The Impact of Baseline Intraocular Pressure on Initial Treatment Response in the LiGHT Trial: Selective Laser Trabeculoplasty versus Medication.

PURPOSE: The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial demonstrated the efficacy and safety of selective laser trabeculoplasty (SLT) compared to topical hypotensive medication as 1st-line therapy for ocular hypertension and open angle glaucoma. This sub-study explores the impact of pre-treatment (baseline) intraocular pressure (IOP) on treatment response for SLT and medication. DESIGN: Post hoc analysis of randomised control trial data. PARTICIPANTS: 1146 eyes from 662 patients were included in this analysis: 559 eyes in the SLT group and 587 in the medication group. METHODS: IOP reduction at 8 weeks following treatment with either SLT or prostaglandin analogue (PGA) eye drop initiation was assessed at different levels of baseline IOP, and the groups were compared. Differences in absolute and percentage IOP lowering between SLT and PGA medication were tested with a linear mixed effects model. Differences in the probability of achieving ≥20% IOP lowering between SLT and PGA medication, at different levels of baseline IOP, was estimated using a logistic mixed effects model. MAIN OUTCOME MEASURE: IOP lowering response to SLT versus PGA eye drops. RESULTS: Mean IOP was not significantly different between the groups, at baseline or 8 weeks following treatment initiation. Both treatments showed greater IOP lowering at higher baseline IOP and less IOP lowering at lower baseline IOP. SLT tended to achieve more IOP lowering than PGA drops at higher baseline IOP. PGA drops performed better at lower baseline IOP, and the difference compared to SLT, in terms of percentage IOP reduction, was significant at baseline IOP ≤ 17 mmHg. There was a significant difference in the relationship between baseline IOP and probability of ≥20% IOP lowering between the two treatments (p = 0.01), with SLT being more successful than PGA at baseline IOP > 22.51 mmHg. CONCLUSIONS: These data confirm previous reports of greater IOP lowering with higher baseline IOP for both SLT and topical hypotensive medication. In treatment naïve eyes, at higher baseline IOP, SLT was more successful at achieving ≥20% IOP lowering than PGA drops. At lower baseline IOP, a statistically greater percentage, but not absolute, IOP lowering was seen with PGA drops compared to SLT, although the clinical significance of this is uncertain.

Optometrist-delivered selective laser trabeculoplasty in the HES - a training protocol and early service evaluation.

Over the last decade, the delivery of glaucoma care in the UK has changed dramatically, with more non-medical ophthalmic practitioners involved in the care of glaucoma patients. Optometrists and other non-medical professionals are now involved in the delivery of laser treatments in the Hospital Eye Service (HES), but there is currently no standardised national training framework for non-medical clinicians. Moorfields Eye Hospital and UCL's Institute of Ophthalmology have developed and delivered an education and training programme for the delivery of lasers, including Selective Laser Trabeculoplasty (SLT) by non-medical ophthalmic practitioners. The training programme is based on medical education principles, is informed by previous qualitative research into the role of ophthalmic practitioners in the delivery of laser treatments and is expected to have multidisciplinary benefits for ophthalmic healthcare. Clinical audit data indicate that optometrists can deliver safe SLT treatments, adhering to local protocols.

Priorities for health outcomes in glaucoma in an ethnically diverse UK cohort: an observational study.

OBJECTIVES: To assess whether patients from minority ethnic groups have different perceptions about the quality-of-life outcomes that matter most to them. DESIGN: Cross-sectional observational study. SETTING: High volume eye centres serving the most ethnically diverse region in the UK, recruiting from July 2021 to February 2022. PARTICIPANTS: 511 patients with primary open-angle glaucoma and the predisease state of ocular hypertension. MAIN OUTCOME MEASURES: The main outcome was participants' self-reported priorities for health outcomes. RESULTS: Participants fell into one of four clusters with differing priorities for health outcomes, namely: (1) vision, (2) drop freedom, (3) intraocular pressure and (4) one-time treatment. Ethnicity was the strongest determinant of cluster membership after adjusting for potential confounders. Compared with white patients prioritising vision alone, the OR for black/black British patients was 7.31 (95% CI 3.43 to 15.57, p<0.001) for prioritising drop freedom; 5.95 (2.91 to 12.16, p<0.001) for intraocular pressure; and 2.99 (1.44 to 6.18, p=0.003) for one-time treatment. For Asian/Asian British patients, the OR was 3.17 (1.12 to 8.96, p=0.030) for prioritising intraocular pressure as highly as vision. Other ethnic minority groups also had higher ORs for prioritising health outcomes other than vision alone: 4.50 (1.03 to 19.63, p=0.045) for drop freedom and 5.37 (1.47 to 19.60, p=0.011) for intraocular pressure. CONCLUSIONS: Ethnicity is strongly associated with differing perceptions about the health outcomes that matter. An individualised and ethnically inclusive approach is needed when selecting and evaluating treatments in clinical and research settings.

Treatment expectations in glaucoma: what matters most to patients?

BACKGROUND/OBJECTIVES: Recent clinical trials in glaucoma have used patient-reported outcome measures (PROMs) of health-related quality of life to evaluate interventions. However, existing PROMs may not be sufficiently sensitive to capture changes in health status. This study aims to determine what really matters to patients by directly exploring their treatment expectations and preferences. SUBJECTS/METHODS: We conducted a qualitative study using one-to-one semi-structured interviews to elicit patients' preferences. Participants were recruited from two NHS clinics serving urban, suburban and rural populations in the UK. To be relevant across glaucoma patients under NHS care, participants were sampled to include a full range of demographic profiles, disease severities and treatment histories. Interview transcripts were evaluated using thematic analysis until no new themes emerged (saturation). Saturation was established when 25 participants with ocular hypertension, mild, moderate and advanced glaucoma had been interviewed. RESULTS: Themes identified were: Patients' experiences of living with glaucoma, patients' experiences of having glaucoma treatment, most important outcomes to patients, and COVID-related concerns. Participants specifically expressed their most important concerns, which were (i) disease-related outcomes (intraocular pressure control, maintaining vision, and being independent); and (ii) treatment-related outcomes (treatment that does not change, drop-freedom, and one-time treatment). Both disease-related and treatment-related experiences were covered prominently in interviews with patients across the spectrum of glaucoma severity. CONCLUSIONS: Outcomes related both to the disease and its treatment are important to patients with different severities of glaucoma. To accurately evaluate quality of life in glaucoma, PROMs may need to assess both disease-related and treatment-related outcomes.

Clinical risk stratification in glaucoma.

Glaucoma is the leading cause of preventable sight loss in the United Kingdom and the provision of timely glaucoma care has been highlighted as a significant challenge in recent years. Following a recent high-profile investigation, The Healthcare Safety Investigation Branch recommended the validation of risk stratification models to safeguard the vision-related quality of life of glaucoma patients. There continues to be no nationally agreed evidence-based risk stratification model for glaucoma care across the United Kingdom. Some models have used simple measures of disease staging such as visual field mean deviation as surrogates for risk, but more refined, individualised risk stratification models should include factors related to both visual impairment and visual disability. Candidate tools should also incorporate both ocular and systemic co-morbidities, rate of disease progression, visual needs and driving status and undergo clinical refinement and validation to justify implementation. The disruption to routine glaucoma care caused by the COVID-19 pandemic has only highlighted the importance of such risk stratification models and has accelerated their development, application and evaluation. This review aims to critically appraise the available evidence underpinning current approaches for glaucoma risk stratification and to discuss how these may be applied to contemporary glaucoma care within the United Kingdom. Further research will be essential to justify and validate the utility of glaucoma risk stratification models in everyday clinical practice.

Validation of the RCOphth and UKEGS glaucoma risk stratification tool 'GLAUC-STRAT-fast'.

BACKGROUND/AIMS: The aim of this study was to validate the Glaucoma Risk Stratification Tool (GLAUC-STRAT-fast) currently recommended by the Royal College of Ophthalmologists for the risk stratification of patients with glaucoma in the UK National Health Service Hospital Eye Service. METHODS: GLAUC-STRAT fast was applied to the LiGHT trial participants by risk-stratifying the worse eye of each patient at baseline and after 3 years of treatment. Metrics of disease severity or treatment intensity used for the validation were: increased number of monitoring visits or treatment escalations; needing a trabeculectomy; a reduction of >2 dB in visual field mean deviation (VF MD) during the monitoring period; identification of rapid VF loss on total (TD) and/or pattern deviation (PD). The proportion of eyes within each baseline stratum for each of the above markers was compared against the other strata, using a χ2 test for proportions. RESULTS: There was an association between the baseline stratification and the number of treatment escalations needed to maintain the eye-specific target intraocular pressure (p=0.001), the number of visits needed throughout the 3-year follow-up period (p=0.001), the need for trabeculectomy (p<0.001) and absolute loss of MD over the course of the monitoring period (p<0.001). The rate of VF progression was not associated with baseline risk stratification for TD or PD progression (p≥0.007, with Bonferroni correction). CONCLUSION: The GLAUC-STRAT fast tool is a useful tool for risk stratifying eyes with ocular hypertension or open angle glaucoma. Further research is needed to confirm and validate its applicability to more advanced glaucomas and generalisability to clinical use. TRIAL REGISTRATION NUMBER: The LiGHT trial is registered at controlled-trials.com (ISRCTN32038223).

Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial: Six-Year Results of Primary Selective Laser Trabeculoplasty versus Eye Drops for the Treatment of Glaucoma and Ocular Hypertension.

PURPOSE: The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial has shown selective laser trabeculoplasty (SLT) to be clinically and cost-effective as a primary treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT) at 3 years. This article reports health-related quality of life (HRQoL) and clinical effectiveness of initial treatment with SLT compared with intraocular pressure (IOP)-lowering eye drops after 6 years of treatment. DESIGN: Prospective, multicenter randomized controlled trial. PARTICIPANTS: Treatment-naive eyes with OAG or OHT initially treated with SLT or IOP-lowering drops. METHODS: Patients were allocated randomly to initial SLT or eye drops. After the initial 3 years of the trial, patients in the SLT arm were permitted a third SLT if necessary; patients in the drops arm were allowed SLT as a treatment switch or escalation. This study is registered at controlled-trials.com (identifier, ISRCTN32038223). MAIN OUTCOME MEASURES: The primary outcome was HRQoL at 6 years; secondary outcomes were clinical effectiveness and adverse events. RESULTS: Of the 692 patients completing 3 years in the LiGHT Trial, 633 patients (91.5%) entered the extension, and 524 patients completed 6 years in the trial (82.8% of those entering the extension phase). At 6 years, no significant differences were found for the EuroQol EQ-5D 5 Levels, Glaucoma Utility Index, and Glaucoma Quality of Life-15 (P > 0.05 for all). The SLT arm showed better Glaucoma Symptom Scale scores than the drops arm (83.6 ± 18.1 vs. 81.3 ± 17.3, respectively). Of eyes in the SLT arm, 69.8% remained at or less than the target IOP without the need for medical or surgical treatment. More eyes in the drops arm exhibited disease progression (26.8% vs. 19.6%, respectively; P = 0.006). Trabeculectomy was required in 32 eyes in the drops arm compared with 13 eyes in the SLT arm (P < 0.001); more cataract surgeries occurred in the drops arm (95 compared with 57 eyes; P = 0.03). No serious laser-related adverse events occurred. CONCLUSIONS: Selective laser trabeculoplasty is a safe treatment for OAG and OHT, providing better long-term disease control than initial drop therapy, with reduced need for incisional glaucoma and cataract surgery over 6 years.

Selective laser trabeculoplasty (SLT) performed by optometrists-enablers and barriers to a shift in service delivery.

BACKGROUND/OBJECTIVES: To explore the acceptability, training requirements, enablers and barriers of optometrist-delivered SLT. SUBJECTS/METHODS: Optometrists, fellowship and consultant grade ophthalmologists, hospital managers and patients were interviewed using pre-defined topic guides. Interviews were audio-recorded, transcribed, and subjected to thematic analysis. Overarching themes were defined by the study aims and the topic guides; subthemes were derived from the interview data. RESULTS: Sixty-six participants (three managers, eight glaucoma specialist consultant ophthalmologists, seven clinical glaucoma fellows, 12 optometrists (two of them performing SLT), two ophthalmic nurses and 34 patients) participated in the study. Overarching themes (and subthemes) were: necessity of non-medical SLT delivery, clinical practice and training, advantages, disadvantages, concerns, challenges, community delivery of SLT, patient values and other healthcare professionals that could also deliver SLT. CONCLUSIONS: Certain clinical pre-requisites, such as gonioscopy and independent prescribing rights, were perceived as necessary for undertaking SLT training. An optometrist-delivered SLT service was expected to benefit the NHS, but there was an identified need of a standardised training scheme and robust governance. Patients were accepting of an optometrist-delivered SLT service in the hospital eye service.

Selective laser trabeculoplasty (SLT) performed by optometrists for patients with glaucoma and ocular hypertension: a scoping review.

Selective laser trabeculoplasty (SLT) has been established as an effective treatment to lower intraocular pressure in people with glaucoma and ocular hypertension. The procedure is typically within the remit of ophthalmologists; however, there is potential to upskill optometrists and other healthcare professionals (HCPs) to deliver the treatment. We conducted a scoping review to identify the current global landscape of HCP-delivered SLT and describe training features, clinical effectiveness and safety. Relevant articles were identified through online database searches and grey literature sources. Four articles were selected for full inclusion. This review identified training programmes for optometrist-delivered SLT in the UK and the USA. The findings indicate that more research is needed to clarify training requirements and clinical effectiveness.

Selective laser trabeculoplasty (SLT) performed by optometrists for patients with glaucoma and ocular hypertension: a scoping review protocol.

INTRODUCTION: In the UK, the National Institute for Health and Clinical Excellence are amending guidelines to support use of selective laser trabeculoplasty (SLT) as a first-line treatment for patients with glaucoma and ocular hypertension. The procedure is quick, effective in lowering intraocular pressure, cost-effective for the National Health Service and offers an equivalent safety profile to other therapies. The procedure is typically performed by an ophthalmologist; however, there is potential for suitably trained non-medical professionals to deliver the therapy. This scoping review will identify service delivery models where SLT is delivered by non-medical professionals worldwide, with a focus on optometrists. METHODS AND ANALYSIS: A systematic search of the following databases will be conducted: CINAHL; MEDLINE Complete; Embase; HMIC and Ovid Emcare. For inclusion, studies must examine healthcare models of SLT delivery by optometrists and describe one of the following outcomes: training procedures; clinical effectiveness; safety and cost-effectiveness. A search of grey literature will be conducted via professional societies; national health departments; medicine regulatory bodies; charities and conference proceedings. Two reviewers will independently screen titles, abstracts and full-texts articles, followed by charting of data. This evidence synthesis will summarise findings narratively, supplemented with tables and descriptive statistics. ETHICS AND DISSEMINATION: The review focuses on published articles and therefore ethical approval is not required. The findings will be relevant to key stakeholders including health service managers, policymakers, clinicians and patients. The findings of this review will be disseminated through peer-reviewed publications, conference presentations and summary reports for key stakeholders.

Visual Field Outcomes from the Multicenter, Randomized Controlled Laser in Glaucoma and Ocular Hypertension Trial (LiGHT).

PURPOSE: To compare visual field outcomes of ocular hypertensive and glaucoma patients treated first with medical therapy with those treated first with selective laser trabeculoplasty (SLT). DESIGN: Secondary analysis of patients from the Laser in Glaucoma and Ocular Hypertension study, a multicenter randomized controlled trial. PARTICIPANTS: Three hundred forty-four patients (588 eyes) treated first with medical therapy and 344 patients (590 eyes) treated first with SLT. METHODS: Visual fields (VFs) were measured using standard automated perimetry and arranged in series (median length and duration, 9 VFs over 48 months). Hierarchical linear models were used to estimate pointwise VF progression rates, which were then averaged to produce a global progression estimate for each eye. Proportions of points and patients in each treatment group with fast (<-1 dB/year) or moderate (<-0.5 dB/year) progression were compared using log-binomial regression. MAIN OUTCOME MEASURES: Pointwise and global progression rates of total deviation (TD) and pattern deviation (PD). RESULTS: A greater proportion of eyes underwent moderate or fast TD progression in the medical therapy group compared with the SLT group (26.2% vs. 16.9%; risk ratio [RR], 1.55; 95% confidence interval [CI], 1.23-1.93; P < 0.001). A similar pattern was observed for pointwise rates (medical therapy, 26.1% vs. SLT, 19.0%; RR, 1.37; 95% CI, 1.33-1.42; P < 0.001). A greater proportion of pointwise PD rates were categorized as moderate or fast in the medical therapy group (medical therapy, 11.5% vs. SLT, 8.3%; RR, 1.39; 95% CI, 1.32-1.46; P < 0.001). No statistical difference was found in the proportion of eyes that underwent moderate or fast PD progression (medical therapy, 9.9% vs. SLT, 7.1%; RR, 1.39; 95% CI, 0.95, 2.03; P = 0.0928). CONCLUSIONS: A slightly larger proportion of ocular hypertensive and glaucoma patients treated first with medical therapy underwent rapid VF progression compared with those treated first with SLT.

Efficacy of Repeat Selective Laser Trabeculoplasty in Medication-Naive Open-Angle Glaucoma and Ocular Hypertension during the LiGHT Trial.

PURPOSE: To determine the efficacy of repeat selective laser trabeculoplasty (SLT) in medication-naive open-angle glaucoma (OAG) and ocular hypertensive (OHT) patients requiring repeat treatment for early to medium-term failure during the Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. DESIGN: Post hoc analysis of SLT treatment arm of a multicenter prospective randomized controlled trial. PARTICIPANTS: Treatment-naive OAG or OHT requiring repeat 360-degree SLT within 18 months. Retreatment was triggered by predefined IOP and disease-progression criteria (using objective individualized target IOPs). METHODS: After SLT at baseline, patients were followed for a minimum of 18 months after second (repeat) SLT. A mixed-model analysis was performed with the eye as the unit of analysis, with crossed random effects to adjust for correlation between fellow eyes and repeated measures within eyes. Kaplan-Meier curves plot the duration of effect. MAIN OUTCOME MEASURES: Initial (early) IOP lowering at 2 months and duration of effect after initial and repeat SLT. RESULTS: A total of 115 eyes of 90 patients received repeat SLT during the first 18 months of the trial. Pretreatment IOP before initial SLT was significantly higher than before retreatment IOP of repeat SLT (mean difference, 3.4 mmHg; 95% confidence interval [CI], 2.6-4.3 mmHg; P < 0.001). Absolute IOP reduction at 2 months was greater after initial SLT compared with repeat SLT (mean difference, 1.0 mmHg; 95% CI, 0.2-1.8 mmHg; P = 0.02). Adjusted absolute IOP reduction at 2 months (adjusting for IOP before initial or repeat laser) was greater after repeat SLT (adjusted mean difference, -1.1 mmHg, 95% CI, -1.7 to -0.5 mmHg; P = 0.001). A total of 34 eyes were early failures (retreatment 2 months after initial SLT) versus 81 later failures (retreatment >2 months after initial SLT). No significant difference in early absolute IOP reduction at 2 months after repeat SLT was noted between early and later failures (mean difference, 0.3 mmHg; 95% CI, -1.1 to 1.8 mmHg; P = 0.655). Repeat SLT maintained drop-free IOP control in 67% of 115 eyes at 18 months, with no clinically relevant adverse events. CONCLUSIONS: These exploratory analyses demonstrate that repeat SLT can maintain IOP at or below target IOP in medication-naive OAG and OHT eyes requiring retreatment with at least an equivalent duration of effect to initial laser.

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.

Primary Selective Laser Trabeculoplasty for Open-Angle Glaucoma and Ocular Hypertension: Clinical Outcomes, Predictors of Success, and Safety from the Laser in Glaucoma and Ocular Hypertension Trial.

PURPOSE: To report clinical efficacy, predictors of success, and safety of primary selective laser trabeculoplasty (SLT) used in treatment-naive patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). DESIGN: Post hoc analysis of a multicenter, prospective, randomized, controlled trial. PARTICIPANTS: Treatment-naive patients with OAG or OHT. METHODS: Patients randomized to SLT or topical medication and treated to predefined target intraocular pressures (IOPs) requiring ≥20% IOP reduction from baseline for all disease severity levels. OUTCOME MEASURES: Initial (early) absolute IOP-lowering at 2 months. Achievement of drop-free disease-control: meeting target IOP without disease progression or need for additional topical medication over 36 months after SLT. Predictors of early absolute IOP-lowering and drop-free disease-control after single initial SLT. Frequency of laser-related complications. RESULTS: A total of 611 eyes (195 OHT and 416 OAG) of 355 patients received SLT, and 622 eyes (185 OHT and 437 OAG) of 362 patients received topical medication at baseline. Early absolute IOP-lowering after SLT was no different between OHT and OAG eyes (adjusted mean difference = -0.05 mmHg; 95% confidence interval [CI], -0.6 to 0.5 mmHg; P = 0.85). No difference was noted in early absolute IOP-lowering between topical medication and primary SLT (adjusted mean difference = -0.1 mmHg; 95% CI, -0.6 to 0.4 mmHg; P = 0.67). Early absolute IOP-lowering with primary SLT was positively associated with baseline IOP (coefficient 0.58; 95% CI, 0.53-0.63; P < 0.001) and negatively with female gender (coefficient -0.63; 95% CI, -1.23 to -0.02; P = 0.04). At 36 months, 536 eyes (87.7% of 611 eyes) of 314 patients (88.5% of 355 patients) were available for analysis. Some 74.6% of eyes (400 eyes) treated with primary SLT achieved drop-free disease-control at 36 months; 58.2% (312 eyes) after single SLT. Total SLT power and 2-month IOP were predictors of drop-free disease-control at 36 months after single SLT. Six eyes of 6 patients experienced immediate post-laser IOP spike (>5 mmHg from pretreatment IOP) with 1 eye requiring treatment. CONCLUSIONS: Primary SLT achieved comparable early absolute IOP-lowering in OHT versus OAG eyes. Drop-free disease-control was achieved in approximately 75% eyes at 36 months after 1 or 2 SLTs, the majority of these after single SLT. These analyses are exploratory but support primary SLT to be effective and safe in treatment-naive OAG and OHT eyes.

Cost Effectiveness of Treatments for Diabetic Retinopathy: A Systematic Literature Review.

BACKGROUND: Diabetic retinopathy (DR) affects approximately one-third of people diagnosed with diabetes, can be sight-threatening, and generates significant human and economic burden. Over the last 2 decades, newer therapies have emerged, offering significant clinical benefits, however at a cost. Given the scarcity of available budgets, the cost effectiveness of these newer treatments is of vital importance to policy makers. METHODS: A systematic review was conducted in the PubMed, EMBASE, Cochrane, HEED and CRD databases to find and evaluate economic evaluations assessing the cost effectiveness of alterative DR treatments. Studies were assessed for their eligibility, findings and quality, and are presented in this systematic review. RESULTS: Of the 5254 studies retrieved from the literature search, 17 were included in this review. For patients with proliferative DR, when early pars plana vitrectomy was compared with pan-retinal laser photocoagulation, similar cost per quality-adjusted life-year (QALY) was observed between the two. Treatment with either intravitreal ranibizumab (IVR) or intravitreal bevacizumab (IVB) falls within acceptable cost-effectiveness thresholds in the diabetic macular oedema (DMO) population; however, in the non-DMO population, the marginal benefit of IVR or IVB in relation to the marginal cost relative to laser does not justify their use. Among the anti-vascular endothelial growth factor (VEGF) therapies, IVB appears more attractive from an economic point of view due to its lower cost. For patients with DMO, studies indicate that a combination therapy of IVR or IVB with laser and, to a lesser degree, as monotherapy, are cost effective relative to laser monotherapy; IVR plus laser is cost effective relative to laser plus triamcinolone; and laser combined with triamcinolone injections is reportedly more cost effective over IVR for pseudophakic eyes only. Moreover, fluocinolone implants appear cost effective compared with sham implants, or when treating refractory DMO. IVR administered either pro re nata (PRN) or as 'treat and extend' dominated intravitreal aflibercept (IVA) in a few studies. On the other hand, IVR monotherapy or with laser (as well as IVA) does not compare favourably relative to IVB monotherapy or with laser. CONCLUSIONS: Interpretation of cost-effectiveness data should be treated with caution in this case; details of the therapeutic regimen, such as dosage and frequency, and clinical efficacy of the treatments should be considered in relation to policy-making decisions. Given the scarcity of resources, the ever-increasing significance of health technology assessment, and the substantial differences in the methodologies of the studies presented in this review, there is a pressing need for more advanced and standardised approaches to assessing the effectiveness and cost effectiveness of the emerging anti-VEGF pharmacotherapies for the treatment of DMO.

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.

Clinical effectiveness of the Manchester Glaucoma Enhanced Referral Scheme.

BACKGROUND: Glaucoma referral filtering schemes have operated in the UK for many years. However, there is a paucity of data on the false-negative (FN) rate. This study evaluated the clinical effectiveness of the Manchester Glaucoma Enhanced Referral Scheme (GERS), estimating both the false-positive (FP) and FN rates. METHOD: Outcome data were collected for patients newly referred through GERS and assessed in 'usual-care' clinics to determine the FP rate (referred patients subsequently discharged at their first visit). For the FN rate, glaucoma suspects deemed not requiring referral following GERS assessment were invited to attend for a 'reference standard' examination including all elements of assessment recommended by National Institute for Health and Care Excellence (NICE) by a glaucoma specialist optometrist. A separate 33 cases comprising randomly selected referred and non-referred cases were reviewed independently by two glaucoma specialist consultant ophthalmologists to validate the reference standard assessment. RESULTS: 1404 patients were evaluated in GERS during the study period; 651 (46.3%) were referred to the Hospital Eye Service (HES) and 753 (53.6%) were discharged. The FP rate in 307 assessable patients referred to the HES was 15.5%. This study reviewed 131 (17.4%) of those patients not referred to the HES through the GERS scheme; 117 (89.3%) were confirmed as not requiring hospital follow-up; 14 (10.7%) required follow-up, including 5 (3.8%) offered treatment. Only one patient (0.8%) in this sample met the GERS referral criteria and was not referred (true FN). There were no cases of missed glaucoma or non-glaucomatous pathology identified within our sample. CONCLUSION: The Manchester GERS is an effective glaucoma filtering scheme with a low FP and FN rate.