Prevalence, risk factors and management of ocular hypertension or glaucoma in patients with Vogt-Koyanagi-Harada disease.

BACKGROUND/AIMS: This study was performed to examine the prevalence, risk factors and treatment outcome of OHT/glaucoma in Chinese patients with Vogt-Koyanagi-Harada (VKH). METHODS: Retrospective non-interventional case series were conducted on a total of 2281 patients with VKH referred from April 2008 to April 2019. Of these cases, 1457 had a minimum follow-up period of 3 months and were included for this study. Medical records were reviewed for demographic, ocular and treatment data. RESULTS: Among 2914 eyes of 1457 patients with VKH, 695 (23.9%) eyes of 425 patients (29.2%) developed OHT/glaucoma. The risk factors of OHT/glaucoma included initial BCVA of 20/200 or worse (OR=4.826), final best-corrected visual acuity (BCVA) of 20/50-20/100 (OR=5.341) and final BCVA of 20/200 or worse (OR=4.235), the interval between uveitis attack and referral time interval being 2 months or more (OR=3.318), more than three recurrent episodes (OR=4.177) and posterior synechiae (OR=1.785). The main possible mechanisms of OHT/glaucoma were inflammatory factor-induced open-angle OHT/glaucoma in 277 eyes (39.9%) and pupillary block arising from complete posterior synechiae in 201 eyes (28.9%). In these 695 eyes with OHT/glaucoma, normalised intraocular pressure (IOP) was achieved in 389 eyes (56.0%) following medical treatment. In the remaining 306 eyes, various surgical interventions were performed and a normalised IOP could be achieved in 249 eyes (81.4%). CONCLUSION: OHT/glaucoma is a common complication in Chinese patients with VKH. Risk factors of OHT/glaucoma included worse acuity at first and final visits, the longer interval between uveitis attack and referral, more recurrent episodes and posterior synechiae.

Evaluation and treatment of glaucoma 24hours a day. Where are we and where are we going? / Evaluación y tratamiento del glaucoma durante las 24 horas del día. ¿Dónde estamos y hacia dónde vamos?

Current management of glaucoma generally involves medical, laser, or surgical treatment in order to achieve an intraocular pressure (IOP) control which is commensurate with either stability or delayed progression of the disease. Although the follow-up of glaucoma patients is usually carried out with sporadic and isolated intraocular pressure measurements, the literature already indicates that this might not the best option to manage glaucoma patients. This article reviews the importance of 24hours intraocular pressure monitoring based on studies and publications that exist in this regard to date. A critical review on the methodology of these publications has been conducted. The need is stressed for further studies on the intraocular pressure patterns in different types of glaucoma, as well as the pattern with different therapies used in glaucoma aimed at optimising the management of the disease.

Incidence and Management of Glaucoma or Glaucoma Suspect in the First Year After Pediatric Lensectomy.

Importance: Glaucoma can occur following cataract removal in children, and determining the risk for and factors associated with glaucoma and glaucoma suspect in a large cohort of children after lensectomy can guide clinical practice. Objective: To estimate the incidence of glaucoma and glaucoma suspect and describe its management in the first year following lensectomy in children before 13 years of age. Design, Setting, and Participants: A multicenter clinical research registry containing data for 1361 eyes of 994 children who underwent unilateral or bilateral lensectomy between June 2012 and July 2015 at 1 of 61 sites in the United States (n = 57), Canada (n = 3), and the United Kingdom (n = 1). Patients were eligible for inclusion in the study if they were enrolled in the registry within 45 days after lensectomy and had at least 1 office visit between 6 and 18 months after lensectomy. Patient data were reviewed, and glaucoma and glaucoma suspect were diagnosed by investigators using standardized criteria. Statistical analysis was performed between June 2017 and August 2019. Exposures: Clinical care 6 to 18 months after lensectomy. Main Outcomes and Measures: Incidence risk using standardized definitions of glaucoma and glaucoma suspect after lensectomy. Results: Among 702 patients included in this cohort study, 353 (50.3%) were male and 427 (60.8%) were white; mean age at lensectomy was 3.4 years (range, 0.04-12.9 years). After lensectomy, glaucoma or glaucoma suspect was diagnosed in 66 of 970 eyes (adjusted overall incidence risk, 6.3%; 95% CI, 4.8%-8.3%). Glaucoma was diagnosed in 52 of the 66 eyes, and glaucoma suspect was diagnosed in the other 14 eyes. Mean age at lensectomy in these 66 eyes was 1.9 years (range, 0.07-11.2 years), and 40 of the 66 (60.6%) were eyes of female patients. Glaucoma surgery was performed in 23 of the 66 eyes (34.8%) at a median of 3.3 months (range, 0.9-14.8 months) after lensectomy. The incidence risk of glaucoma or glaucoma suspect was 15.7% (99% CI, 10.1%-24.5%) for 256 eyes of infants 3 months or younger at lensectomy vs 3.4% (99% CI, 1.9%-6.2%) for 714 eyes of infants older than 3 months (relative risk, 4.57; 99% CI, 2.19-9.57; P < .001) and 11.2% (99% CI, 7.6%-16.7%) for 438 aphakic eyes vs 2.6% (99% CI, 1.2%-5.6%) for 532 pseudophakic eyes (relative risk, 4.29; 99% CI, 1.84-10.01; P < .001). No association was observed between risk of developing glaucoma or glaucoma suspect and any of the following variables: sex, race/ethnicity, laterality of lensectomy, performance of anterior vitrectomy, prelensectomy presence of anterior segment abnormality, or intraoperative complications. Conclusions and Relevance: This study found that glaucoma or glaucoma suspect developed in a small number of eyes in the first year after lensectomy and may be associated with aphakia and younger age at lensectomy. Frequent monitoring for signs of glaucoma following lensectomy is warranted, especially in infants 3 months or younger at lensectomy and in children with aphakia after lensectomy.

Selective laser trabeculoplasty versus drops for newly diagnosed ocular hypertension and glaucoma: the LiGHT RCT.

BACKGROUND: Newly diagnosed open-angle glaucoma (OAG) and ocular hypertension (OHT) are habitually treated with intraocular pressure (IOP)-lowering eyedrops. Selective laser trabeculoplasty (SLT) is a safe alternative to drops and is rarely used as first-line treatment. OBJECTIVES: To compare health-related quality of life (HRQoL) in newly diagnosed, treatment-naive patients with OAG or OHT, treated with two treatment pathways: topical IOP-lowering medication from the outset (Medicine-1st) or primary SLT followed by topical medications as required (Laser-1st). We also compared the clinical effectiveness and cost-effectiveness of the two pathways. DESIGN: A 36-month pragmatic, unmasked, multicentre randomised controlled trial. SETTINGS: Six collaborating specialist glaucoma clinics across the UK. PARTICIPANTS: Newly diagnosed patients with OAG or OHT in one or both eyes who were aged ≥ 18 years and able to provide informed consent and read and understand English. Patients needed to qualify for treatment, be able to perform a reliable visual field (VF) test and have visual acuity of at least 6 out of 36 in the study eye. Patients with VF loss mean deviation worse than -12 dB in the better eye or -15 dB in the worse eye were excluded. Patients were also excluded if they had congenital, early childhood or secondary glaucoma or ocular comorbidities; if they had any previous ocular surgery except phacoemulsification, at least 1 year prior to recruitment or any active treatment for ophthalmic conditions; if they were pregnant; or if they were unable to use topical medical therapy or had contraindications to SLT. INTERVENTIONS: SLT according to a predefined protocol compared with IOP-lowering eyedrops, as per national guidelines. MAIN OUTCOME MEASURES: The primary outcome was HRQoL at 3 years [as measured using the EuroQol-5 Dimensions, five-level version (EQ-5D-5L) questionnaire]. Secondary outcomes were cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness and safety. RESULTS: Of the 718 patients enrolled, 356 were randomised to Laser-1st (initial SLT followed by routine medical treatment) and 362 to Medicine-1st (routine medical treatment only). A total of 652 (91%) patients returned the primary outcome questionnaire at 36 months. The EQ-5D-5L score was not significantly different between the two arms [adjusted mean difference (Laser-1st - Medicine-1st) 0.01, 95% confidence interval (CI) -0.01 to 0.03; p = 0.23] at 36 months. Over 36 months, the proportion of visits at which IOP was within the target range was higher in the Laser-1st arm (93.0%, 95% CI 91.9% to 94.0%) than in the Medicine-1st arm (91.3%, 95% CI 89.9% to 92.5%), with IOP-lowering glaucoma surgery required in 0 and 11 patients, respectively. There was a 97% probability of Laser-1st being more cost-effective than Medicine-1st for the NHS, at a willingness to pay for a quality-adjusted life-year of £20,000, with a reduction in ophthalmology costs of £458 per patient (95% of bootstrap iterations between -£585 and -£345). LIMITATION: An unmasked design, although a limitation, was essential to capture any treatment effects on patients' perception. The EQ-5D-5L questionnaire is a generic tool used in multiple settings and may not have been the most sensitive tool to investigate HRQoL. CONCLUSIONS: Compared with medication, SLT provided a stable, drop-free IOP control to 74.2% of patients for at least 3 years, with a reduced need for surgery, lower cost and comparable HRQoL. Based on the evidence, SLT seems to be the most cost-effective first-line treatment option for OAG and OHT, also providing better clinical outcomes. FUTURE WORK: Longitudinal research into the clinical efficacy of SLT as a first-line treatment will specify the long-term differences of disease progression, treatment intensity and ocular surgery rates between the two pathways. TRIAL REGISTRATION: Current Controlled Trials ISRCTN32038223. 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. 23, No. 31. See the NIHR Journals Library website for further project information.

Glaucoma is an eye condition in which the optic nerve becomes damaged and, if left untreated, will lead to loss of vision. Ocular hypertension (OHT) is the medical name for high pressure in the eye that increases the risk of getting glaucoma. Lowering the eye pressure is the only known way to prevent glaucoma from getting worse. Before this trial, the standard initial treatment of these conditions was the prescription of eyedrops to lower the pressure in the eye. An alternative is a laser therapy that is known to reduce the eye pressure. This study investigated if starting treatment of glaucoma or OHT with laser therapy (using eyedrops later, if needed) affected the patients' quality of life (QoL) more or less than starting treatment with eyedrops alone. The study also investigated if initial treatment with laser and initial treatment with eyedrops are equally good at controlling eye pressure and are equally safe and how much they cost the NHS. Patients were randomly assigned to starting treatment with either laser or eyedrops and the two groups were then compared. The study found that for the first 3 years QoL was similar regardless of treatment. However, three-quarters of patients initially treated with laser did not need any eyedrops to control their eye pressure for 3 years. Patients initially treated with laser were less likely to require cataract surgery, and none needed any glaucoma surgery in the first 3 years. In contrast, among those patients treated with eyedrops, glaucoma surgery was required in 11 eyes (out of 622 eyes). Initial treatment with laser was cheaper than initial treatment with eyedrops. The results of this study suggest that laser is an efficient, safe and cheaper alternative to eyedrops, and that three-quarters of the patients initially treated with laser do not need any eyedrops for the first 3 years of treatment.

Selective laser trabeculoplasty versus eye drops for first-line treatment of ocular hypertension and glaucoma (LiGHT): a multicentre randomised controlled trial.

BACKGROUND: Primary open angle glaucoma and ocular hypertension are habitually treated with eye drops that lower intraocular pressure. Selective laser trabeculoplasty is a safe alternative but is rarely used as first-line treatment. We compared the two. METHODS: In this observer-masked, randomised controlled trial treatment-naive patients with open angle glaucoma or ocular hypertension and no ocular comorbidities were recruited between 2012 and 2014 at six UK hospitals. They were randomly allocated (web-based randomisation) to initial selective laser trabeculoplasty or to eye drops. An objective target intraocular pressure was set according to glaucoma severity. The primary outcome was health-related quality of life (HRQoL) at 3 years (assessed by EQ-5D). Secondary outcomes were cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness, and safety. Analysis was by intention to treat. This study is registered at controlled-trials.com (ISRCTN32038223). FINDINGS: Of 718 patients enrolled, 356 were randomised to the selective laser trabeculoplasty and 362 to the eye drops group. 652 (91%) returned the primary outcome questionnaire at 36 months. Average EQ-5D score was 0·89 (SD 0·18) in the selective laser trabeculoplasty group versus 0·90 (SD 0·16) in the eye drops group, with no significant difference (difference 0·01, 95% CI -0·01 to 0·03; p=0·23). At 36 months, 74·2% (95% CI 69·3-78·6) of patients in the selective laser trabeculoplasty group required no drops to maintain intraocular pressure at target. Eyes of patients in the selective laser trabeculoplasty group were within target intracoluar pressure at more visits (93·0%) than in the eye drops group (91·3%), with glaucoma surgery to lower intraocular pressure required in none versus 11 patients. Over 36 months, from an ophthalmology cost perspective, there was a 97% probability of selective laser trabeculoplasty as first treatment being more cost-effective than eye drops first at a willingness to pay of £20 000 per quality-adjusted life-year gained. INTERPRETATION: Selective laser trabeculoplasty should be offered as a first-line treatment for open angle glaucoma and ocular hypertension, supporting a change in clinical practice. FUNDING: National Institute for Health Research, Health and Technology Assessment Programme.

Cost-effectiveness analysis of iStent trabecular micro-bypass stent for patients with open-angle glaucoma in Colombia.

OBJECTIVE: To estimate the cost-effectiveness of trabecular micro bypass stent vs laser trabeculoplasty or medications only, for patients with open-angle glaucoma in a setting of the Colombian System Health. METHODS: This is a cost-effectiveness analysis that based its assumptions in external data sources, used to extrapolate the quality-of-life related to health, survival, and costs. A Markov model, with stages from 0 (ocular hypertension without glaucoma) to 5 and bilateral blindness, was developed inclusive of Colombians older than 40 years in 2018, from a societal perspective, comparing trabecular micro-bypass stents vs laser trabeculoplasty, timolol + dorzolamide + brimonidine, timolol + dorzolamide + latanoprost, or timolol + dorzolamide + brimatoprost, in terms of clinical and economic outcomes over a lifetime horizon. Both costs and health outcomes had an annual rate discount of 5%. Health outcomes were evaluated in terms of QALYs related with loss of visual acuity. Trabecular micro-bypass costs include the joint use of timolol, and the costs of laser trabeculoplasty include the combined use of timolol + dorzolamide. RESULTS: Trabecular micro-bypass stents were estimated to have 127,971 more discounted QALYs vs laser trabeculoplasty; 405,982 vs timolol + dorzolamide + brimonidine; and 378,287 vs timolol + dorzolamide + latanoprost or timolol + dorzolamide + brimatoprost. Cumulative costs with trabecular micro-bypass stents at 40 years was $13,252,318 lower than laser trabeculoplasty; $6,403,534, lower than timolol + dorzolamide + brimonidine; $22,311,064, lower than timolol + dorzolamide + latanoprost; and $29,156,113 lower than timolol + dorzolamide + brimatoprost. CONCLUSIONS: The trabecular micro-bypass stent is a highly cost-saving strategy due to more QALYs related to a lower rate of the population with loss of visual acuity in the long-term, and because the costs associated with additional medications and complications are lower with trabecular micro-bypass stents.

Shared Cared for Stable Glaucoma Patients: Economic Benefits and Patient-centered Outcomes of a Feasibility Trial.

PURPOSE: The purpose of this article is to assess the quality of care and economic benefits of a shared care model managing patients with stable glaucoma in a primary eye care (PEC) clinic compared with a tertiary specialist outpatient clinic (SOC) in Singapore. PATIENTS AND METHODS: A randomized equivalence feasibility trial was preformed comparing the PEC with SOC models. Participants recruited from the SOC had no visual field progression or change in management for at least 3 years, were on a maximum of a single glaucoma medication, had no previous tube-shunt implant and were at least 3-year posttrabeculectomy surgery.Primary outcomes were clinical assessment and management, economic benefits, and patient satisfaction. Differences were analyzed using equivalence testing and generalized odds ratios. RESULTS: The trial included 233 patients, consisting of 42.1% glaucoma disc suspects (PEC: 47.4%; SOC: 36.8%), 27.5% primary angle closure suspects (PEC: 25.0%; SOC: 29.9%), 13.7% with ocular hypertension (PEC: 13.8%; SOC: 13.7%), 3.9% with primary angle closure glaucoma (PEC: 4.3%; SOC: 3.4%), and 3.0% with primary open angle glaucoma (PEC: 1.7%; SOC: 4.3%). Glaucoma clinical care for patients at PEC was as good as SOC [rate difference, 6.83%; 95% confidence interval (CI), 2.84-11.12) and management (rate difference, 7.69%; 95% CI, 3.21-12.17). In 23 cases (9.9%), 5.2% at PEC and 14.5% at SOC, there was disconcordance with the gold standard of senior consultant. Patient satisfaction at the PEC was equally high when compared with SOC (generalized odds ratio, 1.43; CI, 0.50-2.00). Direct costs per patient visit were 43% lower at PEC compared with SOC. CONCLUSION: Managing stable glaucoma patients at a primary care setting is a cost saving, safe, and effective shared care while enhancing professional collaboration between hospital and community settings.

[Diagnosis and treatment of ocular hypertension].

Ocular hypertension is popular among people, with a prevalence of 3% to 10% in those older than 40 years old. Without proper intervention, over 10% of the patients with ocular hypertension would develop glaucoma in the following 5 to 10 years. Glaucoma has become one of the leading causes of blindness all over the world, which makes it essential for us to pay enough attention to the prevention and treatment of ocular hypertension. However, it is not cost-effective to treat all the patients with ocular hypertension. Certain side effects may also be caused with long-term medical treatment. Therefore, it is of great importance for ophthalmologists to identify the right time and use appropriate therapeutic methods. To introduce the knowledge of ocular hypertension, the definition, epidemiology, diagnosis, risk factors and treatment of ocular hypertension are reviewed in this article. (Chin J Ophthalmol, 2016, 52: 542-546).

Treatment of ocular hypertension: is it cost effective?

PURPOSE OF REVIEW: The review evaluates the past 18-month literature related to cost-effectiveness of treating ocular hypertension (OHT) and give an opinion of the state of research. RECENT FINDINGS: Three studies question the value of intensive monitoring in OHT and glaucoma. One study suggests that implementing Ocular Hypertension Treatment Study - European Glaucoma Prevention Study (OHTS-EGPS) risk prediction in every day practice overestimates the risk of open-angle glaucoma. While two models suggest that treating all intraocular pressures above 21 mmHg would be cost-saving (but disagree on the impact of this strategy on conversion to glaucoma), another study in turn suggests than we could safely reduce medications in almost half of the patients. Two studies suggest that effective early treatment could decrease follow-up costs in OHT and one modeling study suggests that using laser in preference to medication would be cost effective in glaucoma. SUMMARY: The results of this time-limited review are confusing as they challenge many current beliefs to continue to do more than what we are currently doing. We have a huge gap in understating whether we are currently doing the 'right' things in our every day practices.

Assessment and diagnosis of suspected glaucoma in patients with mucopolysaccharidosis.

PURPOSE: The mucopolysaccharidoses (MPS) are a group of rare lysosomal storage disorders, characterized by the accumulation of glycosaminoglycans within multiple organ systems including the eye. This study aimed to determine the prevalence of glaucoma in patients with MPS, as well as the characteristics, diagnosis and management of patients with MPS and glaucoma. METHODS: A multicentre retrospective case-note review was carried out by ophthalmologists from four tertiary referral centres to identify patients with MPS who had been treated for glaucoma. Clinical ophthalmological data were collected using standardized data collection forms. RESULTS: Fourteen patients were identified (27 eyes) of 294 patients with MPS. The prevalence of glaucoma ranged from 2.1% to 12.5%. The median age at diagnosis of glaucoma was 8 years. Diagnostic evaluation of glaucoma was incomplete in many patients: intraocular pressure was documented in all eyes, but optic disc appearance was only assessed in 67%, central corneal thickness in 26%, visual fields in 19% and iridocorneal angle in 15%. CONCLUSIONS: Patients with MPS need regular assessment for possible glaucoma including during childhood. Multiple factors contribute to the challenges of assessment, diagnosis and monitoring of glaucoma in these patients.

Ocular hypertension: an approach to assessment and management.

Ocular hypertension is a common and important problem seen by eye care providers. This review presents a practical approach to individuals with ocular hypertension. It describes the common functional and structural investigations used in evaluation, as well as the advantages and disadvantages of each test. This review also discusses several landmark studies on ocular hypertension and provides a practical guide to the management of this problem.

The long term effectiveness and cost-effectiveness of initiating treatment for ocular hypertension.

PURPOSE: To investigate the long-term health and economic consequences of direct treatment initiation in ocular hypertension patients. METHODS: A cost-effectiveness analysis with a societal perspective and a lifelong horizon was performed. The primary outcomes were the incremental quality-adjusted life years (QALYs) and costs of direct pressure-lowering treatment for ocular hypertension, compared to a strategy where treatment is postponed until conversion to glaucoma has been observed. We used a decision analytic model based on individual patient simulation to forecast disease progression and treatment decisions in both strategies in a representative heterogeneous patient population and in 18 patient subgroups stratified by initial intraocular pressure and additional risk factors for conversion. RESULTS: The incremental discounted health gain of direct treatment was 0.27 QALYs, whereas the incremental discounted costs were -€ 649 during an average lifetime of 26 years. In the simulations of patient subgroups, the model outcomes moved towards higher health gains and lower incremental costs with increasing risk of conversion in the patient population. The incremental cost-effectiveness ratio of direct treatment ranged from € 15,425 per QALY gained in the lowest-risk subgroup to dominance in the highest-risk subgroup. Probabilistic sensitivity analysis indicated that uncertainty surrounding the model input parameters did not affect the conclusions. CONCLUSION: Direct, early, pressure-lowering treatment is a dominant cost-effective treatment strategy over a strategy to start the same treatment approach later, after glaucoma has occurred for patients with ocular hypertension. Its implementation and consequences should be discussed with ophthalmologists and individual patients.

Incidence and management of elevated intraocular pressure with antivascular endothelial growth factor agents.

PURPOSE: To review recent literature regarding ocular hypertension following intravitreal antivascular endothelial growth factors (anti-VEGF). METHOD: An electronic literature search was performed using MEDLINE, OVID, and PubMed. Key search terms were elevated IOP, anti-VEGF, sustained IOP elevation in anti-VEGF, chronic intraocular pressure elevation in anti-VEGF, high IOP with anti-VEGF, acute elevation in intraocular pressure with anti-VEGF, glaucoma and anti-VEGF. RESULT: Transient elevation of intraocular pressure after intravitreal anti-VEGF injection is due to temporary increase in volume, and the acute spike generally does not affect a healthy eye. Caution should be taken in a glaucomatous eye, and pretreatment with an IOP-lowering medication is recommended. Persistent elevation of intraocular pressure is more common than previously thought and may be correlated to several factors including increased number of intravitreal injections. CONCLUSION: Persistent ocular hypertension may be associated with intravitreal anti-VEGF injections. Physicians should be aware of this condition and monitor their patients for persistent ocular hypertension, especially in eyes with preexisting glaucoma. Prompt diagnosis and treatment can prevent potential loss of vision.

Direct cost and predictive factors for treatment in patients with ocular hypertension or early, moderate and advanced primary open-angle glaucoma: the CoGIS study in Germany.

BACKGROUND: The main objectives of this analysis were to assess the treatment costs and to identify major cost drivers and factors predicting direct costs in German patients with ocular hypertension (OHT) or primary open-angle glaucoma (POAG). METHODS: This non-interventional cross-sectional study was conducted in two university hospitals and 13 ophthalmology practices in Germany regions (Bavaria, Rhineland-Palatinate, North Rhine-Westphalia, Hamburg and Mecklenburg-Western Pomerania) between May 2009 and January 2010 to assess resource utilisation in patients with OHT (ICD-10: 40.0) or POAG (ICD-10: 40.1) at early, moderate or advanced stages, according to the European Glaucoma Society classification Guidelines. Treatment patterns and direct costs were evaluated retrospectively for 5 years. Resource utilisation data (medication, hospitalisation, outpatient surgery, visits to ophthalmologists) were abstracted from the charts, and unit costs were applied to estimate direct costs per year (in Euros, 2009), calculated from the perspective of the statutory health insurance in Germany (Gesetzliche Krankenversicherung). Factors predicting costs were assessed in multivariate regression analysis. RESULTS: One hundred and fifty-four patients (17.5% OHT, 27.9% early, 22.7% moderate, and 31.8% advanced POAG), on average 67 years old (SD 11) were included in the study. Average total annual direct costs per patient for OHT were 226 (SD 117), for early POAG 423 (SD 647), moderate 493 (SD 385) and advanced POAG 809 (SD 877). Glaucoma-related medications and hospitalisation represented the two major components of direct costs, increasing with the progression of glaucoma. In addition to treatment switches (p = 0.0001), factors predictive of an increase in total direct costs included the number of hospital interventions (p < 0.0001), disease-state changes since the start of treatment (p = 0.05), and current disease state (p = 0.05). CONCLUSIONS: Direct costs of treatment are higher in glaucoma compared to OHT and further increase in more severe glaucoma states. Additional treatment changes are major contributing factors to the increased treatment costs of glaucoma. If intraocular pressure can be controlled over the long term, progression to moderate and advanced states avoided, and patients remain on initial treatments, treatment costs could decline due to reduced and less expensive healthcare resource utilisation.

Protocol for a randomised controlled trial to estimate the effects and costs of a patient centred educational intervention in glaucoma management.

BACKGROUND: Poor glaucoma education is thought to be a causative factor of non-adherence to glaucoma therapy. However, the multi-factorial nature of non-adherent behaviour may explain the failure of purely educational interventions to achieve significant improvement in adherence. Behaviour Change Counselling (BCC) allows both the imparting of information and assessment of patient ambivalence to medication use and may elicit behaviour change in order to achieve better adherence. The chronic and complex nature of glaucoma means that patient non-adherence to glaucoma therapy does not easily correlate with measureable objective clinical endpoints. However, electronic medication monitoring offers an objective method of measuring adherence without reliance on clinical endpoints. METHODS/DESIGN: The study is a randomised controlled trial (RCT) with glaucoma (open angle) or ocular hypertension patients attending a glaucoma clinic and prescribed travoprost. The study will determine whether additional glaucoma education using BCC is beneficial and cost effective in improving adherence with glaucoma therapy. An 8-month follow-up period, using an electronic adherence monitoring device (Travalert dosing aid, TDA), will indicate if the intervention is likely to be sustained in the longer term. Additionally, a cost-effectiveness framework will be used to estimate the cost benefit of improving adherence. The development of a novel intervention to deliver glaucoma education using BCC required practitioner training and fidelity testing. Five practitioners were successfully trained to become Glaucoma Support Assistants able to deliver the BCC intervention. The research group had prior clinical and investigative experience in this setting, and used multiple strategies to design a method to address the study objectives. DISCUSSION: This RCT, using BCC to improve adherence to ocular hypotensive therapy, to our knowledge is the first within this disease area. Using a variety of adherence measures allows examination of the known inaccuracies of patient self-report with respect to glaucoma medication. The novel BCC component has undergone fidelity testing using BECCI and the BCC template will ensure conformity to a standardised intervention. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN89683704.

Modeling complex treatment strategies: construction and validation of a discrete event simulation model for glaucoma.

OBJECTIVE: Discrete event simulation (DES) modeling has several advantages over simpler modeling techniques in health economics, such as increased flexibility and the ability to model complex systems. Nevertheless, these benefits may come at the cost of reduced transparency, which may compromise the model's face validity and credibility. We aimed to produce a transparent report on the construction and validation of a DES model using a recently developed model of ocular hypertension and glaucoma. METHODS: Current evidence of associations between prognostic factors and disease progression in ocular hypertension and glaucoma was translated into DES model elements. The model was extended to simulate treatment decisions and effects. Utility and costs were linked to disease status and treatment, and clinical and health economic outcomes were defined. The model was validated at several levels. The soundness of design and the plausibility of input estimates were evaluated in interdisciplinary meetings (face validity). Individual patients were traced throughout the simulation under a multitude of model settings to debug the model, and the model was run with a variety of extreme scenarios to compare the outcomes with prior expectations (internal validity). Finally, several intermediate (clinical) outcomes of the model were compared with those observed in experimental or observational studies (external validity) and the feasibility of evaluating hypothetical treatment strategies was tested. RESULTS: The model performed well in all validity tests. Analyses of hypothetical treatment strategies took about 30 minutes per cohort and lead to plausible health-economic outcomes. CONCLUSION: There is added value of DES models in complex treatment strategies such as glaucoma. Achieving transparency in model structure and outcomes may require some effort in reporting and validating the model, but it is feasible.