levels of IC/IL-1ß (r = .832, R2 = .692 and P = .040); IC/IL-10 (r = .925, R2 = .856 and P = .008) and tear/IL-1ß (r = .899, R2 = .808 and P = .014). CONCLUSIONS: BAK-preserved topical drops stimulate a sterile inflammatory response on the OS within 3 months which is maintained thereafter, whereas PF-drops and PQ-preserved drops showed no significant OS inflammation.

Subconjunctival draining minimally-invasive glaucoma devices for medically uncontrolled glaucoma.

BACKGROUND: Glaucoma is a leading cause of irreversible blindness. Subconjunctival draining minimally-invasive glaucoma devices such as the Xen gelatin implant and InnFocus stent have been introduced as a treatment to prevent glaucoma progressing.These implants provide a channel to allow aqueous humour from the anterior chamber of the eye to drain into the subconjunctival space on the surface of the eye thus reducing intraocular pressure (IOP) and mimicking the mechanism of the most commonly undertaken glaucoma surgery, trabeculectomy. OBJECTIVES: To evaluate the efficacy and safety of subconjunctival draining minimally-invasive glaucoma devices in treating people with open angle glaucoma and ocular hypertension whose condition is inadequately controlled with drops. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2018, Issue 6); Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. The date of the search was 10 July 2018. SELECTION CRITERIA: We searched for randomised controlled trials (RCTs) of Xen gelatin implant or InnFocus MicroShunt to other surgical treatments (other minimally-invasive glaucoma device techniques, trabeculectomy), laser treatment or medical treatment. We also planned to include trials where these devices were combined with phacoemulsification compared to phacoemulsification alone. DATA COLLECTION AND ANALYSIS: We planned to have two review authors independently extract data from reports of included studies using a data collection form and analyse data based on methods expected by Cochrane. Our primary outcome was mean change in IOP. Secondary outcomes included proportion of participants who were drop-free; proportion of participants who achieved an IOP of 21 mmHg or less, 17 mmHg or less or 14 mmHg or less; and proportion of participants experiencing intra- and postoperative complications. We planned to measure all outcomes in the short-term (six to 18 months), medium-term (18 to 36 months), and long-term (36 months onwards). MAIN RESULTS: We found no completed RCTs that met our inclusion criteria. We found one ongoing study (NCT01881425). The study compares InnFocus MicroShunt to trabeculectomy in people with primary open angle glaucoma. The primary outcome is greater than 20% IOP reduction from baseline to 12 months' follow-up. A total of 889 people aged between 40 and 85 years have been enrolled. The estimated study completion date is November 2019. AUTHORS' CONCLUSIONS: There is currently no high-quality evidence for the effects of subconjunctival draining minimally-invasive glaucoma devices for medically uncontrolled open angle glaucoma. Properly designed RCTs are needed to assess the medium- and long-term efficacy and safety of this technique.

Exploring the frequency and location of prescribing errors in the use of topical glaucoma medications.

IMPORTANCE: Very little is known about health-care professional related prescribing errors within the glaucoma setting. BACKGROUND: This study aims to quantify these errors and to explore where they occur along the prescribing pathway. DESIGN: Cross-sectional study of patients attending a specialty glaucoma clinic over a 5-month period. PARTICIPANTS: Data was collected for 109 patients. METHODS: We compared glaucoma drop regimes from four different sources: As documented in the hospital notes for the last appointment, the letter sent to the General Practitioner (GP), patient's self-reporting and bottles/prescriptions brought to the clinic appointment. MAIN OUTCOME MEASURES: Discrepancies were identified and errors were grouped into one of four categories depending on where in the prescribing pathway they occurred: Incorrect prescribing of the drops by the clinician, incorrect prescribing of the drops by the GP/failure to provide a repeat prescription, incorrect dispensing of the drops by the pharmacist and possible non-adherence by the patient. RESULTS: There was a total of 217 individual prescription items involving 266 active ingredients. Seventy-one prescription items out of 217 (33%) had an error, of this 53 (75%) were due to possible patient non-adherence and 18 (25%) were process related errors made by health-care professionals. CONCLUSIONS AND RELEVANCE: An error was identified in 33% of prescriptions. About 8.3% of prescriptions had a health-care professional related process error. These errors are preventable and recognition of these is important to maximize drop adherence and minimize disease progression, requiring increased consultations and interventions with quality of life and health economic consequences.

Survey of glaucoma surgical preferences and post-operative care in the United Kingdom.

BACKGROUND: To evaluate the spectrum of glaucoma surgery and the post-operative follow-up regimes undertaken among glaucoma specialists in the United Kingdom. DESIGN: National survey. PARTICIPANTS: Seventy-five glaucoma specialists (consultants and fellows). METHODS: An eight-question survey was emailed to all glaucoma subspecialists members of the United Kingdom and Eire Glaucoma Society. MAIN OUTCOME MEASURES: Surgery undertaken, post-operative management, awareness of intervention tariff and handling of the follow-up burden generated through surgery. RESULTS: Almost all the participants (74/75: 99%) routinely performed trabeculectomy, 54 responders (72%) undertook tube surgery and Minimally Invasive Glaucoma Surgery (MIGS) was more frequently undertaken (33.0%) than non-penetrating surgery (23%). In general, for patients with advanced glaucoma requiring a low target intraocular pressure (IOP), the most frequent primary intervention was trabeculectomy (99%), followed by tubes (64%). Similarly, in patients with less advanced glaucoma requiring moderate target IOP, participants preferred trabeculectomy (99%), followed by MIGS (60%). By the first 6 months after the procedure, trabeculectomy and Baerveldt tube implant required a larger number of postoperative visits (9 and 7, respectively), than iStent® and non-penetrating deep sclerectomy (3 and 5, respectively). The majority of participants were not aware of the costs of their interventions. CONCLUSIONS: A wide variety of glaucoma surgery techniques are undertaken. Post-operative follow-up regimes are variable between techniques and for surgeons using the same technique. Trabeculectomy requires more follow-up than any other intervention. For patients requiring low IOP, trabeculectomy is the operation of choice for most surgeons.

Short-term effect of diode laser cyclophotocoagulation on intraocular pressure: a prospective study.

BACKGROUND: This aims to determine the immediate and short-term risk of intraocular pressure spikes following diode laser cyclophotocoagulation. DESIGN: This study is a prospective, consecutive cohort study in a UK teaching hospital. PARTICIPANTS: Fifty-three consecutive patients undergoing cyclophotocoagulation were invited to participate in this study. METHODS: Intraocular pressure (IOP) measurements were taken immediately prior to cyclodiode laser, hourly for the first 3 h after laser, on the first and seventh postoperative days, and at three months following laser. MAIN OUTCOME MEASURES: Eyes experiencing intraocular pressure elevation defined at two levels (≥3 mm Hg and ≥10 mm Hg from the pretreatment level) were identified. RESULTS: Seventeen eyes (34%) had an elevation in intraocular pressure (≥3 mmHg) during the first 3 h postoperatively with a mean increase of 10.3 mmHg. No preoperative or perioperative associations were found for a postcyclodiode spike within the first 3 postoperative hours.No association was found between pressure spikes and visual acuity, reduction of glaucoma medication or final postoperative intraocular pressure at 3 months. Eyes that did not have an IOP spike during the first 3 h postoperatively had a greater reduction in IOP at 3 months (15.2 mmHg vs. 10.2 mmHg; P = 0.184). CONCLUSION: IOP spikes are common in the immediate period after cyclophotocoagulation. An elevation in IOP is noted after the first hour in the vast majority who experience a spike in the first 3 h post-procedure.

Is primary trabeculectomy cost-effective for patients with advanced primary open angle glaucoma? Results from the Treatment of Advanced Glaucoma Study economic model.

BACKGROUND/AIMS: Advanced primary open angle glaucoma (POAG) is a lifelong condition. The aim of this study is to compare medical treatment against trabeculectomy for patients presenting with advanced POAG using an economic evaluation decision model. METHODS: A Markov model was used to compare the two treatments, medical treatment versus trabeculectomy for the management of advanced POAG, in terms of costs and quality-adjusted life-years (QALYs). The uncertainty surrounding the model findings was assessed using probabilistic sensitivity analysis and deterministic analysis. Data for the model came from Treatment of Advanced Glaucoma Study supplemented with data from the literature. The main outcomes of the model presented in terms of Incremental costs and QALYs based on responses to the EQ-5D-5L, Health Utilities Index-3 and a Glaucoma Utility Index. RESULTS: In the base-case analysis (lifetime horizon and EQ-5D-5L measure), participants receiving trabeculectomy had on average, an additional cost of £2687, an additional 0.28 QALYs and an incremental cost per QALY of £9679 compared with medical treatment. There was a 73% likelihood of trabeculectomy being considered cost-effective when society was willing to pay £20 000 for a QALY. Over shorter time horizons, the incremental cost per QALY gained from trabeculectomy compared with medical treatment was higher (47 663) for a 2-year time horizon. Our results are robust to changes in the key assumptions and input parameters values. CONCLUSION: In patients presenting with advanced POAG, trabeculectomy has a higher probability of being cost-effective over a patient's lifetime compared with medical treatment.

Effects of socioeconomic status on baseline values and outcomes at 24 months in the Treatment of Advanced Glaucoma Study randomised controlled Trial.

BACKGROUND/AIMS: Socioeconomic status (SES) is associated with late disease presentation and poorer outcomes. We evaluate the effect of SES on treatment outcomes and report the correlation between SES and baseline characteristics of participants in the Treatment of Advanced Glaucoma Study. METHODS: Pragmatic multicentre randomised controlled trial. Four hundred and fifty-three patients presenting with advanced open-angle glaucoma in at least one eye (Hodapp-Parrish-Anderson classification). Participants were randomised to either glaucoma drops (medical arm) or trabeculectomy (surgery arm). Clinical characteristics, Quality of life measurement (QoL) and SES defined by the Index of Multiple Deprivation are reported. Subgroup analysis explored treatment effect modifications of SES at 24 months. Correlation between SES and baseline characteristics was tested with the χ2 test of association for dichotomous variables and pairwise Pearson's correlation for continuous variables. RESULTS: The mean visual field mean deviation was -17.2 (6.7)dB for the most deprived quintile of participants and -13.0 (5.5) for the least deprived quintile in the index eye. At diagnosis, there was a strong correlation between SES and ethnicity, age, extent of visual field loss and number of visits to opticians prior to diagnosis. At 24 months, there was no evidence that the treatment effect was moderated by SES. CONCLUSIONS: In patients presenting with advanced glaucoma. SES at baseline is correlated with poorer visual function, poorer Visual Function Questionnaire-25 QoL, ethnicity, age and number visits to an optician in the years preceding diagnosis. SES at baseline does not have an effect of the success of treatment at 24 months. TRIAL REGISTRATION NUMBER: ISRCTN56878850.

Trabeculectomy in the 21st century: a multicenter analysis.

OBJECTIVE: To evaluate the efficacy and safety of current trabeculectomy surgery in the United Kingdom. DESIGN: Cross-sectional, multicenter, retrospective follow-up. PARTICIPANTS: A total of 428 eyes of 395 patients. METHODS: Consecutive trabeculectomy cases with open-angle glaucoma and no previous incisional glaucoma surgery from 9 glaucoma units were evaluated retrospectively. Follow-up was a minimum of 2 years. MAIN OUTCOME MEASURES: Surgical success, intraocular pressure (IOP), visual acuity, complications, and interventions. Success was stratified according to IOP, use of hypotensive medications, bleb needling, and resuturing/revision for hypotony. Reoperation for glaucoma and loss of perception of light were classified as failures. RESULTS: Antifibrotics were used in 400 cases (93%): mitomycin C (MMC) in 271 (63%), 5-fluorouracil (5-FU) in 129 (30%), and no antifibrotic in 28 (7%). At 2 years, IOP (mean ± standard deviation) was 12.4 ± 4 mmHg, and 342 patients (80%) achieved an IOP ≤ 21 mmHg and 20% reduction of preoperative IOP without IOP-lowering medication, whereas 374 patients (87%) achieved an IOP ≤ 21 mmHg and 20% reduction of preoperative IOP overall. An IOP ≤18 mmHg and 20% reduction of preoperative IOP were achieved by 337 trabeculectomies (78%) without IOP-lowering treatment and by 367 trabeculectomies (86%) including hypotensive medication. Postoperative treatments included suture manipulation in 184 patients (43%), resuturing or revision for hypotony in 30 patients (7%), bleb needling in 71 patients (17%), and cataract extraction in 111 of 363 patients (31%). Subconjunctival 5-FU injection was performed postoperatively in 119 patients (28%). Visual loss of >2 Snellen lines occurred in 24 of 428 patients (5.6%). A total of 31 of the 428 patients (7.2%) had late-onset hypotony (IOP <6 mmHg after 6 months). In 3 of these, visual acuity decreased by >2 Snellen lines. Bleb leaks were observed in 59 cases (14%), 56 (95%) of which occurred within 3 months. Two patients developed blebitis. Bleb-related endophthalmitis developed in 1 patient within 1 month postoperatively and in 1 patient at 3 years. There was an endophthalmitis associated with subsequent cataract surgery. CONCLUSIONS: This survey shows that good trabeculectomy outcomes with low rates of surgical complications can be achieved, but intensive proactive postoperative care is required.

Will the PRESERFLO™ MicroShunt impact the future of trabeculectomy practice? A UK and Éire Glaucoma Society National Survey.

BACKGROUND/OBJECTIVES: To explore the attitudes of UK glaucoma specialists regarding the current and future practice of trabeculectomy and the novel PRESERFLO™ MicroShunt (PF-MS) device, and intentions to adopt the PF-MS into routine glaucoma surgical practice. METHODS: Online survey of UK and Éire Glaucoma Society members. RESULTS: 43 glaucoma consultants completed the survey. All surgeons performed trabeculectomies (median of 40 annually) and 51% undertook PF-MS procedures (median of 22.5 annually). The mean duration of surgery was reported as 48.9 (SD 13.3) and 31.2 (SD 9.9) min for trabeculectomy and PF-MS respectively (p < 0.0001). For surgeons not currently using the PF-MS, 65% planned to do so. Respondents judged completion of 35 trabeculectomies and 10 PF-MS were required to achieve basic competence. 91% of participants predicted their trabeculectomy volume would decrease and 73% expected PF-MS usage to increase. Respondents reported a median of six and four follow-ups within 3 months post surgery for trabeculectomy and PF-MS respectively (p < 0.0001). Respondents reported trabeculectomy required more post-operative interventions than the PF-MS and 81.8% judged the patient experience to be better with the PF-MS. The PF-MS was deemed suitable for early visual field loss by 72% of respondents, severe visual field loss by 35% and normal tension glaucoma by 21%. CONCLUSION: The PF-MS has seen rapid adoption in the UK. Respondents predict its usage will significantly increase whilst trabeculectomies will decrease. They report the PF-MS is quicker to learn and perform, and requires less post-operative follow-ups and interventions which may facilitate a more efficient service delivery for patients requiring glaucoma surgery.

Technologies for the diagnosis of angle closure glaucoma (ACE): protocol of a prospective, multicentre, cross-sectional diagnostic study.

INTRODUCTION: Angle-closure is responsible for half of all glaucoma blindness globally. Patients with suspected glaucoma require assessment of the drainage angle by an experienced clinician. The goal of this study is to evaluate the diagnostic performance and cost-effectiveness of two non-contact tests, anterior segment OCT (Optical Coherence Tomography) (AS-OCT) and limbal anterior chamber depth for patients referred to hospital with suspected angle closure compared with gonioscopy by ophthalmologist. METHODS AND ANALYSIS: Study design: prospective, multicentre, cross-sectional diagnostic accuracy study. INCLUSION CRITERIA: adults referred from community optometry to hospital with suspected angle closure. PRIMARY OUTCOME: Sensitivity and specificity. SECONDARY OUTCOMES: Positive/negative likelihood ratios, concordance, cost-effectiveness, proportion of patients requiring subsequent clinical assessment by ophthalmologist. SAMPLE SIZE: 600 individuals who have been referred with suspected angle closure from primary care (community optometry). We will have a 95% probability of detecting the true sensitivity of either test to within ±3.5% based on a sensitivity of 90%. The study would also have a 95% probability of detecting the true specificity of either test to within ±5%, assuming a specificity of 75%. ETHICS AND DISSEMINATION: Ethical Review Board approval was obtained. REC reference: 22/LO/0885. Our findings will be disseminated to those involved in eye care services. We will have a knowledge exchange event at the end of the study, published via the Health Technology Assessment web page and in specialist journals. The results will be presented at professional conferences and directly to patients via patient group meetings and the Glaucoma UK charity. TRIAL REGISTRATION NUMBER: ISRCTN15115867.

One-year surgical outcomes of the PreserFlo MicroShunt in glaucoma: a multicentre analysis.

BACKGROUND/AIMS: To evaluate the efficacy and safety of the PreserFlo MicroShunt glaucoma device in a multicentre cohort study. METHODS: All consecutive patients who received the microshunt with mitomycin-C (MMC) 0.4 mg/mL from May 2019 to September 2020 in three UK tertiary centres. Primary outcome at 1 year was a complete success, with failure defined as intraocular pressure (IOP) >21 mmHg or <20% reduction, IOP≤5 mmHg with any decreased vision on two consecutive visits, reoperation or loss of light perception vision. Secondary outcomes were IOP, best-corrected visual acuity, medications, complications, interventions and reoperations. We also performed subgroup analyses for severe glaucoma and assessed risk factors for failure. RESULTS: 104 eyes had 1-year follow-up. Complete and qualified success at 1 year were achieved in 51.9% (N=54) and 16.4% (N=17), respectively, and failure occurred in 31.7% (N=33). There was a significant reduction in IOP (mmHg) from preoperatively (23.4±0.8, N=104) to 12 months (14.7±0.6, N=104) (p<0.0001). Antiglaucoma medications also decreased from preoperatively (3.4±0.1, N=104) to 12 months (0.7±0.1, N=104) (p<0.0001). Multivariate analyses showed an association between higher mean deviation and failure (HR 1.055, 95% CI 1.0075 to 1.11, p=0.0227). Complications were hypotony (19.2%; N=20), choroidal detachments (10.6%; N=11), hyphaema (5.8%; N=6) and bleb leak (5.8%; N=6). Needling and 5-fluorouracil injections were performed in 12.5% (N=13) and 33.7% (N=35), respectively, and 11.5% (N=12) required revision surgery. CONCLUSION: The PreserFlo MicroShunt with MMC 0.4 mg/mL showed an overall success rate of 68.3% at 1 year, and led to significant IOP and medication reduction with a low rate of adverse effects.

Postoperative complications in glaucoma surgery: literature review-based recommendations to improve reporting consistency.

AIMS: To recommend a list of complications of glaucoma surgery to be used in future glaucoma surgery research and reporting by exploring the spectrum of complications' names, the variety of definitions and time frames used for reporting them in glaucoma surgical trials. METHODS: Complications' names, definitions and time frames identified from a previously conducted systematic review of glaucoma surgery trials (registration number: CRD42019121226) were reviewed. Only postoperative complications were considered. Surgical techniques described in the papers from the previous systematic review were retrieved and grouped according their mechanism of action.Reviewers independently recommended each complication's inclusion or exclusion in a list to be proposed as a potential standard for reporting in glaucoma interventions. A literature-based definition of a 'surgical complication' was used to inform these decisions. Recorded complication's details were used to inform the development of clinically relevant definitions, a consensus-driven exercise between reviewers resolved disagreements. RESULTS: We identified 48/111 (43.2%) of the reported complications as suitable for inclusion, of which 17 were merged into other included complications having a broader meaning making up a final table of 32 postoperative complications. For 25 of them, the authors kept 'names' that were previously used in the systematic review, but provided a definition that was not mentioned in these papers. Five included complications were given both 'names' and definitions not previously mentioned. The authors maintained the name and definition for one complication. There were 16 complications that were in common to all the procedures retrieved from the previous review. CONCLUSIONS: We propose a table of revised names and comprehensive definitions of postoperative complications, to simplify the process of reporting complications after glaucoma surgery and to improve consistency among surgical trials.

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.

Monocular trial of intraocular pressure-lowering medication: a prospective study.

OBJECTIVE: To investigate the validity of the monocular therapeutic trial of therapy in patients commencing topical glaucoma treatment. DESIGN: Prospective intention-to-treat cohort study of untreated patients presenting with open-angle glaucoma or ocular hypertension. PARTICIPANTS: We included 30 treatment-naïve subjects. INTERVENTION: All subjects had 8 visits at which intraocular pressure (IOP) was measured by masked Goldmann tonometry. After the recruitment visit, IOP was measured in both eyes at 11 am for 7 consecutive weeks. At week 3, travaprost (0.001%) was commenced in the eye with the higher IOP and at week 4 travaprost was also commenced in the fellow eye. MAIN OUTCOME MEASURES: Three IOP outcomes were measured for the trial eye: (1) Unadjusted IOP-lowering effect (difference between recruitment IOP and first IOP on treatment); (2) adjusted IOP-lowering effect (unadjusted effect - [difference between IOPs at the same visits in the fellow eye]); and (3) true therapeutic effect (mean difference between 3 baseline pretreatment IOPs and 3 IOPs on treatment). RESULTS: Mean recruitment IOPs were 28.2 and 26.0 mmHg in the trial and fellow eyes, respectively. The mean baseline IOPs were 25.8 and 22.7 mmHg in the trial and fellow eyes, respectively, indicating that regression to the mean was responsible for 2.4 and 3.3 mmHg, respectively, in the trial and fellow eyes. The unadjusted treatment effect (11.7 mmHg) overestimated the true effect (8.6 mmHg) by a mean of 3.1 mmHg, whereas the mean adjusted IOP was almost identical to the true effect. The correlation between the unadjusted effect of treatment and the true effect was 0.55, whereas the effect when adjusted by the monocular trial was 0.72. CONCLUSIONS: In our cohort of patients with bilateral IOPs >21 mmHg at baseline, the monocular trial provides a significantly more accurate estimate of the therapeutic response when initiating prostaglandin monotherapy in untreated eyes. It is particularly helpful in avoiding overestimation of effectiveness and so reducing the number of patients on inadequate treatment. FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any of the materials discussed in this article.

Attitudes of consultant ophthalmologists in the UK to initial management of glaucoma patients presenting with severe visual field loss: a national survey.

BACKGROUND: Recent National Institute of Clinical Excellence guidance suggests primary surgery should be offered to patients presenting with glaucoma with severe visual field loss. We undertook a survey of UK consultant ophthalmologists to determine if this represents current practice and explore attitudes towards managing patients with advanced glaucoma at presentation. DESIGN: Questionnaire evaluation study. PARTICIPANTS: All consultant ophthalmologists currently practicing in the UK. METHODS: A single-page questionnaire was posted to all consultants (n = 910) currently practicing in the UK along with a pre-paid return envelope. A second questionnaire was sent to non-responders (n = 459). MAIN OUTCOME MEASURES: Questionnaire responses. RESULTS: 626 responses were received representing 68.8% of the population surveyed. 152 (24%) volunteered a specialist interest in glaucoma. Consensus opinion for both glaucoma specialists (64.9%) and non-glaucoma specialists (62.4%) was to start with primary medical therapy, most commonly citing surgical risk as the primary reason (23% and 22%, respectively) for this approach. Most felt the highest intraocular pressure measurement during follow up (measured in clinic) was the most important variable for prevention of further visual loss (60% of glaucoma specialists and 55% of non-glaucoma specialists). Eighty-three per cent of all responders suggested they would change their practice if evidence supporting primary surgery as a safe and more effective approach existed. CONCLUSIONS: Recent National Institute of Clinical Excellence guidance does not reflect the current management approach of UK ophthalmologists. The primary concern was related to potential complications of surgery although most practitioners would be willing to change their practice if evidence existed supporting primary surgery in patients presenting with advanced glaucoma.

Outcome of repeat trabeculectomies.

BACKGROUND: To determine the success of repeat trabeculectomy augmented with mitomycin C in a cohort of patients who had undergone previously failed trabeculectomy surgery. DESIGN: A consecutive cohort series of patients. PARTICIPANTS: Fifty patients undergoing augmented trabeculectomy surgery following a previously failed trabeculectomy and at least 12 months' follow up. METHODS: All patients had demographic and clinical data collected at the time of surgery and at all subsequent follow-up visits. MAIN OUTCOME MEASURES: Visual field progression, loss of visual acuity, intraocular pressure (IOP) control. RESULTS: The mean follow up was 36.7 months. Forty-one patients (82%) achieved an IOP ≤21 mmHg (with ≥20% reduction of preoperative IOP) and ≥6 mmHg on no additional glaucoma treatment at 12 months' follow up. Forty-four patients (88%) achieved a qualified success with the same criteria at 1 year. The median logMAR acuity preoperative was unchanged after surgery; however, 11 patients (22%) lost ≥2 Snellen lines during follow up. There was no significant change in mean deviation during the follow-up period. CONCLUSIONS: Repeating trabeculectomy augmented with mitomycin C is an effective method of controlling IOP and preventing further visual deterioration in the majority of patients treated. However, visual loss was seen in a significant proportion of patients.

Lifetime visual outcomes of patients undergoing trabeculectomy.

BACKGROUND: The most important outcome for patients undergoing trabeculectomy is to maintain the quality of life in their remaining years. This study quantifies end of life vision in terms of visual acuity (VA) and visual field status. METHODS: A prospective service evaluation of patients undergoing trabeculectomy (from 2000 to 2012) who died prior to the study evaluation point (November 2018). Demographic data including socioeconomic status were collected and change in clinical measurement for the cohort between time of surgery and death was measured. RESULTS: 160 of 659 patients had died (24.3%), 4 were excluded due to insufficient data, leaving 156 patients (196 eyes) for evaluation. Male-to-female ratio was 3:2, 86% of patients were Caucasian. Mean age at surgery on first eye was 76.5 years (SD 9.0). Life expectancy post-trabeculectomy was 7.5 years (0.1-17.2). Mean change in VA was logarithm of the mean angle of resolution (LogMAR) 0.32 (SD 0.59) and visual field mean deviation progressed at a median of -0.44 dB/year (from -5.98 to 3.9) for eyes with at least a year of follow-up. Severe vision loss (loss of ≥10 letters on LogMAR) occurred in 78 eyes (40%) of which 18 (9%) were due to glaucoma, 69 patients (44%) required glaucoma drops at end of life. CONCLUSION: Trabeculectomy is successful in slowing or preventing further glaucoma progression and thus maintaining visual function in the majority of eyes for the remainder of life. For those with severe vision loss at the end of life, only one in four was due to further progression of their glaucoma.